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

• Sponsor: University of Michigan (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02966002
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 13.8
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fontan Procedure	Drug: Aspirin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: May 25, 2017
• Actual Study Completion Date: May 25, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Total Cholesterol [8 weeks]

   Change will be measured from baseline to retest after 8 weeks of treatment

2. 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

1. High Sensitivity CRP(C-Reactive Protein) [8 weeks]

   Change will be measured from baseline to retest after 8 weeks of treatment

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 23, 2015

More Information

Publications

None provided.

• Responsible Party: Adam Lubert, Clinical Instructor, Pediatric Cardiology, University of Michigan
• ClinicalTrials.gov Identifier: NCT02966002
• Other Study ID Numbers: HUM00100325
• First Posted: Nov 17, 2016
• Last Update Posted: May 18, 2018
• Last Verified: May 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Additional relevant MeSH terms: Aspirin

Study Results

Participant Flow

Arm/Group Title	Intervention: Aspirin
Arm/Group Description	650 mg. Twice a day for 8 weeks Aspirin
Period Title: Overall Study
STARTED	9
COMPLETED	5
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Intervention: Aspirin
Arm/Group Description	650 mg. Twice a day for 8 weeks Aspirin
Overall Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	3 33.3%
Male	6 66.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	9 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Total Cholesterol (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	138.6 (16.6)
HDL Cholesterol (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	47.6 (15.1)
High Sensitivity C-Reactive Protein (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	0.24 (0.10)
Quality of Life (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	82.4 (7.0)

Outcome Measures

1. Primary Outcome

Title	Change in Total Cholesterol
Description	Change will be measured from baseline to retest after 8 weeks of treatment
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention: Aspirin
Arm/Group Description	650 mg. Twice a day for 8 weeks Aspirin
Measure Participants	5
Mean (Standard Deviation) [mg/dL]	-0.6 (15.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention: Aspirin
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.96
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention: Aspirin
Arm/Group Description	650 mg. Twice a day for 8 weeks Aspirin
Measure Participants	5
Mean (Standard Deviation) [mg/dL]	0.4 (17.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention: Aspirin
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.67
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	High Sensitivity CRP(C-Reactive Protein)
Description	Change will be measured from baseline to retest after 8 weeks of treatment
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention: Aspirin
Arm/Group Description	650 mg. Twice a day for 8 weeks Aspirin
Measure Participants	5
Mean (Standard Deviation) [mg/dL]	0.06 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention: Aspirin
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.18
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Quality of Life
Description	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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention: Aspirin
Arm/Group Description	650 mg. Twice a day for 8 weeks Aspirin
Measure Participants	5
Mean (Standard Deviation) [units on a scale]	86.5 (4.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention: Aspirin
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Intervention: Aspirin
Arm/Group Description	650 mg. Twice a day for 8 weeks Aspirin
All Cause Mortality
	Intervention: Aspirin
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Serious Adverse Events
	Intervention: Aspirin
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Intervention: Aspirin
	Affected / at Risk (%)	# Events
Total	1/5 (20%)
Gastrointestinal disorders
Bloody Bowel Movement	1/5 (20%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.