Trial Outcomes & Findings for Effect of Aldosterone on Energy Starvation in Heart Failure (NCT NCT00574119)

NCT ID: NCT00574119

Last Updated: 2019-06-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: baseline
• Results posted on: 2019-06-18

Participant Flow

Participant milestones

Measure	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. spironolactone: spironolactone 50 mg daily for 6 months
Overall Study STARTED	16
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	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. spironolactone: spironolactone 50 mg daily for 6 months
Overall Study Adverse Event	1
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Results With Spironolactone n=15 Participants 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
Age, Continuous	52 years n=15 Participants
Sex: Female, Male Female	5 Participants n=15 Participants
Sex: Female, Male Male	10 Participants n=15 Participants
Region of Enrollment United States	15 participants n=15 Participants

PRIMARY outcome

Timeframe: baseline

Population: 12 patients completed study

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

Outcome measures

Measure	Results With Spironolactone n=12 Participants 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
Left Ventricular Work-metabolic Index (WMI) at Baseline	7.4 (x10^6), mL x mm Hg/m^2 Interval 2.2 to 3.9

PRIMARY outcome

Timeframe: 6 months

Population: 12 patients completed study

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

Outcome measures

Measure	Results With Spironolactone n=12 Participants 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
Left Ventricular Work-metabolic Index (WMI) at 6 Months	5.4 (x10^6), mL x mm Hg/m^2 Interval 4.4 to 5.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Results With Spironolactone n=12 Participants 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
Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at Baseline	1.72 MPRI Interval 1.67 to 1.87

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Results With Spironolactone n=12 Participants 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
Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months	1.80 MPRI Interval 1.76 to 1.92

PRIMARY outcome

Timeframe: baseline and 6 months

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

Outcome measures

Measure	Results With Spironolactone n=12 Participants 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
Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging	6 msec Standard Deviation 37

SECONDARY outcome

Timeframe: baseline

6MWT assesses distance walked over 6 minutes

Outcome measures

Measure	Results With Spironolactone n=12 Participants 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
6 Minute Walk Test (6MWT) at Baseline	521 meters Interval 468.0 to 530.0

SECONDARY outcome

Timeframe: 6 months

6MWT assesses distance walked over 6 minutes

Outcome measures

Measure	Results With Spironolactone n=12 Participants 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
6 Minute Walk Test (6MWT) at 6 Months	542 meters Interval 523.0 to 604.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Results With Spironolactone n=12 Participants 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
Minnesota Living With Heart Failure Questionnaire,at Baseline	54 score on a scale Interval 26.0 to 71.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Results With Spironolactone n=12 Participants 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
Minnesota Living With Heart Failure Questionnaire.at 6 Months	22 score on a scale Interval 20.0 to 44.0

Adverse Events

Results With Spironolactone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Results With Spironolactone n=16 participants at risk 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
Respiratory, thoracic and mediastinal disorders shortness of breath	6.2% 1/16 • Number of events 1 • 6 months
Cardiac disorders pacemaker insertion	6.2% 1/16 • Number of events 1 • 6 months

Additional Information

Marvin W. Kronenberg,M.D.

Vanderbilt University School of Medicine

Phone: 615 936-7437

Email: marvin.w.kronenberg@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place