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

• Conditions: congenital heart disease; MedDRA version: 6.1Level: PTClassification code 10045545

• Registration Number: EUCTR2007-002688-28-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified