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Completed

NCT Number: NCT00574119

Effect of Aldosterone on Energy Starvation in Heart Failure

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Nonischemic Dilated Cardiomyopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vanderbilt Heart and Vascular Institute

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spironolactone

Drug

spironolactone 50 mg daily for 6 months

Other names: Aldactone

Primary outcomes

  1. Left Ventricular Work-metabolic Index (WMI) at Baseline

    Time frame: baseline

    WMI=[left ventricular stroke work/decay rate of 11C-acetate]

  2. Left Ventricular Work-metabolic Index (WMI) at 6 Months

    Time frame: 6 months

    WMI=[left ventricular stroke work/decay rate of 11C-acetate]

  3. Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at Baseline

    Time frame: baseline

    MPRI =calculated myocardial perfusion reserve index based on Gadolinium accretion into myocardium. MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope.

  4. Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months

    Time frame: 6 months

    MPRI =calculated myocardial perfusion reserve index based on Gadolinium accretion into myocardium. MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope.

  5. Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging

    Time frame: baseline and 6 months

    T1=left ventricular relaxation rate on magnetic resonance imaging, which is correlated with interstitial fibrosis.

Secondary outcomes

  1. 6 Minute Walk Test (6MWT) at Baseline

    Time frame: baseline

    6MWT assesses distance walked over 6 minutes

  2. 6 Minute Walk Test (6MWT) at 6 Months

    Time frame: 6 months

    6MWT assesses distance walked over 6 minutes

  3. Minnesota Living With Heart Failure Questionnaire,at Baseline

    Time frame: baseline

    The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each question is scored from 0 (none or not applicable) to 5 (very much). Total scores range from 0-105. Low scores indicate less adverse impact, while higher scores reflect more adverse impact of heart failure.

  4. Minnesota Living With Heart Failure Questionnaire.at 6 Months

    Time frame: 6 months

    The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each question is scored from 0 (none or not applicable) to 5 (very much). Total scores range from 0-105. Low scores indicate less adverse impact, while higher scores reflect more adverse impact of heart failure.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Dec 17, 2007
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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