Pilot study on the short-term effects of Sildenafil on hemodynamic response to exercise and exercise capacity in Fontan patients - ND

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002688-28-IT

Enrollment

Registered

2007-05-29

Start date

2007-05-22

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital heart disease MedDRA version: 6.1 Level: PT Classification code 10045545

Interventions

Trade Name: VIAGRA*4CPR 50MG Product Name: sildenafil Pharmaceutical Form: Tablet INN or Proposed INN: Sildenafil Current Sponsor code: 66/2007/U/Sper Concentration unit: mg milligram(s) Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Fontan operation - Stable clinical condition in the preceding 3 months - Both male and female gender patients will be enrolled Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Active listing for heart transplantation - Severe heart failure symptoms (NYHA functional class IV) - Arterial blood saturation < 85% at rest - Known liver or kidney dysfunction - Lactose intolerance - Hypotension (systolic blood pressure at rest < 90 mmHg) - Severe arrhythmias (ventricular tachycardia or hemodynamically instable atrial arrhythmia), symptomatic hypotension (systolic blood pressure < 90 mmHg with symptoms) or severe discomfort during effort documented at a previous exercise study. - Fontan operation completed during the preceding 6 months or any kind of severe illness in the preceding 3 months. - Asthma or inability to exercise - Pregnancy (known or suspected) - Body weight <=50 Kg

Design outcomes

Primary

Measure	Time frame
Main Objective: The present study sought to assess the short-term effects of sildenafil on cardiopulmonary function and on the response to exercise of pulmonary blood flow and cardiac output in Fontan patients;Secondary Objective: increase of exercise time increase in basal oxygen saturation and at the top of exercise;Primary end point(s): Increase in oxygen conusmption Increase in cardiac output	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026