Essential Arterial Hypotension and Allostasis Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Relationship between Blood pressure group and comorbidities
研究概览
简要总结
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:
- Biological and physiologic systems
- External and internal environment (a) physical, b) internal behavioural and arousal state as registered by the brain.
- Their interaction.
The allostatic mechanisms to the internal and external stressors (allostatic load) involves a network composed by:
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Functional systems; mediated by:
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The Autonomic Nervous System
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The endocrine system
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The immune system
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Structural changes: whenever the internal and/or external stressors are long lasting and/or strength enough, they may induce changes in:
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Epigenetic, endophenotypes, polyphenism.
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Plasticity
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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.
详细描述
DEFINITIONS
ARTERIAL BLOOD PRESSURE CLASSIFICATION
Arterial Blood Pressure (ABP) is a complex physiological variable in regard to its measure, behavior between BP taken in the same visit at the office and between these and ABPM, chronobiology (different day time BP levels), evolution in time, meaning and classification.
Not appropriate approach or analysis may be addressed without taking into account all the BP characteristics that have demonstrated prognostic implications.
In order to arrive to the most comprehensive analysis, BP classification takes into account the following characteristics:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient regardless of the age of gender
排除标准
- •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,
- •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
结局指标
主要结局
Relationship between Blood pressure group and comorbidities
时间窗: A 7-year prospective study
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
时间窗: A 7-year prospective study
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
时间窗: A 7-year prospective study
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
次要结局
- Relationship between adaptability group, habits and anthropometric, metabolic, endocrine, Electrocardiogram, Holter, ambulatory blood pressure monitoring (ABPM)(A 7-year prospective study)
- For metabolic disorders what it matters the most: the anthropometric variables vs blood pressure group vs adaptability group(A 7-year prospective study)
- Relationship between blood pressure group, habits and anthropometric, metabolic, endocrine, Electrocardiogram, Holter, ambulatory blood pressure monitoring (ABPM)(A 7-year prospective study)
- Relationship between blood pressure group, adaptability group, habits anthropometric, metabolic, endocrine, electrocardiographic, Holter, ambulatory arterial blood pressure monitoring.(A 7-year prospective study)
研究者
Luis Eduardo Medina
Researcher
CES University