Blood Pressure Variability and Cardiovascular Disease Events in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
Cardiovascular Disease (CV) including stroke is the leading cause of death in Malaysia Hypertension is a major contributor to this. Prevalence of hypertension in Malaysia is high (42%) in adults age 30 years or older. Besides the actual blood pressure (BP) level recently, blood pressure variability (BPV) has been recognized as an independent and strong predictor of CV events especially strokes. However, data on the BP variability and its relationship to CV events is very limited in Asia, particularly in Malaysia. Hence the investigators aim to study BPV and its relationship to CV events in treated hypertensive patients

Detailed Description
-----------------
This will be a cross-sectional study on patients with hypertension. The 10-year retrospective data on BP, treatment, biochemical changes, kidney function and CV events will be extracted from patient records. Eligible patients who have given written informed consent will be given a questionnaire capturing data of their socio-demographic status, weight, height and BP measured. Those agreeable to measure their own BP at home 3 times a day for a week will be loaned a BP device to measure their own BP at home. The home BP readings will be recorded onto a provided form and returned to the investigators. Data will be analysed to determine BPV of the clinic visit-to-visit BPV (long tem BPV) determine the day to day BPV (short term BPV) examine the BPV to CV events, kidney function, cognition determine the prevalence of white coat and masked hypertension determine the level of control of BP examine the relationship of ownership of home BP devices to control and satisfaction of treatment

Official Title
-----------------
Relationship of Blood Pressure Variability and Cardiovascular Disease Events Among Patients With Hypertension

Conditions
-----------------
Blood Pressure Variability, Hypertension, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on treatment for hypertension of at least 3 years Patients who consent to the study Exclusion Criteria: those unable to give consent recent (less than 6 months) of cardiovascular events (stroke, heart attack, heart failure) patients on dialysis patients with end stage kidney failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: non-interventional|No intervention|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The standard deviation value of blood pressure variability in treated hypertensive patients | The various indices of day-to-day and long term Blood pressure variability will be calculated giving the actual BPV (in absolute number ) in these patients | 31 Dec 2020 | 
| Percentage of cardiovascular events in those with higher BPV compared to those with lower BPV | BPV will be categorized as above or below the mean BPV of the entire group. The number of CV events in percentage in each group will be compared It is expected that those with higher BPV will have more CV events | 31 Dec 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Treated hypertensives with White Coat or Masked hypertension | The Home and Clinic BP measurements will be used to determine the percentage of Masked and White Coat Hypertension. These two conditions are expected to be associated with more CV events than those with control of both clinic and home BP. | 31 Dec 2020 | 
| Difference in cognition in those with higher BP variability compared to those with lower BPV | The Montreal Cognitive Assessment (MoCA) score will be compared between those with higher with those with lower BPV. The minimum MoCA score is 0 and the maximum is 30. A higher MoCA score indicates better cognition. A MoCA score of 26 is considered as normal. The MoCA score is expected to be lower in those with higher BPV. | 31 Dec 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood pressure variability, Hypertension, cardiovascular diseases