Blood Pressure Variability and Cardiovascular Disease Events in Patients With Hypertension

NCT04342468 | Completed

• 2 other identifiers: 2017314-5047WI207736
• Study Type: observational
• Target: 1,736
• Locations: 1 country
• Sites: 1

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

Conditions

Blood Pressure Variability; Hypertension; Cardiovascular Diseases

Keywords

blood pressure variability; Hypertension; cardiovascular diseases

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• 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

Interventions

non-interventional OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients on treatment for hypertension of at least 3 years
• Patients who consent to the study

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (6)

• 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.

  PMID: 22733459 BACKGROUND

• 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.

  PMID: 20226988 BACKGROUND

• 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.

  PMID: 22025235 BACKGROUND

• 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.

  PMID: 11388815 BACKGROUND

• 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.

  PMID: 28350621 BACKGROUND

• 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.

  PMID: 27821404 BACKGROUND

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Lai M Looi, MBBS FRCPath

  University of Malaya Medical Centre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: July 14, 2017
• Primary Completion: July 4, 2019
• Study Completion: December 31, 2019
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)