Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients

Single Ventricle Clinical Trial

Official title:

Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291069
• Other study ID #: IRB_00050085
• Status: Completed
• Phase: Phase 1
• First received: February 4, 2011
• Last updated: April 14, 2017
• Start date: September 2011
• Est. completion date: February 2014

Study information

• Verified date: April 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Single Ventricle

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Primary Childrens Medical Center	Salt lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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	2 years
Secondary	To evaluate the adverse effects of Tdalafil in patients (8-35 years)with the Fontan circulation and compare with the placebo group.	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.	2 years