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Clinical Trials/NCT04342468
NCT04342468
Completed
Not Applicable

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

University of Malaya1 site in 1 country1,736 target enrollmentJuly 14, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blood Pressure Variability
Sponsor
University of Malaya
Enrollment
1736
Locations
1
Primary Endpoint
The standard deviation value of blood pressure variability in treated hypertensive patients
Status
Completed
Last Updated
6 years ago

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 1. determine BPV of the clinic visit-to-visit BPV (long tem BPV) 2. determine the day to day BPV (short term BPV) 3. examine the BPV to CV events, kidney function, cognition 4. determine the prevalence of white coat and masked hypertension 5. determine the level of control of BP 6. examine the relationship of ownership of home BP devices to control and satisfaction of treatment

Registry
clinicaltrials.gov
Start Date
July 14, 2017
End Date
December 31, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Professor Chia Yook Chin

Professor

University of Malaya

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

Outcomes

Primary Outcomes

The standard deviation value of blood pressure variability in treated hypertensive patients

Time Frame: 31 Dec 2020

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

Percentage of cardiovascular events in those with higher BPV compared to those with lower BPV

Time Frame: 31 Dec 2020

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

Secondary Outcomes

  • Percentage of Treated hypertensives with White Coat or Masked hypertension(31 Dec 2020)
  • Difference in cognition in those with higher BP variability compared to those with lower BPV(31 Dec 2020)

Study Sites (1)

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