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

• ClinicalTrials.gov Identifier: NCT02121041
• Recruitment Status: Completed
• First Posted: April 23, 2014
• Results First Posted: December 19, 2016
• Last Update Posted: February 10, 2017
• Sponsor: Anthony J Viera, MD, MPH
• Collaborator: North Carolina Translational and Clinical Sciences Institute
• Information provided by (Responsible Party): Anthony J Viera, MD, MPH, University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: Amlodipine; Drug: Chlorthalidone; Drug: Losartan	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparative Effectiveness of Ambulatory Blood Pressure Monitoring vs Usual Care for Diagnosing and Managing Hypertension: A Pilot Study
• Study Start Date: May 2014
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: July 2016

Arms and Interventions

Arm	Intervention/treatment
No Intervention: 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.
Active Comparator: 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.	Drug: Amlodipine; Amlodipine 5 mg or 10 mg; Other Name: Norvasc; Drug: Chlorthalidone; Chlorthalidone 12.5 mg or 25 mg; Other Name: Thalitone; Drug: Losartan; Losartan 50 mg or 100 mg; Other Name: Cozaar

Outcome Measures

Primary Outcome Measures :

1. 24 Hour Blood Pressure Average at the End of 4 Month Participation. [ Time Frame: Participants will be on study average of 4 months. ]

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, North Carolina

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

Anthony J Viera, MD, MPH

North Carolina Translational and Clinical Sciences Institute

Investigators

• Principal Investigator: Anthony J Viera, MD, MPH; University of North Carolina

More Information

• Responsible Party: Anthony J Viera, MD, MPH, Distinguished Associate Professor, Family Medicine, University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02121041
• Other Study ID Numbers: 14-0670
• First Posted: April 23, 2014
• Results First Posted: December 19, 2016
• Last Update Posted: February 10, 2017
• Last Verified: December 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Anthony J Viera, MD, MPH, University of North Carolina, Chapel Hill:

Hypertension; Blood Pressure; Ambulatory Blood Pressure Monitoring

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Losartan; Amlodipine; Chlorthalidone; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents; Anti-Arrhythmia Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Diuretics; Natriuretic Agents; Sodium Chloride Symporter Inhibitors