Effect of Aldosterone on Energy Starvation in Heart Failure

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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