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Blood Pressure Variability and Cardiovascular Disease Events in Patients With Hypertension

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04342468
Acronym
BPV
Enrollment
1736
Registered
2020-04-13
Start date
2017-07-14
Completion date
2019-12-31
Last updated
2020-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure Variability, Cardiovascular Diseases, Hypertension

Keywords

blood pressure variability, Hypertension, cardiovascular diseases

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

Interventions

OTHERnon-interventional

No intervention

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The standard deviation value of blood pressure variability in treated hypertensive patients31 Dec 2020The 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 BPV31 Dec 2020BPV 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

MeasureTime frameDescription
Percentage of Treated hypertensives with White Coat or Masked hypertension31 Dec 2020The 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.
Difference in cognition in those with higher BP variability compared to those with lower BPV31 Dec 2020The 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.

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026