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NCT Number: NCT04342468

Blood Pressure Variability and Cardiovascular Disease Events in 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

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Key information

Conditions

Blood Pressure Variability Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

About this study

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

  • determine BPV of the clinic visit-to-visit BPV (long tem BPV)
  • determine the day to day BPV (short term BPV)
  • examine the BPV to CV events, kidney function, cognition
  • determine the prevalence of white coat and masked hypertension
  • determine the level of control of BP
  • examine the relationship of ownership of home BP devices to control and satisfaction of treatment

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

No intervention

Primary outcomes

  1. The standard deviation value of blood pressure variability in treated hypertensive patients

    Time frame: 31 Dec 2020

    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

  2. Percentage of cardiovascular events in those with higher BPV compared to those with lower BPV

    Time frame: 31 Dec 2020

    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

Secondary outcomes

  1. Percentage of Treated hypertensives with White Coat or Masked hypertension

    Time frame: 31 Dec 2020

    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.

  2. Difference in cognition in those with higher BP variability compared to those with lower BPV

    Time frame: 31 Dec 2020

    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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Acronym: BPV

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2020
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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