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

May 17, 2018 updated by: Adam Lubert, University of Michigan
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention: aspirin
650 mg. Twice a day for 8 weeks
Drug: Aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Cholesterol
Time Frame: 8 weeks
Change will be measured from baseline to retest after 8 weeks of treatment
8 weeks
Change in HDL (High-Density Lipoprotein)-Cholesterol
Time Frame: 8 weeks
Change will be measured from baseline to retest after 8 weeks of treatment
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High Sensitivity CRP(C-Reactive Protein)
Time Frame: 8 weeks
Change will be measured from baseline to retest after 8 weeks of treatment
8 weeks
Quality of Life
Time Frame: 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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Adam Lubert, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

May 25, 2017

Study Completion (Actual)

May 25, 2017

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 17, 2016

Study Record Updates

Last Update Posted (Actual)

May 18, 2018

Last Update Submitted That Met QC Criteria

May 17, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00100325

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fontan Procedure

Clinical Trials on Aspirin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe