Effect of Aldosterone on Energy Starvation in Heart Failure

Vanderbilt University

Status and phase: Completed; Phase 4

Conditions: Nonischemic Dilated Cardiomyopathy; Heart Failure

Treatments: Drug: spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT00574119

IRB 070824

Details and patient eligibility

About

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).

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Results with spironolactone

Experimental group

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.

Treatment:

Drug: spironolactone