Effect of Aldosterone on Energy Starvation in Heart Failure - Full Text View

Sponsor:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00574119

Purpose

We plan to study the concept of "energy starvation" in heart failure by evaluation of patients with nonischemic dilated cardiomyopathy (heart failure with reduced heart pump function due to causes other than heart attack). We will use a combination of positron emission tomography and magnetic resonance imaging to study metabolism, anatomy, function, blood flow and efficiency, before and after 6 months' treatment with the drug spironolactone which blocks the deleterious effects of the hormone aldosterone on the myocardium (heart muscle).

Condition	Intervention	Phase
Heart Failure Nonischemic Dilated Cardiomyopathy	Drug: spironolactone	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Effect of Aldosterone on Energy Starvation in Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy Heart Failure MRI Scans

Drug Information available for: Spironolactone Aldosterone

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

left ventricular work-metabolic index, myocardial blood flow by magnetic resonance imaging, subendocardial hypoxia by magnetic resonance imaging, myocardial fibrosis by magnetic resonance imaging [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

quality of life questionnaire, 6 minute walk test [ Time Frame: 6 mnths ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	December 2007
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by positron emission tomography and magnetic resonance imaging before and after 6 months' treatment with spironolactone.	Drug: spironolactone spironolactone 50 mg daily for 6 months Other Name: Aldactone

Detailed Description:

Preliminary results showed reduced subendocardial myocardial perfusion reserve in NIDCM compared to normal subjects, and that the degree of impaired perfusion reserve was related to the oxidative metabolic rate as measured by positron emission tomography.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or older
Nonischemic dilated cardiomyopathy
Left ventricular ejection fraction 35% or less
Stable heart failure symptoms
Able to undergo both positron emission tomography and magnetic resonance imaging with gadolinium
Able to tolerate treatment with spironolactone

Exclusion Criteria:

Serum potassium >5.0
Serum creatinine >2.5
Contraindications to magnetic resonance imaging such as internal cardioverter-defibrillator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574119

Locations

United States, Tennessee
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Marvin W Kronenberg, MD

Vanderbilt University School of Medicine

More Information

No publications provided

Responsible Party:	Marvin W. Kronenberg, M.D., Vanderbilt University School of Medicine
ClinicalTrials.gov Identifier:	NCT00574119 History of Changes
Other Study ID Numbers:	IRB 070824
Study First Received:	December 13, 2007
Last Updated:	July 14, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

heart failure
positron emission tomography
magnetic resonance imaging
myocardial energetics
myocardial perfusion

Additional relevant MeSH terms:

Cardiomyopathy, Dilated
Heart Failure
Starvation
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Malnutrition
Nutrition Disorders
Spironolactone

Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012