Phase 4
N=16
Effect of Aldosterone on Energy Starvation in Heart Failure
Heart Failure · Nonischemic Dilated Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT00574119 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Left Ventricular Work-metabolic Index (WMI) at Baseline — 7.4 (x10^6), mL x mm Hg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- spironolactone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Ventricular Work-metabolic Index (WMI) at Baseline |
7.4 | — |
| PRIMARY Left Ventricular Work-metabolic Index (WMI) at 6 Months |
5.4 | — |
| PRIMARY Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at Baseline |
1.72 | — |
| PRIMARY Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months |
1.80 | — |
| PRIMARY Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging |
6 | — |
| SECONDARY 6 Minute Walk Test (6MWT) at Baseline |
521 | — |
| SECONDARY 6 Minute Walk Test (6MWT) at 6 Months |
542 | — |
| SECONDARY Minnesota Living With Heart Failure Questionnaire,at Baseline |
54 | — |
| SECONDARY Minnesota Living With Heart Failure Questionnaire.at 6 Months |
22 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT00574119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.