Trial Outcomes & Findings for The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease (NCT NCT01971593)

NCT ID: NCT01971593

Last Updated: 2018-05-04

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 26 participants
• Primary outcome timeframe: Baseline, 6 months and 12 months from eplerenone administration
• Results posted on: 2018-05-04

Participant Flow

Participant milestones

Measure	Eplerenone After Drug Free Period Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period Eplerenone	Eplerenone Before Drug Free Period Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period Eplerenone
Overall Study STARTED	14	12
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease

Baseline characteristics by cohort

Measure	Total Study Group n=26 Participants Crossover study, all patients pooled for baseline analysis
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Tetralogy of Fallot	12 Participants n=5 Participants
Patients with Transposition of the Great Vessels with a Systemic Right Ventricle (RV)	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months and 12 months from eplerenone administration

Population: Outcome analyzed only during the eplerenone period as specified in the protocol

Outcome measures

Measure	Total Study Group n=17 Participants Change from baseline at time of drug initiation
Procollagen N-terminal Peptide 1 6 Months	48.9 ug/ml Standard Deviation 20.3
Procollagen N-terminal Peptide 1 Baseline	45.1 ug/ml Standard Deviation 15.4
Procollagen N-terminal Peptide 1 12 Months	42.7 ug/ml Standard Deviation 12.2

PRIMARY outcome

Timeframe: Baseline, 6 months and 12 months from eplerenone administration

Population: Outcome analyzed only during the eplerenone period as specified in the protocol

Outcome measures

Measure	Total Study Group n=17 Participants Change from baseline at time of drug initiation
Procollagen III N-Terminal Peptide Baseline	4.6 ug/ml Standard Deviation 1.7
Procollagen III N-Terminal Peptide 6 Months	4.4 ug/ml Standard Deviation 1.5
Procollagen III N-Terminal Peptide 12 Months	4.4 ug/ml Standard Deviation 1.5

PRIMARY outcome

Timeframe: Baseline, 6 months and 12 months from eplerenone administration

Population: Outcome analyzed only during the eplerenone period as specified in the protocol

Outcome measures

Measure	Total Study Group n=17 Participants Change from baseline at time of drug initiation
Galectin 3 Baseline	10.0 ng/ml Standard Deviation 2.4
Galectin 3 6 Months	11.6 ng/ml Standard Deviation 2.9
Galectin 3 12 Months	11.2 ng/ml Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months from eplerenone administration

Population: Outcome analyzed only during the eplerenone period as specified in the protocol

Outcome measures

Measure	Total Study Group n=17 Participants Change from baseline at time of drug initiation
6 Minute Walk Baseline	1629 Feet Standard Deviation 261
6 Minute Walk 6 Months	1630 Feet Standard Deviation 250
6 Minute Walk 12 Months	1680.2 Feet Standard Deviation 255

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months from eplerenone administration

Population: Outcome analyzed only during the eplerenone period as specified in the protocol

Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function

Outcome measures

Measure	Total Study Group n=17 Participants Change from baseline at time of drug initiation
Quality of Life Baseline	87.5 Score on a scale Interval 70.0 to 95.0
Quality of Life 6 Months	90 Score on a scale Interval 75.0 to 97.5
Quality of Life 12 Months	85 Score on a scale Interval 75.0 to 95.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 months, 12 months from eplerenone administration

Population: Outcome analyzed only during the eplerenone period as specified in the protocol

Outcome measures

Measure	Total Study Group n=17 Participants Change from baseline at time of drug initiation
Serum Creatinine Baseline	0.9 mg/dl Standard Deviation 0.2
Serum Creatinine 6 Months	0.9 mg/dl Standard Deviation 0.2
Serum Creatinine 12 Months	0.9 mg/dl Standard Deviation 0.2

Adverse Events

Eplerenone Period

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Eplerenone Period n=26 participants at risk Change from baseline at time of drug initiation
Musculoskeletal and connective tissue disorders Leg cramping	3.8% 1/26 • Number of events 1 • During 12 months while on eplerenone Adverse event data only collected during the eplerenone period
Nervous system disorders dizziness	3.8% 1/26 • Number of events 1 • During 12 months while on eplerenone Adverse event data only collected during the eplerenone period
Renal and urinary disorders hyperkalemia	3.8% 1/26 • Number of events 1 • During 12 months while on eplerenone Adverse event data only collected during the eplerenone period
Skin and subcutaneous tissue disorders edema	7.7% 2/26 • Number of events 2 • During 12 months while on eplerenone Adverse event data only collected during the eplerenone period
Cardiac disorders chest pain	3.8% 1/26 • Number of events 1 • During 12 months while on eplerenone Adverse event data only collected during the eplerenone period
Cardiac disorders hypotension	3.8% 1/26 • Number of events 1 • During 12 months while on eplerenone Adverse event data only collected during the eplerenone period

Additional Information

Ari Cedars

UT Southwestern

Phone: 3149224788

Email: acedars97@gmail.com

Results disclosure agreements

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