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

Phase 4

Terminated

• Conditions: Fontan Procedure
• Interventions: Drug: Aspirin

• Registration Number: NCT02966002
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-17
• Primary Completion: 2017-05-25
• Study Completion: 2017-05-25
• Results First Submitted: 2018-04-17
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-17
• Last Update Submitted: 2018-05-17
• Results First Posted: 2018-05-18
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention: aspirin	Aspirin	650 mg. Twice a day for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in Total Cholesterol	8 weeks	Change will be measured from baseline to retest after 8 weeks of treatment
Change in HDL (High-Density Lipoprotein)-Cholesterol	8 weeks	Change will be measured from baseline to retest after 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
High Sensitivity CRP(C-Reactive Protein)	8 weeks	Change will be measured from baseline to retest after 8 weeks of treatment
Quality of Life	8 weeks	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States