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

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ClinicalTrials.gov Identifier: NCT02623036
Recruitment Status : Unknown
Verified May 2017 by John Bucheit, Pharm.D.,BCACP, CDE, Memorial Health University Medical Center.
Recruitment status was:  Recruiting
First Posted : December 7, 2015
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
John Bucheit, Pharm.D.,BCACP, CDE, Memorial Health University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension, Resistant to Conventional Therapy Drug: Equivalent dose enalapril Drug: Equivalent dose lisinopril Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Ambulatory Blood Pressure Monitors to Assess Angiotensin Converting Enzyme Inhibitors in Resistant Hypertension
Study Start Date : November 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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.
Drug: Equivalent dose enalapril
Chronotherapy with enalapril.
Other Name: 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.
Drug: Equivalent dose lisinopril
Chronotherapy with lisinopril
Other Name: Prinivil




Primary Outcome Measures :
  1. Change from baseline nighttime blood pressure [ Time Frame: Baseline and 4-6 weeks ]
    Average blood pressure between 0000-0600.


Secondary Outcome Measures :
  1. 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.

  2. Change from baseline 24 Hour Blood Pressure [ Time Frame: Baseline and 4-6 weeks ]
    Average blood pressure over 24 hours (0000-2359)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623036


Contacts
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Contact: John D Bucheit, Pharm.D. 912-350-8404 bucheit_jd@mercer.edu
Contact: Cindy Gleit, M.D. 912-350-8404 cindygleit@memorialhealth.com

Locations
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United States, Georgia
Memorial Family Medicine Center Recruiting
Savannah, Georgia, United States, 31404
Contact: John Bucheit, Pharm.D.    312-350-8404    bucheit_jd@mercer.edu   
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.         
Sponsors and Collaborators
Memorial Health University Medical Center
Investigators
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Principal Investigator: John D. Bucheit, Pharm D Memorial Health University Medical Center
Publications of Results:
Other Publications:
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Responsible Party: John Bucheit, Pharm.D.,BCACP, CDE, Principal Investigator, Memorial Health University Medical Center
ClinicalTrials.gov Identifier: NCT02623036    
Other Study ID Numbers: MHUMC 2015.10.01
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Keywords provided by John Bucheit, Pharm.D.,BCACP, CDE, Memorial Health University Medical Center:
chronotherapy
angiotensin converting enzyme inhibitors
ambulatory blood pressure monitoring
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Enalapril
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs