Blood Pressure Variability and Cardiovascular Disease Events in Patients With Hypertension

NCT ID: NCT04342468

Last Updated: 2020-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1736 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-14

Study Completion Date

2019-12-31

Brief Summary

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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

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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

Conditions

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Blood Pressure Variability Hypertension Cardiovascular Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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non-interventional

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Professor Chia Yook Chin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lai M Looi, MBBS FRCPath

Role: STUDY_DIRECTOR

University of Malaya Medical Centre

Locations

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University of Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

References

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Mancia G. Short- and long-term blood pressure variability: present and future. Hypertension. 2012 Aug;60(2):512-7. doi: 10.1161/HYPERTENSIONAHA.112.194340. Epub 2012 Jun 25. No abstract available.

Reference Type BACKGROUND
PMID: 22733459 (View on PubMed)

Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlof B, Sever PS, Poulter NR. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet. 2010 Mar 13;375(9718):895-905. doi: 10.1016/S0140-6736(10)60308-X.

Reference Type BACKGROUND
PMID: 20226988 (View on PubMed)

Muntner P, Joyce C, Levitan EB, Holt E, Shimbo D, Webber LS, Oparil S, Re R, Krousel-Wood M. Reproducibility of visit-to-visit variability of blood pressure measured as part of routine clinical care. J Hypertens. 2011 Dec;29(12):2332-8. doi: 10.1097/HJH.0b013e32834cf213.

Reference Type BACKGROUND
PMID: 22025235 (View on PubMed)

Rogers MA, Small D, Buchan DA, Butch CA, Stewart CM, Krenzer BE, Husovsky HL. Home monitoring service improves mean arterial pressure in patients with essential hypertension. A randomized, controlled trial. Ann Intern Med. 2001 Jun 5;134(11):1024-32. doi: 10.7326/0003-4819-134-11-200106050-00008.

Reference Type BACKGROUND
PMID: 11388815 (View on PubMed)

Chia YC, Ching SM, Lim HM. Visit-to-visit SBP variability and cardiovascular disease in a multiethnic primary care setting: 10-year retrospective cohort study. J Hypertens. 2017 May;35 Suppl 1:S50-S56. doi: 10.1097/HJH.0000000000001333.

Reference Type BACKGROUND
PMID: 28350621 (View on PubMed)

Chia YC, Lim HM, Ching SM. Long-Term Visit-to-Visit Blood Pressure Variability and Renal Function Decline in Patients With Hypertension Over 15 Years. J Am Heart Assoc. 2016 Nov 7;5(11):e003825. doi: 10.1161/JAHA.116.003825.

Reference Type BACKGROUND
PMID: 27821404 (View on PubMed)

Other Identifiers

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WI207736

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2017314-5047

Identifier Type: -

Identifier Source: org_study_id

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