Phase 4
Completed N=16
Effect of Aldosterone on Energy Starvation in Heart Failure
Heart Failure · Nonischemic Dilated Cardiomyopathy
Source: ClinicalTrials.gov NCT00574119 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Left Ventricular Work-metabolic Index (WMI) at Baseline — 7.4 (x10^6), mL x mm Hg/m^2
◆ Published Evidence
Emerging
19citations · ~1 / year
Impairment of subendocardial perfusion reserve and oxidative metabolism in nonischemic dilated cardiomyopathy.
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).
Linked Publications (5)
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Impairment of subendocardial perfusion reserve and oxidative metabolism in nonischemic dilated cardiomyopathy.
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Antifailure therapy including spironolactone improves left ventricular energy supply-demand relations in nonischemic dilated cardiomyopathy.
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Modification of ventriculo-arterial coupling by spironolactone in nonischemic dilated cardiomyopathy.
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High reproducibility of adenosine stress cardiac MR myocardial perfusion imaging in patients with non-ischaemic dilated cardiomyopathy.
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Timing of Left Ventricular Remodeling in Nonischemic Dilated Cardiomyopathy.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.