The use of sildenafil in patients with univentricular heart after Fontan operation - a pilot SINFON-POL study.
Key facts
- Where
- Warsaw, LengyelországSee the site
- Phase
- 3. fázis
Where in Lengyelország
- National Institute of CardiologyWarsaw, LengyelországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Institute Of Cardiology
- Trial code
- EU 2023-503913-31-01
- Record updated
- 2025. július 22.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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); 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; Chronic kidney disease (creatinine > 150 µmol/l); Liver damage manifested by a twofold increase in transaminases above the norm; Non-use of contraception during the study - applies to women of reproductive age; 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).