2023-503913-31-01RecruitingPhase 3
The use of sildenafil in patients with univentricular heart after Fontan operation - a pilot SINFON-POL study.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The main objective of the study is to determine whether, in adult patients with univentricular heart after Fontan operation, in stable clinical condition, without indication for cardiac catheterization, the addition of sildenafil to their existing therapy will result in improved physical performance.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 29 May 2024
- Start date
- 27 Jun 2025
- Lead sponsor
- National Institute Of Cardiology
- Diseases
- Depression
- EU CT number
- 2023-503913-31-01
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 60
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a functionally single-ventricle heart who had a Fontan operation and are clinically stable. It tests adding sildenafil to their usual treatment to see if exercise ability improves.
- Age
- Over 18 years
- Sex
- All sexes
- Disease stage
- Functionally univentricular heart after a Fontan operation (total cavo-pulmonary connection, extracardiac or intracardiac). No clinical reason for cardiac catheterization.
- Earlier treatment
- Must not have taken pulmonary arterial dilators (for example sildenafil, tadalafil, riociguat, bosentan, macitentan, ambrisentan, epoprostenol, iloprost, selixipag) in the 6 months before entering. No heart operation or vessel procedure in the last 6 months.
Main reasons for not taking part
- Pregnancy, planning pregnancy or breastfeeding
- Taking nitrates or nitric oxide products, or the strongest CYP3A4 inhibitors
- Advanced heart failure (NYHA IV) or resting oxygen saturation below 85%
- Chronic kidney disease (creatinine above 150 µmol/l) or serious liver problems
- Cannot do the exercise breathing test (ergospirometry)
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with concomitant diagnoses of: a) cardiovascular events within the last 3 months (acute coronary syndrome, sudden cardiac arrest, ventricular arrhythmias, intracranial hemorrhage, stroke), b) pulmonary embolism, c) infections, d) active bleeding complications, e) severe liver failure (Child-Pugh class C), f) active gastric and/or duodenal peptic ulcer disease, g) malignancy, h) primary muscle and nervous system disease, i) systemic connective tissue disease, j) myocarditis and/or pericarditis, k) predisposition to priapism, sclerosis of the corpus cavernosum or Peyronie's disease, l) sickle cell anemia, leukemia, or multiple myeloma, m) loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION), n) enteropathy with protein loss
- Taking products containing nitric oxide or nitrates in any form (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate, pentaerythritol tetranitrate); use in combination with the most potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir)
- Patients who were taking pulmonary arterial dilators (sildenafil, tadalafil, riociguat, bosentan, macitentan, ambrisentan, epoprostenol, iloprost, selixipag) in the 6 month period preceding study entry, regardless of the duration of therapy and route of administration (oral, intravenous, subcutaneous, inhalated)
Other illness
- Patients with a functionally univentricular heart within 6 months of their last cardiac operation or intravascular procedure
- Advanced heart failure (NYHA IV)
- Atrial arrhythmia preventing the execution/interpretation of the above-mentioned tests or a life-threatening exercise-induced arrhythmia history
Lab values
- Chronic kidney disease (creatinine > 150 µmol/l)
- Liver damage manifested by a twofold increase in transaminases above the norm
Age
- Non-use of contraception during the study - applies to women of reproductive age
Other
- Pregnancy (positive pregnancy test result), planning pregnancy, breastfeeding
- Severe central nervous system damage
- Patients unable to undergo egrospirometric examination
- Resting arterial oxygen saturation <85%
- Uncontrolled hypotension (blood pressure < 90/50 mmHg) or risk of hypotension (dehydration, systemic ventricular outflow tract obstruction, autonomic nervous system dysfunction, patients taking alpha-blockers)
Who the study is looking for
- Functionally univentricular heart
- Post-Fontan operation condition with the creation of a total cavo-pulmonary connection (TCPC) either extracardiac [extracardiac conduit] or intracardiac [lateral intra-atrial tunnel]
- No clinical indications for cardiac catheterization
- Age > 18 years
- Informed consent to participate in the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute of Cardiology | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.