Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients
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|ClinicalTrials.gov Identifier: NCT01291069|
Recruitment Status : Completed
First Posted : February 7, 2011
Last Update Posted : April 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Single Ventricle||Drug: Tadalafil Citrate Drug: Sugar pill||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
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
- 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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291069
|United States, Utah|
|Primary Childrens Medical Center|
|Salt lake City, Utah, United States, 84113|
|Principal Investigator:||Shaji C. Menon, MD||University of Utah|