Fontan CirculationPhase 4NCT00964782
The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation
A Phase 4 study testing Sildenafil and Sildenafil 2 in people with Fontan Circulation, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Fontan Circulation
- What is being tested?
- Sildenafil and Sildenafil 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to 24 May 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6-17 years
- Male or female
- Possess Fontan Circulation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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
- Being tested
- Sildenafil, Placebo, Sildenafil 2, Placebo 2
- Keywords
- Fontan, sildenafil, exercise capacity, Patients with Fontan Circulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Viagra
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.
PlaceboDrug
Also called Ora-sweet and Ora-plus (1:1 ratio).
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.
Sildenafil 2Drug
Also called Viagra
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).
Placebo 2Drug
Also called Ora-sweet and Ora-plus (1:1 ratio).
Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Drug: Sildenafil 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline to 1 hour
Secondary outcomes (3)
The Change in Exercise Capacity Measured Via Maximum Heart Rate
A change in exercise capacity measured via maximum heart rate (in beats per minute). The measurement will be obtained from the Exercise Stress Test
Measured: Baseline to 1 Hour
The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels.
A change in exercise capacity measured via minimum oxygen saturation (%). The measurement will be obtained from the Exercise Stress Test
Measured: Baseline to 1 Hour
The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs).
A change in exercise capacity measured via metabolic equivalents of task (METs). The measurement will be obtained from the Exercise Stress Test. One MET is defined as 3.5 mL 02 uptake/kg per minute
Measured: Baseline to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startAug 2009
- Primary completion24 May 2012
- Study completion24 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fontan CirculationStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Miracle Network
- Responsible party
- Sponsor
- Investigators
- Devyani Chowdhury, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964782
- Sponsor's protocol ID
- 31171
- Status last verified
- Mar 2019
- First submitted
- 21 Aug 2009
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation
- ClinicalTrials.gov ID
- NCT00964782
- Acronym / sponsor ID
- 31171
- Conditions
- Fontan Circulation
- Keywords
- Fontan, sildenafil, exercise capacity, Patients with Fontan Circulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Children's Miracle Network
- Study start
- Aug 2009
- Primary completion
- 24 May 2012 (actual)
- Study completion
- 24 May 2012 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil crossover to placebo | Active comparator | Drug: Sildenafil, Drug: Placebo 2Sildenafil 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. |
| Placebo crossover to sidenafil | Placebo comparator | Drug: Placebo, Drug: Sildenafil 2Patient 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 6-17 years
- Male or female
- Possess Fontan Circulation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilAlso: Viagraoral 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. | Drug | Sildenafil crossover to placebo |
| PlaceboAlso: Ora-sweet and Ora-plus (1:1 ratio).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. | Drug | Placebo crossover to sidenafil |
| Sildenafil 2Also: Viagraoral 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). | Drug | Placebo crossover to sidenafil |
| Placebo 2Also: Ora-sweet and Ora-plus (1:1 ratio).Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil). | Drug | Sildenafil crossover to placebo |
Primary outcome
The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2)
Time frame: baseline to 1 hour
A change in exercise capacity measured via maximum oxygen consumed during exercise (VO2). The measurement will be obtained from the Exercise Stress Test
The Change in Exercise Capacity Measured Via Exercise Time
Time frame: baseline to 1 hour
A change in exercise capacity measured via exercise time (in minutes). The measurement will be obtained from the Exercise Stress Test
3 secondary outcomes
The Change in Exercise Capacity Measured Via Maximum Heart Rate
Time frame: Baseline to 1 Hour
The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels.
Time frame: Baseline to 1 Hour
The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs).
Time frame: Baseline to 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Fontan Circulation
Not yet recruitingObservational study
A Simple Method for Monitoring the End-organ Function in Patients With Fontan Circulation.
Fontan Procedure, Fontan Circulation
RecruitingPhase 3
SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure
Congenital Heart Disease
Enrolling by invitation
Feasibility of Non-invasive Hemodynamic Assessment by 5D Flow in Congenital Heart Disease
Pulmonary Hypertension, Right Ventricular Outflow Tract Dysfunction
Recruiting
Venous Compression in Fontan
Single-ventricle, Fontan Circulation
RecruitingPhase 2
CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation
Fontan Circulation, Single Ventricle Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devyani Chowdhury, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sildenafil and Sildenafil 2 in people with Fontan Circulation, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2) (time frame: baseline to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.