TerminatedPhase 4

The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease

Stopped: Investigator left institution

United States26 participantsStarted 2013-08

Plain-language summary

Hypothesis: By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias decreased through decreases in myocardial fibrosis. Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6 minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months without therapy, after 6 months on therapy, then finally after 12 months of eplerenone therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12 months on therapy. Patients will be randomly assigned to drug free period up front versus at the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for monitoring.

Who can participate

Age range

18 Years – 80 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: * Established diagnosis of tetralogy of Fallot, transposition of the great vessels with a systemic right ventricle, or Fontan type palliation * Patient followed regularly at Washington University-affiliated institution * If female, willing to use 2 forms of contraception including one barrier method during protocol Exclusion Criteria: * GFR \<30 ml/min * Potassium \>5.0 mmol/L * Unable or unwilling to comply with study protocol * Use of potassium sparing diuretics * Use of an aldosterone blocker currently or previously * Known intolerance of eplerenone or aldosterone blockade * Pregnant, breastfeeding, or actively trying to get pregnant

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

Procollagen N-terminal Peptide 1

Timeframe: Baseline, 6 months and 12 months from eplerenone administration

Procollagen III N-Terminal Peptide

Timeframe: Baseline, 6 months and 12 months from eplerenone administration

Galectin 3

Timeframe: Baseline, 6 months and 12 months from eplerenone administration

Trial details

NCT IDNCT01971593

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03

Results submitted2018-01-25

View on ClinicalTrials.gov More Tetralogy of Fallot trials

Plain-language summary

Who can participate

Age range

18 Years – 80 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.

What they're measuring

Procollagen N-terminal Peptide 1

Timeframe: Baseline, 6 months and 12 months from eplerenone administration

Procollagen III N-Terminal Peptide

Timeframe: Baseline, 6 months and 12 months from eplerenone administration

Galectin 3

Timeframe: Baseline, 6 months and 12 months from eplerenone administration