Essential Hypotension and Adaptability Registry (EssentialHAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 23, 2014
Last verified: May 2014
  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 inflammatory 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 (Figure 1).
  6. Chronic stress requires resistance and resilience, which are also different between individuals (Figure 1). It is proposed that chronic stress is lower in hypotensive and higher in hypertensive (but the adaptability group could predominate over the blood pressure group).
  7. The adaptive response to chronic stress may contribute decisively to produce blood pressure essential disorders (Figure 2), high (excessive response) and low (deficient response).
  8. Essential disorders in 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 or associated diseases to stress adaptability can be: a) the result of the adaptive response (for example, blood pressure essential disorders), or b) the lack of ability to adapt (for example, fibromyalgia and chronic fatigue syndrome) (Figure 1).
  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.

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: June 2014 (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. 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 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, 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
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. No abstract available. Erratum in: J Hypertens. 2007 Aug;25(8):1749.
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.

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: May 23, 2014
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:
Diabetes Mellitus
Depression
Heart Failure
Myocardial Infarction
Infarction
Heart Diseases
Atrial Fibrillation
Acute Coronary Syndrome
Fibromyalgia
Myofascial Pain Syndromes
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypotension
Tachycardia
Syncope
Ischemic Attack, Transient
Heart Failure, Diastolic
Syndrome
Fatigue Syndrome, Chronic
Syncope, Vasovagal
Heart Failure, Systolic
Cerebrovascular Disorders
Tachycardia, Sinus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014