Trial Outcomes & Findings for Spironolactone in Patients With Single Ventricle Heart (NCT NCT00211081)

NCT ID: NCT00211081

Last Updated: 2017-11-06

Results Overview

Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline, Post-Intervention (4 Weeks)
• Results posted on: 2017-11-06

Participant Flow

Participant milestones

Measure	Spironolactone Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Spironolactone Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Spironolactone in Patients With Single Ventricle Heart

Baseline characteristics by cohort

Measure	Spironolactone n=12 Participants Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Post-Intervention (4 Weeks)

Population: Subjects that completed all study visits.

Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area.

Outcome measures

Measure	Spironolactone n=10 Participants Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
Change in Flow Mediated Dilation	5.5 Percentage of brachial artery diameter Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline, Post-Intervention (4 Weeks)

Population: Subjects that completed all study visits.

The normal reference range for C-reactive protein is as follows: CRP: 0-10mg/L

Outcome measures

Measure	Spironolactone n=10 Participants Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
C-Reactive Protein Level Baseline	1.10 mg/L Interval 0.15 to 21.4
C-Reactive Protein Level 4 Week Follow Up	1.10 mg/L Interval 0.17 to 19.95

SECONDARY outcome

Timeframe: Baseline, Post-Intervention (4 Weeks)

Population: Subjects that completed all study visits.

The normal result for IL-6 for Interleukin 6 is < 5pg/ml.

Outcome measures

Measure	Spironolactone n=10 Participants Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
Interleukin-6 (IL-6) Level Baseline	1.96 pg/ml Interval 1.18 to 14.78
Interleukin-6 (IL-6) Level 4 Week Follow Up	1.54 pg/ml Interval 1.29 to 5.29

SECONDARY outcome

Timeframe: Baseline, Post-Intervention (4 Weeks)

Population: Subjects that completed all study visits.

The normal result for IL1b is <3.9 pg/mL.

Outcome measures

Measure	Spironolactone n=10 Participants Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
Interleukin 1 Beta (IL1b) Level Baseline	.38 pg/mL Interval 0.23 to 0.53
Interleukin 1 Beta (IL1b) Level 4 Week Follow Up	.23 pg/mL Interval 0.08 to 0.48

SECONDARY outcome

Timeframe: Baseline, Post-Intervention (4 Weeks)

Population: Subjects that completed all study visits.

The normal result for IL-10 for Interleukin 10 is < 18pg/ml.

Outcome measures

Measure	Spironolactone n=10 Participants Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
Interleukin-10 (IL10) Level Baseline	.26 18pg/ml Interval 0.1 to 0.36
Interleukin-10 (IL10) Level 4 Week Follow Up	.13 18pg/ml Interval 0.1 to 0.7

SECONDARY outcome

Timeframe: Baseline, Post-Intervention (4 Weeks)

Population: Subjects that completed all study visits.

The normal result for TNF-a is <5.6 pg/mL.

Outcome measures

Measure	Spironolactone n=10 Participants Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
Tumor Necrosis Factor-Alpha (TNF-a) Level 4 Week Follow Up	2.42 pg/mL Interval 1.54 to 5.94
Tumor Necrosis Factor-Alpha (TNF-a) Level Baseline	2.20 pg/mL Interval 1.17 to 5.72

SECONDARY outcome

Timeframe: Baseline, Post-Intervention (4 Weeks)

Population: This assessment was not completed during the study.

Outcome measures

Outcome data not reported

Adverse Events

Spironolactone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Willam Mahle

Emory University

Phone: 404-785-6000

Email: wmahle@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place