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
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Resistant to Conventional Therapy||Drug: Equivalent dose enalapril Drug: Equivalent dose lisinopril||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Change from baseline nighttime blood pressure [ Time Frame: Baseline and 4-6 weeks ]Average blood pressure between 0000-0600.
- 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.
- Change from baseline 24 Hour Blood Pressure [ Time Frame: Baseline and 4-6 weeks ]Average blood pressure over 24 hours (0000-2359)
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
|Contact: John D Bucheit, Pharm.D.||firstname.lastname@example.org|
|Contact: Cindy Gleit, M.D.||email@example.com|
|United States, Georgia|
|Memorial Family Medicine Center||Recruiting|
|Savannah, Georgia, United States, 31404|
|Contact: John Bucheit, Pharm.D. 312-350-8404 firstname.lastname@example.org|
|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.|
|Principal Investigator:||John D. Bucheit, Pharm D||Memorial Health University Medical Center|