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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-05-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Fontan Procedure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention: aspirin

650 mg. Twice a day for 8 weeks

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Interventions

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Aspirin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults who have Fontan repair of single ventricle

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No