Trial record 6 of 9 for:    Open Studies | "Syncope, Vasovagal"

Essential Hypotension and Adaptability Registry (EssentialHAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by CES University
Sponsor:
Information provided by (Responsible Party):
Luis Eduardo Medina, CES University
ClinicalTrials.gov Identifier:
NCT02018497
First received: November 29, 2013
Last updated: February 2, 2015
Last verified: February 2015
  Purpose

The essential arterial hypotension and adaptability registry is an observational, prospective, cohort type, descriptive and comparative research about the low arterial blood pressure with no identifiable cause, in a population 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. In addition, they are also classified according to their adaptability in hypo, normal adaptability and hyper.

The aim is to evaluate how clinical, laboratory, paraclinical examinations and certain comorbidities behave between the three groups of blood pressure and adaptability in order to define the meaning of the essential hypotension and the adaptability and propose possible mechanisms mediating this relationship.

HYPOTHESIS

This hypothesis is the result of previous exploratory studies that has been already published.

Causes of the diseases (Essential Hypotension) are multifactorial.

  1. The organism's ability to adapt to stress of any kind is vital for life. Type of stress that humans are exposed most often is the psychosocial stress.
  2. The organism´s response to stress involves the autonomic nervous, the endocrine and the immune systems
  3. Stressor can be acute, sub-acute or chronic; isolated, simultaneous or repetitive; mild, moderate or severe, which will determine the total burden of stress.
  4. The organism has acute, sub-acute and chronic adaptation, and it has a limited reserve of response in each case.
  5. The individual's response to stress is not homogenous in the population, it may be: excessive, proportioned and deficient.
  6. Chronic stress requires resistance and resilience, which are also different between individuals. It is proposed that resistance and resilience to chronic stress is lower in hypotensive population and higher in hypertensives. Regarding the adaptability group, resistance and resilience is expected to be higher in hyper adaptability group and lower in the hypo. Adaptability could predominate over the blood pressure group.
  7. The adaptive response to chronic stress may contribute decisively to produce blood pressure essential disorders, high adaptation (excessive response) and low (deficient response).
  8. Essential disorders in arterial blood pressure would be an indicator of the individual's adaptability to stress, and the associated diseases would be part of the same response spectrum.
  9. The physiological disorders (metabolic) or associated diseases to stress adaptability can be: a) the result of the adaptive response (for example, blood pressure essential disorders), or b) the exhaustion of the adaptive mechanisms (for example, fibromyalgia and chronic fatigue syndrome).
  10. It is considered that most of the individual's functions have their base in the Central Nervous System, which has a limited ability to fulfill these functions. If the reserve is low and the challenge too severe and prolonged, the Central nervous system would begin to relegate some functions and prioritize in others. Those relegated functions (such as pain control) may cause diseases such as fibromyalgia.
  11. The concept of essential: If the diseases afflicting an important mass of the population may be the result of the body's response to stress, in an attempt to maintain homeostasis, it is postulated that both the magnitude and direction of this response must have a distribution that is between one and two standard deviations of the Gaussian curve (see Figure 3), probably more or less than others.
  12. The concept of psychobiotype: The homeostasis (allostasis) is the result of both: biological (biostasis) and psychological (psychostasis) abilities. This concept propose that both components behave in similar direction and magnitude. For example, the hypotensive patients would fall their blood pressure by assuming the standing position (orthostatic stress), the blood glucose may fall within the first 2 hours of a 75 grams of glucose challenge (reactive hypoglycemia, metabolic challenge) (Figure 4) and they would have an increased susceptibility to stress (psychological stress), that may cause depression, among other pathologies. These responses would not be presented consistently in time.
  13. Immnune disorders may be associated with the development of cancer. High blood pressure population has a higher sympathetic and lower vagal tone, this have been associated with a decrease in the immune system function, and could explain eventual association between the essential high blood pressure group and cancer.

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 Adaptability Registry

Resource links provided by NLM:


Further study details as provided by CES University:

Primary Outcome Measures:
  • Relationship between Blood pressure group and comorbidities [ Time Frame: A 7-year prospective study ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 5000
Study Start Date: January 1995
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: February 2015 (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

Genders Eligible for Study:   Both
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 or complex 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 29, 2013
Last Updated: February 2, 2015
Health Authority: Colombia: instituto nacional de vigilancia de medicamentos y alimentos INVIMA

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

Additional relevant MeSH terms:
Syncope, Vasovagal
Acute Coronary Syndrome
Atrial Fibrillation
Cerebrovascular Disorders
Coronary Artery Disease
Coronary Disease
Fatigue Syndrome, Chronic
Fibromyalgia
Heart Failure
Heart Failure, Diastolic
Heart Failure, Systolic
Hypotension
Ischemic Attack, Transient
Myocardial Infarction
Myocardial Ischemia
Syncope
Syndrome
Tachycardia
Tachycardia, Sinus
Angina Pectoris
Arrhythmias, Cardiac
Arterial Occlusive Diseases
Arteriosclerosis
Autonomic Nervous System Diseases
Brain Diseases
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Chest Pain
Consciousness Disorders

ClinicalTrials.gov processed this record on August 02, 2015