NCT03997097: VU-INHIB

Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease

Withdrawn Phase 3 Last updated 15 May 2023

What this trial tests

Phase 3 trial testing Sildenafil in Single-ventricle. Withdrawn.

Timeline

1 June 2023

Primary endpoint
1 June 2026

1 June 2028

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Start date	1 June 2023
Primary completion	1 June 2026
Estimated completion	1 June 2028

Drugs / interventions tested

• Sildenafil (sildenafil) — full drug profile →
• Placebos — full drug profile →

Conditions studied

• Single-ventricle — all drugs for Single-ventricle →
• Pulmonary Hypertension — all drugs for Pulmonary Hypertension →
• Univentricular Heart — all drugs for Univentricular Heart →

Sponsor

University Hospital, Montpellier

Who can join

Adults 15 to 80, any sex, with Single-ventricle or Pulmonary Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of phosphodiesterase type 5 inhibitors in univentricular congenital heart disease: the SV-INHIBITION study design.
   Amedro P, Gavotto A, Abassi H, Picot MC, et al · · 2020 · cited 10× · PMID 32147955 · DOI 10.1002/ehf2.12630
2. Focused Update on Pulmonary Hypertension in Children-Selected Topics of Interest for the Adult Cardiologist.
   Albinni S, Marx M, Lang IM. · · 2020 · PMID 32825190 · DOI 10.3390/medicina56090420