Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients

This study is currently recruiting participants.
Verified June 2012 by University of Utah
Sponsor:
Information provided by (Responsible Party):
Shaji Menon, University of Utah
ClinicalTrials.gov Identifier:
NCT01291069
First received: February 4, 2011
Last updated: June 6, 2012
Last verified: June 2012

February 4, 2011
June 6, 2012
September 2011
February 2013   (final data collection date for primary outcome measure)
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 compare the effects of sildenafil versus placebo on exercise capacity (maximal oxygen consumption: VO2 max) for children with the Fontan circulation (8 -18 years). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Short-term treatment with sildenafil will augment cardiac output and improve exercise capacity (maximal oxygen consumption: VO2 max) in children with the Fontan circulation. Primary outcome variables include the change in peak exercise capacity (VO2 max), using cycle ergometry after one week of sildenafil therapy.
Complete list of historical versions of study NCT01291069 on ClinicalTrials.gov Archive Site
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.
To evaluate the adverse effects of sildenafil in children with the Fontan circulation (8 -18 years) and compare with the placebo group. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Hypothesis: Short-term treatment with sildenafil will be well tolerated by children with the Fontan circulation. Adverse effect forms will be used to compare the side effects between sildenafil and treatment group.
Not Provided
Not Provided
 
Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients
Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Single Ventricle
  • 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
  • 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
  • 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.
    Intervention: Drug: Tadalafil Citrate
  • 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.
    Intervention: Drug: Sugar pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
44
Not Provided
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who have undergone the Fontan procedure (regardless of type of Fontan connection or presence or absence of a fenestration)
  • Age 8.0 to 35.0 years
  • Stable clinical condition over the last 3 months (i.e. No change in medication, treatments, or development of new symptoms)
  • Ability to perform exercise testing
  • Consent and assent (as appropriate to participate in the study after receiving information concerning procedures, risks, and possible clinical benefits) o Patients will be enrolled without regard to gender, race, and ethnicity. All patients meeting study eligibility will be approached for consent.

Exclusion Criteria:

  • Severe heart failure (New York Heart Association functional class III or IV)
  • Presence of liver or renal dysfunction based on the latest lab test results
  • Presence of hearing or visual deficit
  • Transcutaneous arterial blood oxygen saturation (SaO2) <80% at rest
  • History of echocardiographic, MRI, or angiographic evidence of Fontan pathway obstruction
  • History of exercise-induced life-threatening arrhythmias or unstable rhythm(i.e. atrial flutter)
  • Known or suspected pregnancy. Females in the reproductive age group will be screened for pregnancy using serum beta hCG prior to administering study drug.
  • Patients on open label sildenafil or tadalafil
Both
8 Years to 35 Years
No
Contact: Linda M. Lambert, APRN 801 662 5573 linda.lambert@imail.org
United States
 
NCT01291069
IRB_00050085
Yes
Shaji Menon, University of Utah
University of Utah
Not Provided
Principal Investigator: Shaji C. Menon, MD University of Utah
University of Utah
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP