Blood Pressure Variability and Cardiovascular Disease Events in Patients With Hypertension

Hypertension Clinical Trial

— BPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342468
• Other study ID #: 2017314-5047
• Secondary ID: WI207736
• Status: Completed
• Start date: July 14, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1736
• Est. completion date: December 31, 2019
• Est. primary completion date: July 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure Variability
• Cardiovascular Diseases
• Hypertension

Intervention

Other:
• non-interventional
No intervention

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Centre	Kuala Lumpur	Federal Territory

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (6)

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. — View 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). pii: e003825. — View 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. — View 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. — View 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. — View Citation

Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlöf 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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