Essential Hypotension and Allostasis Registry

NCT02018497 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2023-09-21

No results posted yet for this study

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.

Conditions

  • 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

Sponsors & Collaborators

  • CES University

    lead OTHER

Principal Investigators

  • Luis Eduardo Medina, MD. · Researcher

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-01-31
Primary Completion
2024-03-30
Completion
2024-06-30

Countries

  • Colombia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02018497 on ClinicalTrials.gov