Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients

• Status: Terminated
• Trial end date: 2017-05-25
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Anti-Inflammatory Agents; Aspirin

Criteria

Inclusion Criteria:

• 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)

• Bleeding disorder

• Known esophageal varicies

• Consuming more than 10 alcoholic drinks per week.

• Pregnant

• Planning to become pregnant