Effect of Aldosterone on Energy Starvation in Heart Failure (NCT00574119) | Clinical Trial Compass
CompletedPhase 4
Effect of Aldosterone on Energy Starvation in Heart Failure
United States16 participantsStarted 2007-12
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Left Ventricular Work-metabolic Index (WMI) at Baseline
Timeframe: baseline
2
Left Ventricular Work-metabolic Index (WMI) at 6 Months
Timeframe: 6 months
3
Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at Baseline
Timeframe: baseline
4
Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months
Timeframe: 6 months
5
Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging