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The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Penn State University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00964782
First received: August 21, 2009
Last updated: July 21, 2010
Last verified: July 2010
History of Changes
  Purpose

The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.


Condition Intervention Phase
Fontan Circulation
 Drug: sildenafil
Other: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • An increase in exercise capacity for patients administered sildenafil [ Time Frame: From 1 to 6 months from the date of the baseline stress test ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sildenafil
Sildenafil dosage will be 0.5mg/kg (max 20mg)
 Drug: sildenafil
oral suspension, 0.5mg/kg, taken once prior to exercise stress test
Other Name: Viagra
Placebo Comparator: placebo
Patient will receive a look-alike placebo
 Other: placebo
Patient will receive a look-alike placebo
Other Name: Composition of the placebo will be Ora-sweet and Ora-plus (1:1 ratio).

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 6-17 years
  • Male or female
  • Possess Fontan Circulation

Exclusion Criteria:

  • Severe heart failure (New York Heart Ass. functional class IV)
  • Evidence of Fontan pathway obstruction
  • History of exercise-induced severe arrhythmias
  • Pregnancy (known or suspected)
  • Orthopedic limitations that prevent ambulation on a treadmill
  • Use of nitroglycerin
  • Herbal medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964782

Contacts
Contact: Devyani Chowdhury, MD 717-531-6847 dchowdhury@hmc.psu.edu
Contact: Matthew S. Dean, MS 717-531-1847 mdean@psu.edu

Locations
United States, Pennsylvania
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Chowdhury         dchowdhury@hmc.psu.edu    
Principal Investigator: Devyani Chowdhury, MD            
Sub-Investigator: Stephen E Cyran, MD            
Sub-Investigator: Matthew S. Dean, MS            
Sponsors and Collaborators
Penn State University
Children's Miracle Network
Investigators
Principal Investigator: Devyani Chowdhury, MD Penn State Hershey Medical Center
  More Information

No publications provided

Responsible Party: Devyani Chowdhury/MD, Penn State Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00964782     History of Changes
Other Study ID Numbers: 31171
Study First Received: August 21, 2009
Last Updated: July 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Fontan
sildenafil
exercise capacity
Patients with Fontan Circulation

Additional relevant MeSH terms:
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013