We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Essential Hypotension and Allostasis Registry (EHAR)

This study is currently recruiting participants.
Verified August 2017 by Luis Eduardo Medina, CES University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02018497
First Posted: December 23, 2013
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Luis Eduardo Medina, CES University
  Purpose

The essential arterial hypotension and allostasis registry is a prospective, observational research that has the purpose of demonstrating that essential blood pressure (BP) disorders and the associated comorbidities are a result of the inappropriate allostatic response to daily life stress. This required a functioning brain orchestrating the evaluation of the threat and choosing the response, this is a mind-mediated phenomenon. If the response is excessive it contributes to high BP, if deficient to low BP, and the BP itself will identify the allostatic pattern, which in turn will play an important role in the development of the comorbidities.

To do so, consecutive patients of any age and gender that visit a cardiologist's office in Medellin, Colombia, are recruited. Individuals are classified according to their arterial BP and allostasis and follow them in time to see what kind of diseases develops the most (including BP) in the follow up according to the categorization of the characteristic chosen and after adjustment for confounder's variables. In addition, stress events with their date are registered.

HYPOTHESIS

The causes of the diseases are multifactorial.

Physical, biochemical, psychological, social, and cultural dimensions of development dynamically interact to shape the health development process.

A person´s health depends on their:

  1. Biological and physiologic systems
  2. External and internal environment (a) physical, b) internal behavioural and arousal state as registered by the brain.
  3. Their interaction.

The allostatic mechanisms to the internal and external stressors (allostatic load) involves a network composed by:

  1. Functional systems; mediated by:

    1. The Autonomic Nervous System
    2. The endocrine system
    3. The immune system
  2. Structural changes: whenever the internal and/or external stressors are long lasting and/or strength enough, they may induce changes in:

    1. Epigenetic, endophenotypes, polyphenism.
    2. Plasticity
  3. The interaction between a) and b).

The network response do not affect exclusively the BP, propitiating the development of comorbidities, which may prompt strategies for prevention, recognition and ultimately, treatment.

The allostatic model defines health as a state of responsiveness.

The concept of psycho-biotype: The allostasis is the result of both: biological (allostasis) and psychological (psychostasis) abilities. It is proposed that both components behave in similar direction and magnitude.

Immune disorders may be associated with the development of cancer. High BP population has a higher sympathetic and lower vagal tone, this has been associated with a decrease in the immune´s system function.

Resources and energy depletion: Terms like weathering have been used to describe how exposures to different allostatic loads gradually scrape away at the protective coating that keeps people healthy. It is postulated that High BP individuals have more resources and energy.


Condition
Blood Pressure Depression Panic Attack Fibromyalgia POTS Inappropriate Sinus Tachycardia Coronary Heart Disease Acute Coronary Syndrome (ACS) Acute Myocardial Infarction (AMI) Cerebrovascular Disease (CVD) Transient Ischemic Attack (TIA) Atrial Fibrillation Diabetes Mellitus Cancer Systolic Heart Failure Diastolic Heart Failure Chronic Fatigue Syndrome Syncope Vasovagal Syncope

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: Essential Arterial Hypotension and Allostasis Registry

Resource links provided by NLM:


Further study details as provided by Luis Eduardo Medina, CES University:

Primary Outcome Measures:
  • Relationship between Blood pressure group and comorbidities [ Time Frame: A 7-year prospective study ]

    Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

    Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others.

    Cardiovascular mortality Total mortality


  • Relationship between adaptability group and comorbidities [ Time Frame: A 7-year prospective study ]

    Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others.

    Cardiovascular mortality Total mortality


  • Relationship between blood pressure group, adaptability group and comorbidities [ Time Frame: A 7-year prospective study ]

    Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

    Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others.

    Cardiovascular mortality Total mortality



Secondary Outcome Measures:
  • Relationship between blood pressure group, habits and anthropometric, metabolic, endocrine, Electrocardiogram, Holter, ambulatory blood pressure monitoring (ABPM) [ Time Frame: A 7-year prospective study ]

    Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

    Habits: smoke and drink

    Anthropometric variables: Body mass index, waist, hip

    Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, homoeostasis model assessment (HOMA), total cholesterol, LDL, HDL, triglycerides.

    Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone

    Electrocardiogram: HR; PR interval, QRS complex, cQT interval

    Holter variables: HR, standard deviation of NN intervals (SDNN) and sympathovagal balance, at day, night and 24 hs.

    ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.


  • Relationship between blood pressure group, adaptability group, habits anthropometric, metabolic, endocrine, electrocardiographic, Holter, ambulatory arterial blood pressure monitoring. [ Time Frame: A 7-year prospective study ]

    Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

    Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable.

    Habits: smoke and drink

    Anthropometric variables: Body mass index, waist, hip

    Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides.

    Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone

    Electrocardiogram: PR interval, QRS complex, Heart rate, cQT interval

    Holter variables: HR, SDNN and sympathovagal balance, at day, night and 24 hs.

    ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.


  • For metabolic disorders what it matters the most: the anthropometric variables vs blood pressure group vs adaptability group [ Time Frame: A 7-year prospective study ]

    Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

    Adaptability group: 1) Hyper adaptable, 2) normal adaptability and 3) hypo adaptable.

    Habits: smoke and drink, exercise

    Anthropometric variables: Body mass index, waist, hip

    Metabolic and other variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides; thyrotropine,

    Holter variables: HR, standard deviation of NN intervals (SDNN) and sympathovagal balance, at day, night and 24 hs.

    ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.


  • Relationship between adaptability group, habits and anthropometric, metabolic, endocrine, Electrocardiogram, Holter, ambulatory blood pressure monitoring (ABPM) [ Time Frame: A 7-year prospective study ]

    Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable.

    Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip

    Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides.

    Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone

    Electrocardiogram: PR interval, QRS complex, Heart rate, cQT interval

    Holter variables: HR, SDNN and sympathovagal balance, at day, night and 24 hs.

    ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.



Other Outcome Measures:
  • Syncope Registry [ Time Frame: Up 100 weeks ]
    Clinical syncope characteristics (age of first syncope, number of syncope episodes, trauma, duration, clinical score, convulse, sphincter relaxation, etc.) Syncope cause Blood pressure group Adaptability group Prognosis

  • Tilt table testing (TTT) registry [ Time Frame: Up to 100 weeks ]

    TTT protocol: describe the protocol, the time at positive response, nitroglycerine use, autonomic and hemodynamic variables.

    TTT outcome for syncope: positive or negative TTT other outcomes: 1) Chronotropic incompetence, 2) arterial orthostatic hypotension, 3) carotid hypersensitivity, 4) POTS, 5) IST The relationship between TTT results and Clinical score for syncope in regard to: syncope behaviour and other orthostatic intolerance entities, symptoms and comorbidities.

    The relationship between neurally mediated syncope response at the TTT and comorbidities.


  • Sinus node function at the electrophysiological study (EPS) [ Time Frame: Up to 100 weeks ]
    EPS variables: AH, AV, CL, sino atrial conduction time (SACT), sinus node recovery time (SNRT), corrected sinus node recovery time (CSNRT), response to Isoproterenol, intrinsic heart rate Diagnosis: control, sick sinus syndrome, IST, chronotropic incompetence at the TTT HR at the ECG HR at the Holter monitoring HR at the TTT HRV at the Holter monitoring Syncope, cardiac or neurally mediated HR at the physical treadmill test Relationship with the blood pressure group Relationship with the adaptability group

  • Score for coronary artery disease [ Time Frame: Up to 200 weeks ]
    Define how the blood pressure group and/or the adaptability group may add to the already known and include in this registry, in the diagnosis of cardiovascular complications as coronary artery disease, cerebrovascular disease, peripheral artery disease, nephropathy.

  • Neurally Mediated Syncope: further of the transient lost of consciousness (TLC) [ Time Frame: A 7-year prospective study ]

    Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

    Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, COPD, and others.

    Mortality


  • Psychobiotype: relationship between biological and psychological variables [ Time Frame: Up to 100 weeks ]

    Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

    Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable.

    Psychiatric variables:

    1. Big Five Questionary (BFQ) for personality.
    2. Modify of the Coping Scale (Scale of modified coping strategies)
    3. Zung questionary for depression and anxiety
    4. MINI in those patients with moderate or severe depression and/or anxiety at the Zung questionary

  • The role of high sodium intake in the development of essential hypertension. Comparison between essential hypotension (high sodium intake) vs normotension population (normal or low sodium intake) in the follow-up. [ Time Frame: 4 years ]

    High sodium intake in the diet is recognized as a risk factor for hypertension development.

    Essential hypotension population is advised to increase the sodium (at least 10 grams a day) and water intake (at least 2 liters a day), or as much as possible, several have taken Fludrocortisone (is not a exclusion criteria). Normal blood pressure population are advised to have a normal or low sodium intake. Physical exercise is recommended in both groups.

    This registry is a good opportunity to test how important sodium diet is to induce hypertension, or if by the contrary adaptability could prevail over high sodium intake in this registry.

    Blood pressure groups: essential hypotension and normotension and those with new essential hypertension. Adaptability groups.

    The results will be adjusted for age, gender and BMI.


  • White coat effect in the heart rate or masked bradycardia. [ Time Frame: 1 year ]

    Consistent bradycardia in the ECG at the office and normal HR in the holter monitoring or the contrary.

    There are patients with complaints that may be attributed to bradycardia, low blood pressure, hypothyroidism, or other entities.

    Some patients very often have bradycardia in the ECG taken in the office and normal HR in the 24 Holter monitoring, the opposite is also possible.

    Patients with bradycardia (without medication or physiological condition as exersice affecting heart rate) in at least 2 ECG (less 60 bpm) and at least 2 Holter monitoring will be analyzed,

    Other variables to consider are:

    Age, gender, blood pressure group, adaptability group, maximum HR in the treadmill test, white coat or masked hypertension, Tilt-Table-test result or syncope cause, Electrophysiological study if available.

    The acknowledge of this phenomenon could have clinical implications in the diagnosis of sick sinus syndrome and physiopathological ones.


  • Reversible Bradycardia Mimicking Sinus Node Dysfunction as a Manifestation of Subacute Autonomic Nervous System Dysfunction (ANSD). [ Time Frame: 2 years ]

    Bradycardia is the classical presentation form for sinus node dysfunction, mainly when associated with symptoms. Chronotropic incompetence is also a manifestation. Absence of medications with effects on the heart rate (HR) must be ruled out.

    Variables

    1. HR at the ECG, Holter monitoring, stress text, and at the physical examination previous to pacemaker implantation,
    2. Electrophysiological study (EPS): Basic cycle length, Sino-atrial conduction time, Sinus node recovery time, Corrected sinus node recovery time, Intrinsic HR when available 3. Pacemaker variables: HR at day and night or rest time Percentage of stimulation in A and V chambers 4. Syncope: Clinical characteriscs and clinical score Tilt table test results Trans Thoracic Echocardiogram in rest and or stress text Hypothesis: patients with ANSD will start to decrease the percentage atrial stimulation.

  • Description of the blood pressure hemodynamic profile at a medical office and their prognostic implications. [ Time Frame: Three years ]

    A non invasive, beat to beat BP monitoring, with the ability to measure BP, HR, Cardiac Output and Systemic Vascular Resistance (SVR) was started to use in the EHAR registry since May 2017. A description of this variables in the three BP groups will be collected in the data base (DB).

    This will allow to characterize whether SVR and/or CO maintain BP. Until now BP levels are related with prognosis. In the prognosis model SVR and CO will be add them to know what matter the most: BP levels, SVR and/or CO? In the EHAR registry a collection of the variables recognized as a risk factor for several comorbidities are available to adjust in multivariable analysis.



Estimated Enrollment: 5000
Study Start Date: January 1995
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Consecutive patients who consult a cardiologist

Consecutive patients who consult a cardiologist - electrophysiologist since June 2006, regardless of the age or gender in the city of Medellin, Colombia. They could have consulted previously (considered as the enrollment date) if they had, at least, one measurement of their BP in supine position, and an immediate measurement of their BP in standing position that allows diagnosing their group of blood pressure. All patients have a record in paper and/or magnetic file and in OpenClinica.

No interventions.


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients that visits a cardiologist's office in Medellin, Colombia. The population consists of patients of any age and gender, which are classified according to their blood pressure in: normotensive, hypertensive and hypotensive, they are also classified according to their adaptability in hypo, normo and hyper.
Criteria

Inclusion Criteria:

  • Any patient regardless of the age of gender

Exclusion Criteria:

  • Any non-correctable secondary cause of increase or decrease in blood pressure
  • or a pathology that alters the prognosis before the entrance of the patient into this registry.
  • nephropathy prior to the admission,
  • familial dyslipidemia,
  • previous gastric bypass,
  • pre-existing heart failure,
  • chemotherapy-induced cardiotoxicity,
  • arrhythmogenic right ventricular dysplasia,
  • long QT syndrome,
  • hypertrophic cardiomyopathy
  • restrictive cardiomyopathy or sudden death syndromes other than coronary disease
  • Down syndrome,
  • having one single kidney before entering to this registry,
  • polycystic kidney,
  • disability to continue with the treatment
  • organ transplantation (other than cornea),
  • HIV positive,
  • homocystinuria,
  • myelomeningocele,
  • autoimmune diseases,
  • paraplegia,
  • chronic infections (TB),
  • myocarditis of any cause,
  • blood dyscrasia with coagulation disorders,
  • history of pulmonary embolism,
  • sustained or non-sustained ventricular tachycardia,
  • idiopathic tachycardia associated with syncope which is not cured by radiofrequency ablation,
  • pulmonary hypertension,
  • diabetes insipidus,
  • COPD,
  • Gitelman syndrome,
  • Cervical cancer associated with human Papillomavirus,
  • multiple sclerosis,
  • hemochromatosis,
  • not compact ventricle.

It is important to emphasize that all of these patients, currently excluded from the registry, may be studied in the future, they keep on follow-up and taken 6 BP.

Additionally it is planned to compare the evolution of patients with secondary causes of hypertension or hypotension with essential disorders

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018497


Contacts
Contact: Luis Eduardo Medina, MD. (574)2323218 essentialhypotension@gmail.com

Locations
Colombia
CES University Recruiting
Medellín, Antioquia, Colombia, 00
Contact: Luis E Medina, MD    (57)3104055903    essentialhypotension@gmail.com   
Sub-Investigator: Jose F Florez, PhD         
Sub-Investigator: Jose M Cotes, PhD         
Sponsors and Collaborators
CES University
Investigators
Principal Investigator: Luis Eduardo Medina, MD. Researcher
  More Information

Additional Information:
Publications:
Medina E, Uribe W, Duque M, Alzate L. Past Medical History in patients with Orthostatic Intolerance. XIth International Symposium on the Autonomic Nervous System, Puerto Rico, 24-30. October 2000. Clin Auton Res 2000, 10:258. Summary.
Medina E, Uribe W, Duque M, Alzate L. Initial Medical Complain and Symptoms in Patients with Orthostatic Intolerance. XIth International symposium on the autonomic nervous system, Puerto Rico, 24-30 October 2000. Clin Auton Res 2000, 10:258. Summary
Medina E, Uribe W, Duque M, Alzate L. Syncope characterization in patients with orthostatic intolerance. XIth International symposium on the autonomic nervous system, Puerto Rico, 24-30 October 2000. Clin Auton Res 2000, 10:243. Summary.
Medina E, Uribe W, Duque M, Alzate L. Patients with orthostatic Intolerance: are those with syncope different from those without? Is syncope an acceptable endpoint for therapy? XIth International Symposium on the Autonomic Nervous System, Puerto Rico, 24-30 October 2000. Clin Auton Res 2000, 10:243. Summary
Medina E, Uribe W, Duque M, Alzate L. Variation of arterial blood pressure and heart rate during follow up in patients with orthostatic intolerance. XIth International symposium on the autonomic nervous system, Puerto Rico, 24-30 October 2000. Summary.
Medina E, Uribe W, Duque M, Alzate L. Severity of Compromise and level of Limitation in patients with Orthostatic Intolerance. XIth International Symposium on the autonomic nervous system, Puerto Rico, 24-30 October 2000. Summary
Medina E, Uribe W, Duque M, Alzate L. Diagnosis of orthostatic intolerance based on blood pressure and heart rate characterization. Could symptoms be enough?. XIth International symposium on the autonomic nervous system, Puerto Rico, 24-30 October 2000. Summary
Medina L, Mármol A, Duque M, Ossaba S, Uribe W, Olaya M, Marín J, Torres Y, Velásquez J. The tilt table test protocol: How can be improved? Clinical Autonomic Research. Vol 14, Number 5, 2004, page. 310. October 2000. Summary
Medina L, Olaya M, Duque M, Restrepo F, Uribe W, Marín J, Velásquez J, Torres Y. Fatigue: a clue symptom in chronic orthostatic disorder. How can it be explained? Clinical Autonomic Research. Vol 14, Number 5, 2004, page. 310. October 2000. Summar
L Medina, W Uribe, M Duque, I Melguizo, JM Cotes, Y Torres, MA Restrepo, J Marín, E Gil, J Velasquez. Cardiology and autonomic nervous system department. Clínica Medellín, Universidad CES, Universidad Nacional. Medellín, Colombia. Personality type: a variable associated with biological measures in patients with orthostatic intolerance. 16th International symposium on the autonomic nervous system. Los Cabos, Mexico. October 6-9 2005. Clinical Autonomic Research. Vol 15, number 5, page 346, 2005. Summary.
L Medina, W Uribe, M Duque, I Melguizo, JM Cotes, Y Torres, MA Restrepo, J Marín, E Gil, J Velasquez. Cardiology and autonomic nervous system department. Clínica Medellín, Universidad CES, Universidad Nacional. Medellín, Colombia. Descriptive analysis and confidence limits at 95% of stress, depression, SF36, and tilt-test variables in an orthostatic intolerant population. 16th International symposium on the autonomic nervous system. Los Cabos, Mexico, October 6-9 2005. Clinical Autonomic Research. Vol 15, number 5, page 342, 2005. Summary.
L Medina, D Aristizabal, M Duque, W Uribe, I Melguizo, JM Cotes, Y Torres, MA Restrepo, J Marín, E Gil, J Velásquez, BLF Restrepo. Cardiology and autonomic nervous system department. Clínica Medellín, Universidad CES, Universidad Nacional and Universidad de Antioquia. Medellín, Colombia. Insulin and glucose metabolism in patients with orthostatic intolerance. 16th International symposium on the autonomic nervous system. Los Cabos, Mexico. October 6-9 2005. Clinical Autonomic Research. Vol 15, number 5, page 333, 2005. Summary.
L Medina, M Duque, E Gil, JM Cotes, Marín J, D Bravo, E Gonzalez, MA Restrepo, D Aristizabal, Y Torres, M Jimenez, W Uribe. Cardiology and autonomic nervous system department. Clínica Medellín, Medellín, Colombia. Applying tilt testing to diagnose sick sinus syndrome: Does it play role beyond syncope? 17th International symposium on the autonomic nervous system. Westin Riomar, Rio Grande, Puerto Rico, November 1-4 2006. Clinical Autonomic Research. Vol 16, number 5, page 349, 2006. Summary.
L Medina , J McEween, J Mendez, W Uribe, M Duque, Marín J E Gil, D Bravo, E Gonzalez, MA Restrepo, Torres Y, Cotes JM. Cardiology and autonomic nervous system department. Clínica Medellín, Medellín, Colombia. Hemodynamic effects of the 16 Gly/Arg polymorphism at the ADRB2 gene in hypotensive and hypertensive patients. 17th International symposium on the autonomic nervous system. Westin Riomar, Rio Grande, Puerto Rico, November 1-4 2006. Clinical Autonomic Research. Vol 16, Number 5, page 333, 2006. Summary.
L Medina, D Aristizabal, J McEween, J Mendez, W Uribe, Duque M, Marín J E Gil, D Bravo, E Gonzalez, MA Restrepo, Torres Y, Cotes JM. Cardiology and autonomic nervous system department. Clínica Medellín, Medellín, Colombia. Diagnostic impact of the syncope symptom score in structurally normal hearts in patients undergoing tilt table testing. 17th International Symposium on the Autonomic Nervous System. Westin Riomar, Rio Grande, Puerto Rico, November 1-4 2006. Clinical Autonomic Research. Vol 16, Number 5, page 342, 2006. Summary.
LE Medina, D Aristizabal, J Gallo, J Ochoa, Y Torres, L Montoya, M Correa, R Restrepo, D Moreno, MO Correa, N Zapata, PA Gil, M Franco. Medellin heart study. Study design and distribution by blood pressure, including hypotension. Clinical Autonomic Research. Vol 18, Number 5, page 277, 2008. (Summary).
Medina L, Duque M, Marin J, Gonzalez E, Astudillo V, Aristizabal J, Bernal J, Restrepo MA, Arroyave A, Jaramillo G, Torres Y, Uribe W. Essential hypotension registry: Sympathovagal balance at 24 hours, day and night in ambulatory Holter monitoring according to blood pressure groups in real-life settings. Clinical Autonomic Research. Vol 19, Number 5, page 300, 2009. Summary.
Medina LE, Duque M, Uribe W, Aristizabal J, Velasquez J, Restrepo MA, Miranda A, Torres Y, Marin J. The essential hypotension registry. Blood pressure at the office and at 24 h ambulatory monitoring is different between groups of essential hypertension, normotension and essential hypotension. Clinical Autonomic Research. Vol 20, number 2, page 139, 2010. Summary.
Medina LE, Marin J, Duque M, Uribe W, Mesa S, Aristizabal J, Velasquez J, Restrepo MA, Miranda A, Bernal J, Torres Y. Vasovagal syncope and their relationship with hypotension: What is the current conception and how it may change if essential hypotensive population emerges. The essential hypotension registry. Clinical Autonomic Research. Vol 21, number 2, page 127, 201. Summary
Medina L, Duque M, Marin J, Gonzalez E, Astudillo V, Aristizabal J, Bernal J, Restrepo MA, Arroyave A, Jaramillo G, Torres Y, Uribe W. Syncope diagnosis in patients with not apparent structurally heart disease and components for both: neurally mediated and cardiac origin (mixed syncope): is it a quantitative history score reliable? Clinical Autonomic Research. Vol 19, number 5, page 308, 2009. Summary.
Medina L. Essential hypotension registry. Cardiovascular Reactivity: A search for the integration of the neuro-cardiovascular relationship and their association with glucose challenge and depression. Clinical Autonomic Research. Vol 19, number 5, page 300, 2009. Summary
LE Medina, Aristizabal D, McEween J, W Uribe, Duque M, Marín J Gil E, Bravo D, Gonzalez E, Restrepo MA, Torres Y, Cotes JM. Cardiology and autonomic nervous system department. Clínica Medellín, Medellín, Colombia. Are there insulin sensitivity differences expected along the blood pressure spectrum? 17th International symposium on the autonomic nervous system. Westin Riomar, Rio Grande, Puerto Rico, November 1-4 2006. Clinical Autonomic Research. Vol 16, number 5, page 332, 2006. Summary
LE Medina, W Uribe, M Duque, E Gonzalez, G Montero, D Bravo, MA Restrepo, M Jimenez, D Aristizábal, T Torres, J Marín. Cardiology and autonomic nervous system department. Clínica Medellín, Medellín, Colombia. Does essential or primary hypotension matter? Second joint meeting of the European Federation of Autonomic Societies and the American Autonomic Society. Palais Ferstel. Vienna, Austria. October 10-13, 2007. Clinical Autonomic Research. Vol 17, number 5, page 304, 2007. Summary.
LE Medina, J Marín, W Uribe, M Duque, E Gonzalez, G Montero, D Bravo, MA Restrepo, M Jimenez, D Aristizabal. Cardiology and autonomic nervous system department. Clínica Medellín, Medellín, Colombia. Population characterization according to blood pressure. Are essential hypotensive different from other blood pressure groups? Second joint meeting of the European Federation of Autonomic Societies and the American Autonomic Society. Palais Ferstel. Vienna, Austria. October 10-13, 2007. Clinical Autonomic Research. Vol 17, number 5, page 304, 2007. Summary
LE Medina, W Uribe, J Marín, E Gonzalez, G Montero, D Bravo, MA Restrepo, M Jimenez, D Aristizabal, M Duque. Cardiology and autonomic nervous system department. Clínica Medellín, Medellín, Colombia. The importance of arterial hypotension in the chronic fatigue syndrome. Second joint meeting of the European Federation of Autonomic Societies and the American Autonomic Society. Palais Ferstel. Vienna, Austria. October 10-13, 2007. Clinical Autonomic Research. Vol 17, number 5, page 318, 2007. Summary.
LE Medina, M Duque, J Marín, E Gonzalez, G Montero, D Bravo, MA Restrepo, M Jimenez, D Aristizabal, W Uribe. Cardiology and autonomic nervous system department. Clínica Medellín, Medellín, Colombia. Are there differences in the variables hemoglobin, hematocrit and ferritin between normotensive patients and essential hypertensive and hypotensive? Second joint meeting of the European Federation of Autonomic Societies and the American Autonomic Society. Palais Ferstel. Vienna, Austria. October 10-13, 2007. Clinical Autonomic Research. Vol 17, number 5, page 311, 2007. Summary
LE Medina, J Ospina, MA Lemos, G Cuartas, D Aristizabal, J Calle, Gutierrez, Y Torres. Relationship between blood pressure, depression and anxiety. A step into the concept of psychobiotype (mind-body relationship). Clinical Autonomic Research. Vol 18, number 5, page 277, 2008. Summary
LE Medina, W Uribe, J Marin, G Montero, B Astudillo, MA Restrepo, J Bernal, Y Torres, M Duque. Blood pressure characterization in essentials hypotension and/or orthostatic hypotension. Clinical Autonomic Research. Vol 18, number 5, page 277, 2008. Summary.
Medina L, Uribe W, Marin J, Gonzalez E, Astudillo V, Aristizabal J, Velasquez J, Bernal J, Torres Y, Duque M. Chronotropic incompetence in the head-up tilt testing: a useful diagnostic marker or clinically irrelevant finding? Accepted for publication at the European Heart Journal, 2009 (Summary).
Medina L. Essential Hypotension registry: Definition, blood pressure and demographic report. Clinical Autonomic Research. Vol 19, number 5, page 308, 2009. Summary
Medina LE, Ospina J, Lemos MA, Cuartas G, Calle J, Gutierrez M, Torres Y. Essential hypotension registry: Psychometric measurements for anxiety, depression and coping strategies: Hypotension is associated with depression and anxiety. Is there a psycho-biotype? Preliminary Report. Clinical Autonomic Research. Vol 19, number 5, page 296, 2009. Summary
Medina LE, Duque M, Uribe W, Aristizabal J, Velasquez J, Restrepo MA, Miranda A, Torres Y, Marin J. It is glucose metabolism (HOMA and the relation: 2 h postprandial plasma glucose/fasting glucose) different between blood pressure groups? The essential hypotension registry. Clinical Autonomic Research. Vol 20, number 2, page 139, 2010. Summary.
Medina LE, Duque M, Marin J, Aristizabal J, Velasquez J, Miranda A, Torres Y, Restrepo MA, Uribe W. The essential hypotension registry. Rationale for the blood pressure classification and the importance of the stress response. Clinical Autonomic Research. Vol 20, number 2, page 139, 2010. Summary
Medina LE, Uribe W, Marin J, Aristizabal J, Velasquez J, Miranda A, Torres Y, Restrepo MA, Duque M. What do patients with classical and initial orthostatic hypotension, without an identifiable cause have to teach us? The essential hypotension registry. Description of the population and the blood pressure measurements. Clinical Autonomic Research. Vol 20, number 2, page 140, 2010. Summary
Medina LE, Uribe W, Marin J, Aristizabal J, Velasquez J, Miranda A, Torres Y, Restrepo MA, Duque M. The importance of essential hypotension in syncope. A report of 877 patients. The essential hypotension registry. Clinical. Autonomic Research. Vol 20, number 2, page 140, 2010. Summary
Godly F. What is health? BMJ 2011; 343: d4817
Bernard, Claude. Le phénoménes de la Vie. Paris, 1878.
Walter B Cannon, Organization for physiological homeostasis. Physiological Reviews 1929; Vol IX, No 3, 399-430.
Walter B Cannon, The Wisdom of the body. Preface and Introduction, page xiii and page 19; 1939, New York: W. M. Norton & Co
Rocci R. Un Nuovo Sphigmomanometro. Gazeta Medica Di Torino.1896; 50. December 10
Korotkoff, NC. On the question of methods of determining the blood pressure. Reports of the Imperial Military Academy, St. Petersburg, 1905; 11: 365
Cook, Henry W. Blood Pressure in Prognosis. Med Record, 1911; 80: 959-967.
The Autonomic Nervous System in Health and Disease. Edited by David S. Goldstein. Marcel Dekker editors, New York, 2001, pages 480-490.
Acelajado M, Calhoun D, Oparil S. Pathogenesis of hypertension. In: Hypertension. A Companion of Branwalds heart disease, 2nd Edition, 2013, Chapter 2, page 12, Elsevier Saunders, Philadelphia
Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Erdine S, Kiowski W, Agabiti-Rosei E, Ambrosioni E, Lindholm LH, Viigimaa M, Adamopoulos S, Agabiti-Rosei E, Ambrosioni E, Bertomeu V, Clement D, Erdine S, Farsang C, Gaita D, Lip G, Mallion JM, Manolis AJ, Nilsson PM, O'Brien E, Ponikowski P, Redon J, Ruschitzka F, Tamargo J, van Zwieten P, Waeber B, Williams B; Management of Arterial Hypertension of the European Society of Hypertension; European Society of Cardiology. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2007 Jun;25(6):1105-87. Erratum in: J Hypertens. 2007 Aug;25(8):1749.
Diseases and Conditions Index - Hypotension. National Heart Lung and Blood Institute. September 2008.
Low blood pressure (hypotension) — Definition. MayoClinic.com. Mayo Foundation for Medical Education and Research. 2009/05/23.
Medina LE, Duque M, Uribe W. Initial medical complaints in patients with orthostatic intolerance. Clin Auton Res 2000, 10: 258 (Summary).
White W, Shah H. Ambulatory blood pressure monitoring in clinical hypertension management. In: Hypertension. A Companion to Branwald Heart Disease, 2013, Second edition, Chapter 6, Page 59. Edited by Black H and Elliot W.
Patel MR, Bailey SR, Bonow RO, Chambers CE, Chan PS, Dehmer GJ, Kirtane AJ, Wann LS, Ward RP. ACCF/SCAI/AATS/AHA/ASE/ASNC/HFSA/HRS/SCCM/SCCT/SCMR/STS 2012 appropriate use criteria for diagnostic catheterization: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society of Critical Care Medicine, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012 May 29;59(22):1995-2027. doi: 10.1016/j.jacc.2012.03.003. Epub 2012 May 9.
Electrophysiological testing, Chapter 4, page 62. In: Clinical Arhythmology and Electrophysiology. A Companion of Branwald´s Heart Disease, 2nd Ed. Elsevir, Saunders 2012; Philadelphia. Edited by Ziad F. Issa, John M Miller, Douglas P. Zipes
Issa Z, Miller J, Zipes D. Sinus Node Dysfunction. In: Clinical arrhythmology and electrophysiology. A Companion to Branwald Heart Disease, 2012, Second edition, Chapter 8, Page 164. Edited by Issa Z, Miller J, Zipes D.
Medina L, Uribe W, Marin J, Gonzalez E, Astudillo V, Aristizabal J, Velasquez J, Bernal J, Torres Y, Duque M. Chronotropic incompetence in the head-up tilt testing: a useful diagnostic marker or clinically irrelevant finding? European Heart Journal, 2009 (Summary).
Inappropriate Sinus Tachycardia, Chapter 16, page 375. In: Clinical Arhythmology and Electrophysiology. A Companion of Branwald´s Heart Disease, 2nd Ed. Elsevir, Saunders 2012; Philadelphia. Edited by Ziad F. Issa, John M Miller, Douglas P. Zipes.
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24.
Zivin J. Ischemic cerebrovascular disease. In: Cecil Medicine 24th Edition, Edited by Goldman Lee and Schafer A. 2012, Elsevier Sanders, Inc. Philadelphia. Page 2304, Chapter 413.
Inzucchi S, Sherwin R. Type II Diabetes Mellitus. In: Cecil Medicine 24th Edition, Edited by Goldman Lee and Schafer A. 2012, Elsevier Sanders, Inc. Philadelphia. Page 1690, Chapter 237.

Responsible Party: Luis Eduardo Medina, Researcher, CES University
ClinicalTrials.gov Identifier: NCT02018497     History of Changes
Other Study ID Numbers: LEMD001
First Submitted: November 29, 2013
First Posted: December 23, 2013
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Luis Eduardo Medina, CES University:
Syncope
Essential arterial hypotension
Arterial hypotension
Low blood pressure
Hypotension
Essential arterial hypertension
Dysautonomia
Stress
Adaptability
Reactivity
Homeostasis
Allostasis
Allostatic load
Distress
Epigenetic
Plasticity

Additional relevant MeSH terms:
Syncope
Syncope, Vasovagal
Syndrome
Diabetes Mellitus
Heart Failure
Atrial Fibrillation
Infarction
Heart Diseases
Myocardial Infarction
Fatigue
Acute Coronary Syndrome
Fibromyalgia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Hypotension
Tachycardia
Ischemic Attack, Transient
Fatigue Syndrome, Chronic
Heart Failure, Diastolic
Cerebrovascular Disorders
Heart Failure, Systolic
Panic Disorder
Tachycardia, Sinus
Disease
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases