- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02623036
The Use of Ambulatory Blood Pressure Monitors to Assess Angiotensin Converting Enzyme Inhibitors
The Use of Ambulatory Blood Pressure Monitors to Assess Angiotensin Converting Enzyme Inhibitors in Resistant Hypertension
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: John D Bucheit, Pharm.D.
- Phone Number: 912-350-8404
- Email: bucheit_jd@mercer.edu
Study Contact Backup
- Name: Cindy Gleit, M.D.
- Phone Number: 912-350-8404
- Email: cindygleit@memorialhealth.com
Study Locations
-
-
Georgia
-
Savannah, Georgia, United States, 31404
- Recruiting
- Memorial Family Medicine Center
-
Contact:
- John Bucheit, Pharm.D.
- Phone Number: 312-350-8404
- Email: 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.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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
Investigators
- Principal Investigator: John D. Bucheit, Pharm D, Memorial Health University Medical Center
Publications and helpful links
General Publications
- Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
- Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM; American Heart Association Professional Education Committee. Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation. 2008 Jun 24;117(25):e510-26. doi: 10.1161/CIRCULATIONAHA.108.189141.
- Weisser K, Schloos J, Lehmann K, Dusing R, Vetter H, Mutschler E. Pharmacokinetics and converting enzyme inhibition after morning and evening administration of oral enalapril to healthy subjects. Eur J Clin Pharmacol. 1991;40(1):95-9. doi: 10.1007/BF00315146.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHUMC 2015.10.01
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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