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Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT01291069
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
29
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Tadalafil Citrate
  • Drug: Sugar pill
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Ora sweet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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). [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

    Secondary Outcome Measures

    1. To evaluate the adverse effects of Tdalafil in patients (8-35 years)with the Fontan circulation and compare with the placebo group. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Primary Childrens Medical Center Salt lake City Utah United States 84113

    Sponsors and Collaborators

    • University of Utah

    Investigators

    • Principal Investigator: Shaji C. Menon, MD, University of Utah

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shaji Menon, Assistant Professor, University of Utah
    ClinicalTrials.gov Identifier:
    NCT01291069
    Other Study ID Numbers:
    • IRB_00050085
    First Posted:
    Feb 7, 2011
    Last Update Posted:
    Apr 17, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Shaji Menon, Assistant Professor, University of Utah
    Fontan
    Tadalafil
    Exercise performance
    Additional relevant MeSH terms:
    Univentricular Heart
    Tadalafil

    Study Results

    No Results Posted as of Apr 17, 2017