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

NCT ID: NCT02121041

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Usual Care

Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

ABPM Guided

Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.

Group Type: ACTIVE_COMPARATOR

Amlodipine

Intervention Type: DRUG

Amlodipine 5 mg or 10 mg

Chlorthalidone

Intervention Type: DRUG

Chlorthalidone 12.5 mg or 25 mg

Losartan

Intervention Type: DRUG

Losartan 50 mg or 100 mg

Interventions

Amlodipine

Amlodipine 5 mg or 10 mg

Intervention Type: DRUG

Chlorthalidone

Chlorthalidone 12.5 mg or 25 mg

Intervention Type: DRUG

Losartan

Losartan 50 mg or 100 mg

Intervention Type: DRUG

Other Intervention Names

Norvasc; Thalitone; Cozaar

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role: collaborator

Anthony J Viera, MD, MPH

OTHER

Sponsor Role: lead

Responsible Party

Anthony J Viera, MD, MPH

Distinguished Associate Professor, Family Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anthony J Viera, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

14-0670

Identifier Type: -

Identifier Source: org_study_id