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

University of Michigan

Status and phase: Terminated; Phase 4

Conditions: Fontan Procedure

Treatments: Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02966002

HUM00100325

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Intervention: aspirin

Experimental group

Description:

650 mg. Twice a day for 8 weeks

Treatment:

Drug: Aspirin