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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Heart Failure
Nonischemic Dilated Cardiomyopathy
Intervention Drug: spironolactone
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Results With Spironolactone
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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.

spironolactone: spironolactone 50 mg daily for 6 months

Period Title: Overall Study
Started 16
Completed 12
Not Completed 4
Reason Not Completed
Adverse Event             1
Protocol Violation             1
Withdrawal by Subject             1
Physician Decision             1
Arm/Group Title Results With Spironolactone
Hide Arm/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.

spironolactone: spironolactone 50 mg daily for 6 months

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
one patient excluded prior to drug administration due to normal LV function.
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 15 participants
52
(45 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
5
  33.3%
Male
10
  66.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Left Ventricular Work-metabolic Index (WMI) at Baseline
Hide Description WMI=[left ventricular stroke work/decay rate of 11C-acetate]
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
12 patients completed study
Arm/Group Title Results With Spironolactone
Hide Arm/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.

spironolactone: spironolactone 50 mg daily for 6 months

Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: (x10^6), mL x mm Hg/m^2
7.4
(2.2 to 3.9)
2.Primary Outcome
Title Left Ventricular Work-metabolic Index (WMI) at 6 Months
Hide Description WMI=[left ventricular stroke work/decay rate of 11C-acetate]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
12 patients completed study
Arm/Group Title Results With Spironolactone
Hide Arm/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.

spironolactone: spironolactone 50 mg daily for 6 months

Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: (x10^6), mL x mm Hg/m^2
5.4
(4.4 to 5.9)
3.Primary Outcome
Title Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at Baseline
Hide Description 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.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Results With Spironolactone
Hide Arm/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.

spironolactone: spironolactone 50 mg daily for 6 months

Overall Number of Participants Analyzed 12
Mean (Inter-Quartile Range)
Unit of Measure: MPRI
1.72
(1.67 to 1.87)
4.Primary Outcome
Title Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Results With Spironolactone
Hide Arm/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.

spironolactone: spironolactone 50 mg daily for 6 months

Overall Number of Participants Analyzed 12
Mean (Inter-Quartile Range)
Unit of Measure: MPRI
1.80
(1.76 to 1.92)
5.Primary Outcome
Title Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging
Hide Description T1=left ventricular relaxation rate on magnetic resonance imaging, which is correlated with interstitial fibrosis.
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Results With Spironolactone
Hide Arm/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.

spironolactone: spironolactone 50 mg daily for 6 months

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: msec
6  (37)
6.Secondary Outcome
Title 6 Minute Walk Test (6MWT) at Baseline
Hide Description 6MWT assesses distance walked over 6 minutes
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Results With Spironolactone
Hide Arm/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.

spironolactone: spironolactone 50 mg daily for 6 months

Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: meters
521
(468 to 530)
7.Secondary Outcome
Title 6 Minute Walk Test (6MWT) at 6 Months
Hide Description 6MWT assesses distance walked over 6 minutes
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Results With Spironolactone
Hide Arm/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.

spironolactone: spironolactone 50 mg daily for 6 months

Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: meters
542
(523 to 604)
8.Secondary Outcome
Title Minnesota Living With Heart Failure Questionnaire,at Baseline
Hide Description 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.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Results With Spironolactone
Hide Arm/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.

spironolactone: spironolactone 50 mg daily for 6 months

Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
54
(26 to 71)
9.Secondary Outcome
Title Minnesota Living With Heart Failure Questionnaire.at 6 Months
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Results With Spironolactone
Hide Arm/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.

spironolactone: spironolactone 50 mg daily for 6 months

Overall Number of Participants Analyzed 12
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
22
(20 to 44)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Results With Spironolactone
Hide Arm/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.

spironolactone: spironolactone 50 mg daily for 6 months

All-Cause Mortality
Results With Spironolactone
Affected / at Risk (%)
Total   0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Results With Spironolactone
Affected / at Risk (%) # Events
Total   0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Results With Spironolactone
Affected / at Risk (%) # Events
Total   2/16 (12.50%)    
Cardiac disorders   
pacemaker insertion  [1]  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
shortness of breath  [2]  1/16 (6.25%)  1
Indicates events were collected by systematic assessment
[1]
pacemaker insertion by personal physician
[2]
shortness of breath during test
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marvin W. Kronenberg,M.D.
Organization: Vanderbilt University School of Medicine
Phone: 615 936-7437
EMail: marvin.w.kronenberg@vumc.org
Layout table for additonal information
Responsible Party: Marvin W. Kronenberg, M.D., Vanderbilt University
ClinicalTrials.gov Identifier: NCT00574119     History of Changes
Other Study ID Numbers: IRB 070824
First Submitted: December 13, 2007
First Posted: December 17, 2007
Results First Submitted: May 8, 2019
Results First Posted: June 18, 2019
Last Update Posted: June 18, 2019