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Trial record 99 of 157 for:    Idiopathic Dilated Cardiomyopathy

Effect of Aldosterone on Energy Starvation in Heart Failure

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ClinicalTrials.gov Identifier: NCT00574119
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Marvin W. Kronenberg, M.D., Vanderbilt University

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).

Condition or disease Intervention/treatment Phase
Heart Failure Nonischemic Dilated Cardiomyopathy Drug: spironolactone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Aldosterone on Energy Starvation in Heart Failure
Study Start Date : December 2007
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012


Arm Intervention/treatment
Experimental: Results with spironolactone
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.
Drug: spironolactone
spironolactone 50 mg daily for 6 months
Other Name: Aldactone




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574119


Locations
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United States, Tennessee
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Marvin W Kronenberg, MD Vanderbilt University School of Medicine
  Study Documents (Full-Text)

Documents provided by Marvin W. Kronenberg, M.D., Vanderbilt University:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marvin W. Kronenberg, M.D., Professor of Medicine and Radiology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00574119     History of Changes
Other Study ID Numbers: IRB 070824
First Posted: December 17, 2007    Key Record Dates
Results First Posted: June 18, 2019
Last Update Posted: June 18, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marvin W. Kronenberg, M.D., Vanderbilt University:
heart failure
positron emission tomography
magnetic resonance imaging
myocardial energetics
myocardial perfusion
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Failure
Starvation
Heart Diseases
Cardiovascular Diseases
Cardiomegaly
Malnutrition
Nutrition Disorders
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents