High Altitude Cerebral Edema

Dexamethasone 3.3 mg/mL solution for injection

Dexamethasone

Sodium Chloride 0.9% w/v solution for injection

Placebo

University Hospitals Coventry and Warwickshire NHS Trust

Spectroscopic and Diffusion Weighted Analysis of the Effects of Dexamethasone on High Altitude Cerebral Oedema (HACE)

Differences in oedematous changes in the brain and spinal cord as measured by changes in brain and spinal cord MRI imaging

To assess the role of primary blood brain barrier breakdown in hypoxic cytotoxic oedema as measured by variation in serum markers

Change in glial specific (GFAP) and non-glial specific (purines) serum biomarkers from baseline and at 8, 11, 22 and 26 hours post hypoxic insult

To develop a hypoxic spinal cord model for use in future research looking into complex vascular surgery.

Individual participant data will not be shared with other researchers

Double-blind, randomised controlled trial

The participant, Investigator supervising the visit and the Outcome Assessor will be blinded to the treatment allocation

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.

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

CES University

Essential Hypotension and Allostasis Registry

Essential Arterial Hypotension and Allostasis Registry

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

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

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

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.

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.

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.

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.

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

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.

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

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.

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

Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.
Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable.
Psychiatric variables:
Big Five Questionary (BFQ) for personality.
Modify of the Coping Scale (Scale of modified coping strategies)
Zung questionary for depression and anxiety
MINI in those patients with moderate or severe depression and/or anxiety at the Zung questionary

High sodium intake in the diet is recognized as a risk factor for hypertension development.
Essential hypotension population is advised to increase the sodium (at least 10 grams a day) and water intake (at least 2 liters a day), or as much as possible, several have taken Fludrocortisone (is not a exclusion criteria). Normal blood pressure population are advised to have a normal or low sodium intake. Physical exercise is recommended in both groups.
This registry is a good opportunity to test how important sodium diet is to induce hypertension, or if by the contrary adaptability could prevail over high sodium intake in this registry.
Blood pressure groups: essential hypotension and normotension and those with new essential hypertension. Adaptability groups.
The results will be adjusted for age, gender and BMI.

Consistent bradycardia in the ECG at the office and normal HR in the holter monitoring or the contrary.
There are patients with complaints that may be attributed to bradycardia, low blood pressure, hypothyroidism, or other entities.
Some patients very often have bradycardia in the ECG taken in the office and normal HR in the 24 Holter monitoring, the opposite is also possible.
Patients with bradycardia (without medication or physiological condition as exersice affecting heart rate) in at least 2 ECG (less 60 bpm) and at least 2 Holter monitoring will be analyzed,
Other variables to consider are:
Age, gender, blood pressure group, adaptability group, maximum HR in the treadmill test, white coat or masked hypertension, Tilt-Table-test result or syncope cause, Electrophysiological study if available.
The acknowledge of this phenomenon could have clinical implications in the diagnosis of sick sinus syndrome and physiopathological ones.

Bradycardia is the classical presentation form for sinus node dysfunction, mainly when associated with symptoms. Chronotropic incompetence is also a manifestation. Absence of medications with effects on the heart rate (HR) must be ruled out.
Variables
HR at the ECG, Holter monitoring, stress text, and at the physical examination previous to pacemaker implantation,
Electrophysiological study (EPS): Basic cycle length, Sino-atrial conduction time, Sinus node recovery time, Corrected sinus node recovery time, Intrinsic HR when available 3. Pacemaker variables: HR at day and night or rest time Percentage of stimulation in A and V chambers 4. Syncope: Clinical characteriscs and clinical score Tilt table test results Trans Thoracic Echocardiogram in rest and or stress text Hypothesis: patients with ANSD will start to decrease the percentage atrial stimulation.

A non invasive, beat to beat BP monitoring, with the ability to measure BP, HR, Cardiac Output and Systemic Vascular Resistance (SVR) was started to use in the EHAR registry since May 2017. A description of this variables in the three BP groups will be collected in the data base (DB).
This will allow to characterize whether SVR and/or CO maintain BP. Until now BP levels are related with prognosis. In the prognosis model SVR and CO will be add them to know what matter the most: BP levels, SVR and/or CO? In the EHAR registry a collection of the variables recognized as a risk factor for several comorbidities are available to adjust in multivariable analysis.

aortic aneurysm/fatigue

Spectroscopic and Diffusion Weighted Analysis of the Effects of Dexamethasone on High Altitude Cerebral Oedema (HACE)

Essential Hypotension and Allostasis Registry

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