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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Single Ventricle
 Drug: Tadalafil Citrate
Drug: Sugar pill
 Phase 1

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 44
Study Start Date: September 2011
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291069

Contacts
Contact: Linda M. Lambert, APRN 801 662 5573 linda.lambert@imail.org

Locations
United States, Utah
Primary Childrens Medical Center Recruiting
Salt lake City, Utah, United States, 84113
Contact: Shaji C. Menon, MD     801-662-5400     shaji.menon@imail.org    
Contact: Linda Lambert, APRN     801 662 5573     linda.lambert@imail.org    
Principal Investigator: Shaji C. Menon, MD            
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Shaji C. Menon, MD University of Utah
  More Information

No publications provided

Responsible Party: Shaji Menon, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01291069     History of Changes
Other Study ID Numbers: IRB_00050085
Study First Received: February 4, 2011
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
Fontan
Tadalafil
Exercise performance

Additional relevant MeSH terms:
Citric Acid
Tadalafil
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
 Molecular Mechanisms of Pharmacological Action
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013