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A Study of the Effects of Eplerenone and Amlodipine on Blood Pressure and Basal Metabolic Rate in Obese Hypertensives

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ClinicalTrials.gov Identifier: NCT00825188
Recruitment Status : Terminated (funding to complete was inadequate)
First Posted : January 19, 2009
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Marion Wofford, University of Mississippi Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Hypertension Drug: eplerenone, amlodipine Drug: eplerenone Drug: amlodipine Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : January 2009
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Basal metabolic rate [ Time Frame: Pre and post treatment ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00825188


Locations
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United States, Mississippi
The University of Mississippi Clinical Research Program
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
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Principal Investigator: Marion Wofford, MD University of Mississippi Medical Center
More Information
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Responsible Party: Marion Wofford, Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00825188     History of Changes
Other Study ID Numbers: 2008-0035
First Posted: January 19, 2009    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: March 2014
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Eplerenone
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents