Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients
Recruitment status was Recruiting
This pilot study is aimed at assessing the short-term effects of Tadalafil on the hemodynamic response to exercise and exercise capacity in patients with Fontan circulation. Data regarding effect size and drug tolerability will be used in the design of a randomized multicenter trial. The long-term goal of this investigation is to systematically evaluate the effect of tadalafil therapy on exercise performance, quality of life, and delay of functional deterioration in patients with single ventricle physiology.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients|
- To compare the effects of Tadalafil versus placebo on exercise capacity (maximal oxygen consumption: VO2 max) for patients (8-35 years)with the Fontan circulation (8 -18 years). [ Time Frame: 2 years ] [ Designated as safety issue: No ]Short-term treatment with Tadalafil will augment cardiac output and improve exercise capacity (maximal oxygen consumption: VO2 max) in patients with the Fontan circulation. Primary outcome variables include the change in peak exercise capacity (VO2 max), using cycle ergometry after one week of tadalafil therapy
- To evaluate the adverse effects of Tdalafil in patients (8-35 years)with the Fontan circulation and compare with the placebo group. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Hypothesis: Short-term treatment with Tadalafil will be well tolerated by children with the Fontan circulation. Adverse effect forms will be used to compare the side effects between Tadalafil and treatment group.
|Study Start Date:||September 2011|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Tadalafil Citrate
The study subjects will be given Tadalfil citrate, encapsulated, 0.8-1 mg/kg/day in 1 dose orally. Max dose 40 mg. All patients will receive either study drug or placebo for a total of 20 days.
Drug: Tadalafil Citrate
If allocated to the treatment arm, the patient will be given tadalfil citrate, 0.8-1 mg/kg/day in 1 daily dose. Maximum dose 40 mg. All patients will receive either study drug or placebo for a total of 20 days.
Other Name: Cialis
Placebo Comparator: Sugar pill
If allocated to the placebo arm, the child will be given a similar appearing medication; the placebo will be a sugar pill. All patients will receive either study drug or placebo for a total of 20 days.
Drug: Sugar pill
If allocated to the placebo arm, the child will be given a similar appearing medication; the placebo will be a mixture of Ora-Sweet® and Ora-Plus® in a 1:1 ratio. All patients will receive drug for 20 days
Other Name: Ora sweet
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291069
|Contact: Linda M. Lambert, APRN||801 662 firstname.lastname@example.org|
|United States, Utah|
|Primary Childrens Medical Center||Recruiting|
|Salt lake City, Utah, United States, 84113|
|Contact: Shaji C. Menon, MD 801-662-5400 email@example.com|
|Contact: Linda Lambert, APRN 801 662 5573 firstname.lastname@example.org|
|Principal Investigator: Shaji C. Menon, MD|
|Principal Investigator:||Shaji C. Menon, MD||University of Utah|