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Clinical Trials/EUCTR2007-002688-28-IT
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

Sponsor
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

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