Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease
Status:
Not yet recruiting
Trial end date:
2026-06-01
Target enrollment:
Participant gender:
Summary
In univentricular hearts, selective lung vasodilators such as phosphodiesterase type 5 (PDE5)
inhibitors would decrease pulmonary resistance and improve exercise tolerance. However, the
level of evidence for the use of PDE5 inhibitors in patients with a single ventricle (SV)
remains limited. the investigators present the SV-INHIBITION study rationale, design and
methods.The SV-INHIBITION trial is a nationwide multicentre, randomised, double blind,
placebo-controlled, phase III study, aiming to evaluate the efficacy of sildenafil on the
ventilatory efficiency during exercise, in teenagers and adult patients (>15 y.o.) with a SV.
Patients with pulmonary arterial hypertension (mean pulmonary arterial pressure (mPAP) > 15
mmHg and trans-pulmonary gradient > 5 mmHg) measured by cardiac catheterisation, will be
eligible. The primary outcome is the variation of the VE/VCO2 slope, measured by a
cardiopulmonary exercise test, between baseline and 6 months of treatment. A total of 50
patients are required to observe a decrease of 5 ± 5 points in the VE/VCO2 slope, with a
power of 90% power and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, 6
minute walk test, SV function, NT Pro BNP, VO2max, stroke volume, mPAP, trans-pulmonary
gradient, SF36 quality of life score, safety and acceptability. This study aims to answer the
question whether PDE5 inhibitors should be prescribed in patients with a SV. This trial has
been built focusing on the 3 levels of research defined by the WHO: disability (exercise
tolerance), deficit (SV function), and handicap (quality of life).