Fontan ProcedurePhase 4NCT02966002
Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
A Phase 4 study testing Aspirin in people with Fontan Procedure, run by University of Michigan at 1 site in United States.
Trial summary
Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop complications many years after their operation. Studies have shown that some of these patients develop an ongoing inflammatory state, which may be the cause of these late complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fontan Procedure
- What is being tested?
- Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 25 May 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults who have Fontan repair of single ventricle
- Exclusion Criteria: Persons with the following history, conditions, or behavior will be excluded
- Active protein losing enteropathy within the past three years
- Congestive heart failure
- Active arrhythmias
- Taking Coumadin (Warfarin)
Show all 11Show fewer
- Bleeding disorder
- Known esophageal varicies
- Consuming more than 10 alcoholic drinks per week.
- Pregnant
- Planning to become pregnant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop complications many years after their operation. Studies have shown that some of these patients develop an ongoing inflammatory state, which may be the cause of these late complications. Aspirin is a common over the counter anti-inflammatory medication used for many other chronic diseases. This study may help determine if aspirin therapy can limit the inflammation seen in Fontan patients and prevent these late complications.
- Conditions
- Fontan Procedure
- Being tested
- Aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
| Study group | Role | What they receive |
|---|---|---|
| Intervention: aspirin | Experimental | 650 mg. Twice a day for 8 weeks Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Cholesterol
Change will be measured from baseline to retest after 8 weeks of treatment
Measured: 8 weeks
Change in HDL (High-Density Lipoprotein)-Cholesterol
Change will be measured from baseline to retest after 8 weeks of treatment
Measured: 8 weeks
Secondary outcomes (2)
High Sensitivity CRP(C-Reactive Protein)
Change will be measured from baseline to retest after 8 weeks of treatment
Measured: 8 weeks
Quality of Life
The Medical Outcomes Short-Form 36-Item Health Survey (SF-36) is a standardized health survey consisting of 36 questions that measure 8 dimensions of general health-related quality of life: physical functioning, role limitation due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health. The score is represented as an average of the individual question scores, and ranges from 0 (not functioning) to 100 (highest functioning). Higher scores indicate a better health status.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startApr 2016
- Primary completion25 May 2017
- Study completion25 May 2017
Why it stopped: This study was terminated due to inability to recruit sufficient patients.
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 ProcedureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Lubert, University of Michigan
- Investigators
- Adam Lubert, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966002
- Sponsor's protocol ID
- HUM00100325
- Status last verified
- May 2018
- First submitted
- 15 Nov 2016
- Last updated
- 18 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
- ClinicalTrials.gov ID
- NCT02966002
- Acronym / sponsor ID
- HUM00100325
- Conditions
- Fontan Procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due to inability to recruit sufficient patients.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Posted 18 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop complications many years after their operation. Studies have shown that some of these patients develop an ongoing inflammatory state, which may be the cause of these late complications. Aspirin is a common over the counter anti-inflammatory medication used for many other chronic diseases. This study may help determine if aspirin therapy can limit the inflammation seen in Fontan patients and prevent these late complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: aspirin | Experimental | Drug: Aspirin650 mg. Twice a day for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults who have Fontan repair of single ventricle
- Exclusion Criteria: Persons with the following history, conditions, or behavior will be excluded
- Active protein losing enteropathy within the past three years
- Congestive heart failure
- Active arrhythmias
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Aspirin | Drug | Intervention: aspirin |
Primary outcome
Change in Total Cholesterol
Time frame: 8 weeks
Change will be measured from baseline to retest after 8 weeks of treatment
Change in HDL (High-Density Lipoprotein)-Cholesterol
Time frame: 8 weeks
Change will be measured from baseline to retest after 8 weeks of treatment
2 secondary outcomes
High Sensitivity CRP(C-Reactive Protein)
Time frame: 8 weeks
Quality of Life
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Fontan Procedure
Not yet recruitingObservational study
A Simple Method for Monitoring the End-organ Function in Patients With Fontan Circulation.
Fontan Procedure, Fontan Circulation
RecruitingObservational study
Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients
Fontan Procedure, Congenital Heart Disease
RecruitingPhase 3
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
Fontan Palliation
RecruitingPhase 4
The Effect of Dapagliflozin on Exercise and Cardiac Functional Status of Patients After Fontan Procedure
Fontan, Heart Failure
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
Prevention of Venous Thromboembolism, Congenital 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.
Adam Lubert, MD principal investigator
University of Michigan
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 Aspirin in people with Fontan Procedure, run by University of Michigan 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 11 inclusion and 0 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: stopped early, as of the sponsor's last update on 18 May 2018. 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. 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 18 May 2018). 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?
Change in Total Cholesterol (time frame: 8 weeks). 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 18 May 2018.