UnknownNot Applicable

Essential Hypotension and Allostasis Registry

Colombia5,000 participantsStarted 1995-01

Plain-language summary

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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ke…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Relationship between Blood pressure group and comorbidities

Timeframe: A 7-year prospective study

Relationship between adaptability group and comorbidities

Timeframe: A 7-year prospective study

Relationship between blood pressure group, adaptability group and comorbidities

Timeframe: A 7-year prospective study

Trial details

NCT IDNCT02018497

SponsorCES University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03-30

Contact for this trial

Luis Eduardo Medina, MD.

(574)2323218 essentialhypotension@gmail.com

View on ClinicalTrials.gov More Blood Pressure trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Relationship between Blood pressure group and comorbidities

Timeframe: A 7-year prospective study

Relationship between adaptability group and comorbidities

Timeframe: A 7-year prospective study

Relationship between blood pressure group, adaptability group and comorbidities

Timeframe: A 7-year prospective study