Clinical trial NCT04342468: Blood Pressure Variability and Cardiovascular Disease Events in Patients With Hypertension
Official title: Relationship of Blood Pressure Variability and Cardiovascular Disease Events Among Patients With Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure Variability
Hypertension
Cardiovascular Diseases
Keywords: blood pressure variability
Hypertension
cardiovascular diseases
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 1736
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with hypertension on follow up at the primary care clinic of University of Malaya Medical Centre who fulfill the inclusion and exclusion criteria are eligible to be enrolled into the study

Eligible patients were recruited in a consecutive manner

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

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

Primary outcomes:
measure: The standard deviation value of blood pressure variability in treated hypertensive patients
timeFrame: 31 Dec 2020
measure: Percentage of cardiovascular events in those with higher BPV compared to those with lower BPV
timeFrame: 31 Dec 2020
Secondary outcomes:
measure: Percentage of Treated hypertensives with White Coat or Masked hypertension
timeFrame: 31 Dec 2020
measure: Difference in cognition in those with higher BP variability compared to those with lower BPV
timeFrame: 31 Dec 2020
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
state: Federal Territory
Study officials:
affiliation: University of Malaya Medical Centre
name: Lai M Looi, MBBS FRCPath
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.