The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation

NCT00964782 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 31171
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.

Conditions

Fontan Circulation

Keywords

Fontan; sildenafil; exercise capacity; Patients with Fontan Circulation

Outcome Measures

Primary Outcomes (2)

• The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2)

  A change in exercise capacity measured via maximum oxygen consumed during exercise (VO2). The measurement will be obtained from the Exercise Stress Test

  baseline to 1 hour

• The Change in Exercise Capacity Measured Via Exercise Time

  A change in exercise capacity measured via exercise time (in minutes). The measurement will be obtained from the Exercise Stress Test

  baseline to 1 hour

Secondary Outcomes (3)

• The Change in Exercise Capacity Measured Via Maximum Heart Rate

  Baseline to 1 Hour

• The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels.

  Baseline to 1 Hour

• The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs).

  Baseline to 1 hour

Study Arms (2)

Sildenafil crossover to placebo

ACTIVE COMPARATOR

Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with treatment 2, placebo drug administered before the exercises.

Drug: Sildenafil; Drug: Placebo 2

Placebo crossover to sidenafil

PLACEBO COMPARATOR

Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with treatment 2 Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.

Drug: Placebo; Drug: Sildenafil 2

Interventions

Sildenafil DRUG

oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will be randomized to receive Sildenafil first and then crossed over to receive the opposite intervention, placebo.

Also known as: Viagra

Sildenafil crossover to placebo

Placebo DRUG

Patient will receive a look-alike placebo. Enrolled patients will be randomized to receive Placebo first and then crossed over to receive the opposite intervention, Sildenafil.

Also known as: Ora-sweet and Ora-plus (1:1 ratio).

Placebo crossover to sidenafil

Sildenafil 2 DRUG

oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will receive Sildenafil, the crossed over intervention from their initial intervention (Placebo).

Also known as: Viagra

Placebo crossover to sidenafil

Placebo 2 DRUG

Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil).

Also known as: Ora-sweet and Ora-plus (1:1 ratio).

Sildenafil crossover to placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-17 years
• Male or female
• Possess Fontan Circulation

You may not qualify if:

• Severe heart failure (New York Heart Ass. functional class IV)
• Evidence of Fontan pathway obstruction
• History of exercise-induced severe arrhythmias
• Pregnancy (known or suspected)
• Orthopedic limitations that prevent ambulation on a treadmill
• Use of nitroglycerin
• Herbal medications

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Children's Miracle Network: collaborator

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Compliance Specialist
• Organization: Milton S. Hershey Medical Center

clinicaltrials.gov@pennstatehealth.psu.edu

7175310003

Study Officials

• Devyani Chowdhury, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2009
• First Posted: August 25, 2009
• Study Start: August 1, 2009
• Primary Completion: May 24, 2012
• Study Completion: May 24, 2012
• Last Updated: March 26, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-03

Locations

US (1)