CompletedPhase 2

Sildenafil After the Fontan Operation

28 participantsStarted 2007-12

Plain-language summary

In this study, the investigators will evaluate the effect of sildenafil on exercise tolerance in patients with a single cardiac ventricle who have undergone the Fontan operation. The investigators will also evaluate echocardiographic measures of ventricular function and measure quality of life changes using two validated quality of life measures. The hypothesis is that sildenafil will result in increased exercise tolerance in patients who have had the Fontan operation as compared to placebo.

Who can participate

Age range

8 Years – 40 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: * 8 years of age or older * All participants must have had Fontan completion Exclusion Criteria: * Height less than 132 cm * Unable to participate in exercise testing due to medical restrictions or physical limitations * Fontan baffle obstruction or single lung physiology * Coarctation of the aorta or neo-aorta (BP gradient \> 20 mmHg) * Severe ventricular dysfunction assessed qualitatively by echocardiography * Severe atrioventricular valvar regurgitation assessed qualitatively by echocardiography * Presence of electronic pacemaker * History of treatment with sildenafil in the six weeks prior to enrollment in study * Patients with severe renal impairment * Patients with severe hepatic impairment * Patients taking medications that inhibit or induce Cytochrome P450 3A4 (CYP3A4) (including grapefruit juice and St. John's Wort) * Patients taking alpha-blockers and nitrates * Parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

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

Change From Baseline in Mean Oxygen Consumption (mL/kg/Min) at 6 Weeks

Timeframe: Baseline and 6 Weeks

Trial details

NCT IDNCT00507819

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-04

Results submitted2011-02-09

View on ClinicalTrials.gov More Hypoplastic Left Heart Syndrome trials