Skip to main content
OpenTrials
Completed

NCT Number: NCT01291069

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Single Ventricle Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Univentricular Heart

Age range

8 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Primary Childrens Medical Center

Salt Lake City, Utah, 84113, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tadalafil Citrate

Drug

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

Sugar pill

Drug

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

Primary outcomes

  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).

    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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 7, 2011
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.