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Blood Pressure | Essential Hypotension and Allostasis Registry

Blood Pressure research study

What is the primary objective of this study?

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 is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

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 Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Consecutive patients who consult a cardiologistConsecutive 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.

Study Status

Recruiting

Start Date: January 1995

Completed Date: January 2020

Phase: N/A

Type: Observational [Patient Registry]

Design:

Primary Outcome: Relationship between Blood pressure group and comorbidities

Secondary Outcome: Relationship between blood pressure group, habits and anthropometric, metabolic, endocrine, Electrocardiogram, Holter, ambulatory blood pressure monitoring (ABPM)

Study sponsors, principal investigator, and references

Principal Investigator: Luis Eduardo Medina, MD.

Lead Sponsor: CES University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02018497

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.

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