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

Fontan Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02966002
• Other study ID #: HUM00100325
• Status: Terminated
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: May 25, 2017

Study information

• Verified date: May 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: May 25, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fontan Procedure

Intervention

Drug:
• Aspirin

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Cholesterol	Change will be measured from baseline to retest after 8 weeks of treatment	8 weeks
Primary	Change in HDL (High-Density Lipoprotein)-Cholesterol	Change will be measured from baseline to retest after 8 weeks of treatment	8 weeks
Secondary	High Sensitivity CRP(C-Reactive Protein)	Change will be measured from baseline to retest after 8 weeks of treatment	8 weeks
Secondary	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.	8 weeks