Back to resultsEffect of Aldosterone on Energy Starvation in Heart Failure
Primary Purpose
Heart Failure, Nonischemic Dilated Cardiomyopathy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
spironolactone
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring heart failure, positron emission tomography, magnetic resonance imaging, myocardial energetics, myocardial perfusion
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.
Sites / Locations
- Vanderbilt Heart and Vascular Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Results with spironolactone
Arm 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.
Outcomes
Primary Outcome Measures
Left Ventricular Work-metabolic Index (WMI) at Baseline
WMI=[left ventricular stroke work/decay rate of 11C-acetate]
Left Ventricular Work-metabolic Index (WMI) at 6 Months
WMI=[left ventricular stroke work/decay rate of 11C-acetate]
Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at 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.
Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 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.
Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging
T1=left ventricular relaxation rate on magnetic resonance imaging, which is correlated with interstitial fibrosis.
Secondary Outcome Measures
6 Minute Walk Test (6MWT) at Baseline
6MWT assesses distance walked over 6 minutes
6 Minute Walk Test (6MWT) at 6 Months
6MWT assesses distance walked over 6 minutes
Minnesota Living With Heart Failure Questionnaire,at 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.
Minnesota Living With Heart Failure Questionnaire.at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00574119
Brief Title
Effect of Aldosterone on Energy Starvation in Heart Failure
Official Title
Effect of Aldosterone on Energy Starvation in Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Nonischemic Dilated Cardiomyopathy
Keywords
heart failure, positron emission tomography, magnetic resonance imaging, myocardial energetics, myocardial perfusion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Results with spironolactone
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
spironolactone
Other Intervention Name(s)
Aldactone
Intervention Description
spironolactone 50 mg daily for 6 months
Primary Outcome Measure Information:
Title
Left Ventricular Work-metabolic Index (WMI) at Baseline
Description
WMI=[left ventricular stroke work/decay rate of 11C-acetate]
Time Frame
baseline
Title
Left Ventricular Work-metabolic Index (WMI) at 6 Months
Description
WMI=[left ventricular stroke work/decay rate of 11C-acetate]
Time Frame
6 months
Title
Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at Baseline
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
Title
Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months
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
Title
Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging
Description
T1=left ventricular relaxation rate on magnetic resonance imaging, which is correlated with interstitial fibrosis.
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
6 Minute Walk Test (6MWT) at Baseline
Description
6MWT assesses distance walked over 6 minutes
Time Frame
baseline
Title
6 Minute Walk Test (6MWT) at 6 Months
Description
6MWT assesses distance walked over 6 minutes
Time Frame
6 months
Title
Minnesota Living With Heart Failure Questionnaire,at Baseline
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
Title
Minnesota Living With Heart Failure Questionnaire.at 6 Months
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marvin W Kronenberg, MD
Organizational Affiliation
Vanderbilt University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt Heart and Vascular Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33403831
Citation
Lawson MA, Hansen DE, Gupta DK, Bell SP, Adkisson DW, Mallugari RR, Sawyer DB, Ooi H, Kronenberg MW. Modification of ventriculo-arterial coupling by spironolactone in nonischemic dilated cardiomyopathy. ESC Heart Fail. 2021 Apr;8(2):1156-1166. doi: 10.1002/ehf2.13161. Epub 2021 Jan 5.
Results Reference
derived
PubMed Identifier
30286821
Citation
Bradham WS, Bell SP, Huang S, Harrell FE Jr, Adkisson DW, Lawson MA, Sawyer DB, Ooi H, Kronenberg MW. Timing of Left Ventricular Remodeling in Nonischemic Dilated Cardiomyopathy. Am J Med Sci. 2018 Sep;356(3):262-267. doi: 10.1016/j.amjms.2018.06.003. Epub 2018 Jun 8.
Results Reference
derived
PubMed Identifier
25515841
Citation
Lawson MA, Bell SP, Adkisson DW, Wang L, Ooi H, Sawyer DB, Kronenberg MW. High reproducibility of adenosine stress cardiac MR myocardial perfusion imaging in patients with non-ischaemic dilated cardiomyopathy. BMJ Open. 2014 Dec 16;4(12):e005984. doi: 10.1136/bmjopen-2014-005984.
Results Reference
derived
PubMed Identifier
25164945
Citation
Bell SP, Adkisson DW, Lawson MA, Wang L, Ooi H, Sawyer DB, Kronenberg MW. Antifailure therapy including spironolactone improves left ventricular energy supply-demand relations in nonischemic dilated cardiomyopathy. J Am Heart Assoc. 2014 Aug 27;3(4):e000883. doi: 10.1161/JAHA.114.000883.
Results Reference
derived
PubMed Identifier
24331202
Citation
Bell SP, Adkisson DW, Ooi H, Sawyer DB, Lawson MA, Kronenberg MW. Impairment of subendocardial perfusion reserve and oxidative metabolism in nonischemic dilated cardiomyopathy. J Card Fail. 2013 Dec;19(12):802-10. doi: 10.1016/j.cardfail.2013.10.010. Epub 2013 Oct 29.
Results Reference
derived
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Effect of Aldosterone on Energy Starvation in Heart Failure
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