Trial Outcomes & Findings for Spironolactone in Adult Congenital Heart Disease (NCT NCT01069510)

NCT ID: NCT01069510

Last Updated: 2019-08-21

Results Overview

extracellular volume fraction measured by T1 mapping with MRI

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: 12 month
• Results posted on: 2019-08-21

Participant Flow

Recruited at time of presentation for larger study. However, most did not meet enrollment criteria and could not be randomized.

Participant milestones

Measure	Placebo Patients will receive placebo Placebo: Placebo daily for 12 months	Spironolactone Spironolactone 25 mg daily Spironolactone 25mg: Spironolactone 25 mg daily for 12 months
Overall Study STARTED	8	7
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Spironolactone in Adult Congenital Heart Disease

Baseline characteristics by cohort

Measure	Placebo n=8 Participants Patients will receive placebo Placebo: Placebo daily for 12 months	Spironolactone n=7 Participants Spironolactone 25 mg daily Spironolactone 25mg: Spironolactone 25 mg daily for 12 months	Total n=15 Participants Total of all reporting groups
Age, Continuous	36 years STANDARD_DEVIATION 6 • n=5 Participants	38 years STANDARD_DEVIATION 16 • n=7 Participants	37 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 month

extracellular volume fraction measured by T1 mapping with MRI

Outcome measures

Measure	Placebo n=8 Participants Patients will receive placebo Placebo: Placebo daily for 12 months	Spironolactone n=7 Participants Spironolactone 25 mg daily Spironolactone 25mg: Spironolactone 25 mg daily for 12 months
Extracellular Volume Fraction	30.1 percentage of myocardium Standard Deviation 3.8	25.3 percentage of myocardium Standard Deviation 1.5

SECONDARY outcome

Timeframe: 12 month

distance walked recorded in meters after 6 minutes on flat ground

Outcome measures

Measure	Placebo n=8 Participants Patients will receive placebo Placebo: Placebo daily for 12 months	Spironolactone n=7 Participants Spironolactone 25 mg daily Spironolactone 25mg: Spironolactone 25 mg daily for 12 months
6-minute Walk Distance	516 meters Standard Deviation 124	492 meters Standard Deviation 138

SECONDARY outcome

Timeframe: 12 months

Population: Limited samples obtained from participants

Outcome measures

Measure	Placebo n=1 Participants Patients will receive placebo Placebo: Placebo daily for 12 months	Spironolactone n=3 Participants Spironolactone 25 mg daily Spironolactone 25mg: Spironolactone 25 mg daily for 12 months
Procollagen 3 NT Peptide	3 mcg/l Standard Deviation .7	4.8 mcg/l Standard Deviation 1.2

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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. Craig Broberg

Oregon Health and Science Univ.

Phone: 503-494-7400

Email: brobergc@ohsu.edu

Results disclosure agreements

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