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SINFON-POL sildenafil in Fontan patients
2023-503913-31-01Phase 3Authorised
- Sponsor
- National Institute of Cardiology
- Start
- Sep 2024
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in Cardiovascular Malformation (CVM), Fontan failure and Fontan-associated hemodynamic impairment (FAHI) comparing Sildenafil (Remidia) with Placebo (2 arms). Primary endpoint: Peak oxygen uptake (VO2max) change at 24 weeks. Planned start Sep 2024; status: authorised.
02
Drugs
sildenafil
03
Conditions
Cardiovascular Malformation (CVM)Fontan failureFontan-associated hemodynamic impairment (FAHI)
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