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Completed

NCT Number: NCT02121041

Ambulatory vs Office BP Management Usual Care for Diagnosing and Managing Hypertension: A Pilot Study

The purpose of this study is to compare the effectiveness of ambulatory blood pressure monitoring to usual care (blood pressure measurement in the office) in diagnosing and managing hypertension.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

The usual strategy for detecting hypertension-repeated office blood pressure (BP) measurements-is inefficient and inaccurate. When paired with ambulatory BP monitoring (ABPM), which takes a multitude of measurements over 24 hours, it is clear that office BP measurements may convey a falsely positive diagnosis known as white-coat hypertension. What is less well-known is that office BP measurements may also convey a falsely negative diagnosis termed masked hypertension (MH). That is, office BP may measure as normal, yet 24-hour ambulatory measurements show elevated BP. People with MH have cardiovascular risk that is similar to that of people with diagnosed hypertension, yet MH goes unrecognized, and therefore, untreated. Ultimately, identifying the best strategy for accurately detecting hypertension is vital to improving overall BP control and reducing cardiovascular events. Without a feasible ABPM strategy, MH will continue to go unrecognized and untreated.

Participants enrolled in the study will be randomized to either the usual care group or the ABPM-guided group. All participants will have a baseline ABPM. ABPM will be used to make a diagnosis and determine anti-hypertensive treatment in the ABPM-guided group only. Participants in the ABPM-guided group will have a follow-up ABPM in 2 months. All participants will have a final ABPM 4 months after enrollment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 30 years and ≤ 65 years
  • Most recent (within 14 days) clinic systolic BP 126-150 mm Hg
  • Able/willing to wear a BP monitor for 24 hours on multiple occasions
  • Able/willing to take daily anti-hypertensive medication if indicated
  • Able to read and speak English

Exclusion criteria

  • Pregnant or trying to become pregnant
  • Known heart disease
  • History of persistent atrial fibrillation
  • Currently taking antihypertensive medication
  • Currently taking Simvastatin > 20mg daily
  • Clinician recommends against participation

Treatment and study plan

Amlodipine

Drug

Amlodipine 5 mg or 10 mg

Other names: Norvasc

Chlorthalidone

Drug

Chlorthalidone 12.5 mg or 25 mg

Other names: Thalitone

Losartan

Drug

Losartan 50 mg or 100 mg

Other names: Cozaar

Primary outcomes

  1. 24 Hour Blood Pressure Average at the End of 4 Month Participation.

    Time frame: Participants will be on study average of 4 months.

Sponsors and collaborators

Lead sponsor

Anthony J Viera, MD, MPH

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute

Registry information

Official study title

Comparative Effectiveness of Ambulatory Blood Pressure Monitoring vs Usual Care for Diagnosing and Managing Hypertension: A Pilot Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 23, 2014
Registry last updated
Feb 10, 2017

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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