A Study of the Effects of Eplerenone and Amlodipine on Blood Pressure and Basal Metabolic Rate in Obese Hypertensives
Information source: University of Mississippi Medical Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Hypertension
Intervention: eplerenone, amlodipine (Drug); eplerenone (Drug); eplerenone (Drug); amlodipine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Mississippi Medical Center Official(s) and/or principal investigator(s):
Marion Wofford, MD, Principal Investigator, Affiliation: University of Mississippi Medical Center
Overall contact:
Catherine M Adair, RN, CCRC, Phone: 601-815-1338, Email: cadair@umc.edu
Summary
Obesity and hypertension are independent risks for congestive heart failure (CHF) and
chronic kidney disease. In obesity induced hypertension, the most common cause of human
essential hypertension, the potential importance of mineralocorticoid receptor blockade has
not been widely investigated. We propose to test the hypothesis that eplerenone reduces
metabolic demand, improves cardiac function and attenuates glomerular hyperfiltration and
microalbuminuria in obese patients. Our specific aims are to assess changes in basal
metabolic rate, cardiac and renal function in obese hypertensive subjects treated with
eplerenone compared to amlodipine.
Clinical Details
Official title: Investigation of Reduction of Blood Pressure and Metabolic Rate in Obese Hypertensive Patients Using Eplerenone: Implications for Treatment of Hypertension and Heart Failure
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Basal metabolic rate
Detailed description:
The proposed trial will utilize an open label study design. Patients with hypertension and
obesity will be recruited. After a 3-week washout period for patients currently on
antihypertensive medication, eligible participants will be assigned to receive 25 mg of
eplerenone or 5 mg of amlodipine. After a 4 week period on medication, drug will be advanced
to 50 mg of eplerenone or 10 mg of amlodipine for an additional 4 weeks.
Protocol Synopsis:
1. Recruit 20 study participants with a systolic blood pressure (SBP) between 140 and 160
mmHg and/or a diastolic blood pressure between 90 and 100 mmHg who also have a body
mass index > 30-45. If participants are on antihypertensive treatment, they will
undergo a 3-week washout period. The study participants will be identified in the
Division of Hypertension.
2. Assign study participants to receive 25 mg of eplerenone or 5 mg of amlodipine per day
for 4 weeks. Up-titration to eplerenone 50 mg and amlodipine 10 mg for an additional 4
weeks.
3. Obtain basal metabolic rate, cardiac output and other indices of cardiac performance,
cognitive abilities, and rating of depression and anxiety symptoms at baseline and
after 8 weeks of treatment.
4. Obtain blood pressure measures at all visits.
5. Obtain mood ratings at all visits.
6. Compare basal metabolic rate, cardiac output and other indices of cardiac performance
between treatment groups.
7. Compare difference in SBP and DBP between treatment groups.
8. Compare differences in plasma insulin, serum electrolytes, plasma renin activity,
cortisol and aldosterone concentrations, urinary albumin excretion, and glomerular
filtration rate between treatment groups.
9. Compare mood rating as well as symptoms of depression and anxiety between treatment
groups.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Systolic blood pressure (SBP) between 140 and 160 mmHg and/or a diastolic blood
pressure between 90 and 100 mmHg who also have a body mass index > 30-45.
- Women must be post menopausal
Exclusion Criteria:
- Women of child bearing potential
- BMI less than 30 or greater than 45
- A creatinine > 1. 8 for females and > 2. 0 for males
- Type 1 or type 2 diabetes
- Current evidence of alcohol or drug abuse problems
Locations and Contacts
Catherine M Adair, RN, CCRC, Phone: 601-815-1338, Email: cadair@umc.edu
The University of Mississippi Clinical Research Program, Jackson, Mississippi 39216, United States; Recruiting
Catherine M Adair, RN, CCRC, Phone: 601-815-1338, Email: cadair@umc.edu
Marion R Wofford, MD, MPH, Principal Investigator
Additional Information
Starting date: January 2009
Last updated: April 10, 2012
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