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A Study of the Effects of Eplerenone and Amlodipine on Blood Pressure and Basal Metabolic Rate in Obese Hypertensives
This study is currently recruiting participants.
Verified July 2010 by University of Mississippi Medical Center

First Received on January 16, 2009.   Last Updated on July 14, 2010   History of Changes
Sponsor: University of Mississippi Medical Center
Information provided by: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00825188
  Purpose

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.


Condition Intervention
Obesity
Hypertension
 Drug: eplerenone, amlodipine
Drug: eplerenone
Drug: amlodipine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure High Blood Pressure Obesity
Drug Information available for: Amlodipine Amlodipine besylate
U.S. FDA Resources

Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Basal metabolic rate [ Time Frame: Pre and post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: eplerenone Drug: eplerenone, amlodipine
Eplerenone 25mm qd versus amlodipine 5mg qd x 4weeks the Eplerenone 50mg qd versus amlodipine 10mg qd x 4weeks
Other Names:
  • Inspra
  • Norvasc
Drug: eplerenone
Eplerenone 25-50mg daily x 8 weeks
Other Name: Inspra
Drug: eplerenone
eplerenone 25- 50 mg daily for 8 weeks
Other Names:
  • Inspra
  • Norvasc
Drug: amlodipine
amlodipine 5-10mg daily for 8 weeks
Other Name: Norvasc
Active Comparator: amlodipine
Amlodipine 5-10mg daily times 8 weeks
 Drug: eplerenone, amlodipine
Eplerenone 25mm qd versus amlodipine 5mg qd x 4weeks the Eplerenone 50mg qd versus amlodipine 10mg qd x 4weeks
Other Names:
  • Inspra
  • Norvasc
Drug: eplerenone
eplerenone 25- 50 mg daily for 8 weeks
Other Names:
  • Inspra
  • Norvasc
Drug: amlodipine
amlodipine 5-10mg daily for 8 weeks
Other Name: Norvasc

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825188

Contacts
Contact: Catherine M Adair, RN, CCRC 601-815-1338 cadair@medicine.umsmed.edu

Locations
United States, Mississippi
The University of Mississippi Clinical Research Program Recruiting
Jackson, Mississippi, United States, 39216
Contact: Catherine M Adair, RN, CCRC     601-815-1338     cadair@medicine.umsmed.edu    
Principal Investigator: Marion R Wofford, MD, MPH            
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: Marion Wofford, MD University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: Marion Wofford, MD, MPH, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00825188     History of Changes
Other Study ID Numbers: 2008-0035
Study First Received: January 16, 2009
Last Updated: July 14, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Obesity
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Amlodipine
Eplerenone
Spironolactone
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on February 09, 2012



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