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

• Sponsor: Anthony J Viera, MD, MPH (Other)
• Overall Status: Completed
• CT.gov ID: NCT02121041
• Collaborator: North Carolina Translational and Clinical Sciences Institute (Other)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 1.1

Study Details

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	N/A

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
• 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 1, 2014
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Jul 1, 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 Names: Norvasc ; Drug: Chlorthalidone; Chlorthalidone 12.5 mg or 25 mg; Other Names: Thalitone ; Drug: Losartan; Losartan 50 mg or 100 mg; Other Names: Cozaar

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Apr 23, 2014
• Last Update Posted: Feb 10, 2017
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Anthony J Viera, MD, MPH, Distinguished Associate Professor, Family Medicine, University of North Carolina, Chapel Hill: Hypertension; Blood Pressure; Ambulatory Blood Pressure Monitoring
• Additional relevant MeSH terms: Hypertension; Losartan; Amlodipine; Chlorthalidone

Study Results

Participant Flow

Arm/Group Title	Usual Care	ABPM Guided
Arm/Group Description	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.	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. Amlodipine: Amlodipine 5 mg or 10 mg Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg Losartan: Losartan 50 mg or 100 mg
Period Title: Overall Study
STARTED	14	14
COMPLETED	13	8
NOT COMPLETED	1	6

Baseline Characteristics

Arm/Group Title	Usual Care	ABPM Guided	Total
Arm/Group Description	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.	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. Amlodipine: Amlodipine 5 mg or 10 mg Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg Losartan: Losartan 50 mg or 100 mg	Total of all reporting groups
Overall Participants	14	14	28
Age, Customized (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.6 (12)	49.2 (10)	48.4 (11)
Gender (Count of Participants)
Female	8 57.1%	7 50%	15 53.6%
Male	6 42.9%	7 50%	13 46.4%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	ABPM Guided
Arm/Group Description	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.	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. Amlodipine: Amlodipine 5 mg or 10 mg Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg Losartan: Losartan 50 mg or 100 mg
Measure Participants	13	8
Mean (Standard Deviation) [mm Hg]	134 (11)	132 (10)

Adverse Events

Arm/Group Title	Usual Care		ABPM Guided
Arm/Group Description	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.		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. Amlodipine: Amlodipine 5 mg or 10 mg Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg Losartan: Losartan 50 mg or 100 mg
All Cause Mortality
	Usual Care		ABPM Guided
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Usual Care		ABPM Guided
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care		ABPM Guided
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/14 (7.1%)		1/14 (7.1%)
Metabolism and nutrition disorders
electrolyte	1/14 (7.1%)	1	1/14 (7.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.