The Use of Ambulatory Blood Pressure Monitors to Assess Angiotensin Converting Enzyme Inhibitors

May 23, 2017 updated by: John Bucheit, Pharm.D.,BCACP, CDE, Memorial Health University Medical Center

The Use of Ambulatory Blood Pressure Monitors to Assess Angiotensin Converting Enzyme Inhibitors in Resistant Hypertension

The purpose of this study is to use ambulatory blood pressure monitors to investigate whether enalapril is superior to lisinopril in managing nocturnal hypertension in patients with resistant hypertension currently treated with daytime angiotensin converting enzyme inhibitors.

Study Overview

Detailed Description

Resistant hypertension is defined as blood pressure > 140/90 mm Hg while adherent to three or more antihypertensive medications or < 140/90 mm Hg treated with four or more antihypertensives. Patients with resistant hypertension may be at risk for elevated nighttime blood pressure >120/70 mm Hg and "non-dipping" (night/day blood pressure > 0.9). A higher rate of cardiovascular events occur during the "morning surge" partially attributed elevated nighttime blood pressure due to increased renin angiotensin aldosterone system (RAAS) activity. Angiotensin converting enzyme inhibitors (ACEIs) suppress RAAS activity

This prospective randomized parallel-group pilot study will occur at Memorial Family Medicine. Eligible patients will undergo three study visits over a 5-8 week span. After providing written informed consent, patients will complete an initial screening visit assessing 25 hour blood pressure using ambulatory blood pressure monitors. Patients will continue the study if they are found to have a nighttime blood pressure >120/70 mm Hg. Patients continuing the study will be randomly assigned to equivalent dose lisinopril or enalapril treatment arms and their administration time will be changed to "bedtime." At the final visit, patients will complete a final ambulatory blood pressure analysis to reassess nighttime blood pressure and dipping status.

It's expected that patients with enalapril treatment will have superior nighttime blood pressure reduction compared to the lisinopril treatment group. If the expected outcome occurs, more patients in the enalapril group will meet their nighttime blood pressure goal (<120/70 mm Hg) and exhibit a "dipping pattern." Current evidence suggests that patients with normal nighttime blood pressure and dipping pattern are at a lower risk for cardiovascular morbidity and mortality.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Georgia
      • Savannah, Georgia, United States, 31404
        • Recruiting
        • Memorial Family Medicine Center
        • Contact:
        • Principal Investigator:
          • John Bucheit, Pharm.D.
        • Sub-Investigator:
          • Cindy Gleit, M.D.
        • Sub-Investigator:
          • Kathryn Momary, Pharm.D.
        • Sub-Investigator:
          • Angela Kaylor, R.N.
        • Sub-Investigator:
          • Daniel Gordon, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with clinic blood pressure > 140/90 mm Hg on 3 antihypertensives or clinic blood pressure < 140/90 mm Hg on 4 antihypertensives
  • Currently treated with an angiotensin converting enzyme inhibitor

Exclusion Criteria:

  • Chronic kidney disease (CKD) stage 4 or worse
  • Pheochromocytoma
  • Unstable cardiovascular disease Stroke, Transient Ischemic Attack, Unstable Angina, or Myocardial infarction in the last 30 days
  • Hyperaldosteronism
  • Current pregnancy
  • Shift worker at night
  • Presenting blood pressure > 180/110 mm Hg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enalapril arm
Patients randomized to this group will receive equivalent dose enalapril to their current ACEI therapy and change the administration time to bedtime.
Chronotherapy with enalapril.
Other Names:
  • Vasotec
Active Comparator: Lisinopril arm
Patients randomized to this group will receive equivalent dose lisinopril to their current ACEI therapy and change the administration time to bedtime.
Chronotherapy with lisinopril
Other Names:
  • Prinivil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline nighttime blood pressure
Time Frame: Baseline and 4-6 weeks
Average blood pressure between 0000-0600.
Baseline and 4-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline night to day blood pressure ratio (dipping status)
Time Frame: Baseline and 4-6 weeks
Nighttime blood pressure (average 0000-0600)/Daytime blood pressure 0900-2100. This outcomes evaluates patients' circadian blood pressure pattern. A normal circadian blood pressure pattern shows a 10% decrease in both systolic and diastolic blood pressure at night. This will help measure the impact of chronotherapy between the 2 study agents.
Baseline and 4-6 weeks
Change from baseline 24 Hour Blood Pressure
Time Frame: Baseline and 4-6 weeks
Average blood pressure over 24 hours (0000-2359)
Baseline and 4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John D. Bucheit, Pharm D, Memorial Health University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

December 2, 2015

First Posted (Estimate)

December 7, 2015

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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