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Blood Pressure VariabilityBPVNCT04342468

Blood Pressure Variability and Cardiovascular Disease Events in Patients With Hypertension

An observational study of Blood Pressure Variability and Hypertension, run by University of Malaya at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
non-interventional
How many people
1,736 participants
Where
1 siteMalaysia
Study dates
14 Jul 2017to 31 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • University of Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

Other trials in Malaysia

About this study

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

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

Read the 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
Being tested
non-interventional
Keywords
blood pressure variability, Hypertension, cardiovascular diseases
Medical subject headings
Hypertension, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non-interventionalOther

    No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 31 Dec 2020

  2. 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

    Measured: 31 Dec 2020

Secondary outcomes (2)

  1. 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.

    Measured: 31 Dec 2020

  2. 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.

    Measured: 31 Dec 2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2020
  2. Study start14 Jul 2017
  3. Primary completion4 Jul 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
1,736 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04342468
Sponsor's protocol ID
2017314-5047
Other IDs
WI207736
Acronym
BPV
Status last verified
Apr 2020
First submitted
8 Apr 2020
Last updated
16 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data are only useful for this study

Publications

  • 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.

    PubMed 22733459

  • 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.

    PubMed 20226988

  • 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.

    PubMed 22025235

  • 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.

    PubMed 11388815

  • 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.

    PubMed 28350621

  • 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.

    PubMed 27821404

Questions about this trial

What is this clinical trial studying?

An observational study of Blood Pressure Variability and Hypertension, run by University of Malaya at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The standard deviation value of blood pressure variability in treated hypertensive patients (time frame: 31 Dec 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04342468, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.

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