Brief Title
Effect of Aldosterone on Energy Starvation in Heart Failure
Official Title
Effect of Aldosterone on Energy Starvation in Heart Failure
Brief Summary
We plan to study the concept of "energy starvation" in heart failure by evaluation of
patients with nonischemic dilated cardiomyopathy (NIDCM) (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).
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Left Ventricular Work-metabolic Index (WMI) at Baseline
Secondary Outcome
6 Minute Walk Test (6MWT) at Baseline
Condition
Heart Failure
Intervention
spironolactone
Study Arms / Comparison Groups
Results with spironolactone
Description: patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by 11C acetate positron emission tomography and magnetic resonance imaging using vasodilator and gadolinium to judge myocardial blood flow, before and after 6 months' treatment with spironolactone.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
16
Start Date
December 2007
Completion Date
July 2012
Primary Completion Date
July 2012
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Marvin W Kronenberg, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00574119
Organization ID
IRB 070824
Responsible Party
Principal Investigator
Study Sponsor
Vanderbilt University
Study Sponsor
Marvin W Kronenberg, MD, Principal Investigator, Vanderbilt University School of Medicine
Verification Date
May 2019