EUCTR2007-002688-28-ITActive, not recruitingNot Applicable
Pilot study on the short-term effects of Sildenafil on hemodynamic response to exercise and exercise capacity in Fontan patients - ND
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 sitesStarted: May 29, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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