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

Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01971593
Enrollment
26
Registered
2013-10-29
Start date
2013-08-31
Completion date
2016-06-30
Last updated
2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Single Ventricle With a Fontan Palliation, Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch

Brief summary

Hypothesis: By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the great vessels with a prior atrial switch, and single ventricle Fontan patients, incident heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias decreased through decreases in myocardial fibrosis. Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6 minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months without therapy, after 6 months on therapy, then finally after 12 months of eplerenone therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12 months on therapy. Patients will be randomly assigned to drug free period up front versus at the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for monitoring.

Interventions

DRUGEplerenone

Sponsors

Pfizer
CollaboratorINDUSTRY
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Established diagnosis of tetralogy of Fallot, transposition of the great vessels with a systemic right ventricle, or Fontan type palliation * Patient followed regularly at Washington University-affiliated institution * If female, willing to use 2 forms of contraception including one barrier method during protocol

Exclusion criteria

* GFR \<30 ml/min * Potassium \>5.0 mmol/L * Unable or unwilling to comply with study protocol * Use of potassium sparing diuretics * Use of an aldosterone blocker currently or previously * Known intolerance of eplerenone or aldosterone blockade * Pregnant, breastfeeding, or actively trying to get pregnant

Design outcomes

Primary

MeasureTime frame
Procollagen N-terminal Peptide 1Baseline, 6 months and 12 months from eplerenone administration
Procollagen III N-Terminal PeptideBaseline, 6 months and 12 months from eplerenone administration
Galectin 3Baseline, 6 months and 12 months from eplerenone administration

Secondary

MeasureTime frameDescription
6 Minute WalkBaseline, 6 months, 12 months from eplerenone administration—
Quality of LifeBaseline, 6 months, 12 months from eplerenone administrationRand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function

Other

MeasureTime frame
Serum CreatinineBaseline, 6 months, 12 months from eplerenone administration

Countries

United States

Participant flow

Participants by arm

ArmCount
Total Study Group
Crossover study, all patients pooled for baseline analysis
26
Total26

Baseline characteristics

CharacteristicTotal Study Group
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
26 Participants
Patients with Transposition of the Great Vessels with a Systemic Right Ventricle (RV)14 Participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
17 Participants
Tetralogy of Fallot12 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 26
other
Total, other adverse events
6 / 26
serious
Total, serious adverse events
0 / 26

Outcome results

Primary

Galectin 3

Time frame: Baseline, 6 months and 12 months from eplerenone administration

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

ArmMeasureGroupValue (MEAN)Dispersion
Total Study GroupGalectin 312 Months11.2 ng/mlStandard Deviation 2.2
Total Study GroupGalectin 3Baseline10.0 ng/mlStandard Deviation 2.4
Total Study GroupGalectin 36 Months11.6 ng/mlStandard Deviation 2.9
Primary

Procollagen III N-Terminal Peptide

Time frame: Baseline, 6 months and 12 months from eplerenone administration

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

ArmMeasureGroupValue (MEAN)Dispersion
Total Study GroupProcollagen III N-Terminal PeptideBaseline4.6 ug/mlStandard Deviation 1.7
Total Study GroupProcollagen III N-Terminal Peptide6 Months4.4 ug/mlStandard Deviation 1.5
Total Study GroupProcollagen III N-Terminal Peptide12 Months4.4 ug/mlStandard Deviation 1.5
Primary

Procollagen N-terminal Peptide 1

Time frame: Baseline, 6 months and 12 months from eplerenone administration

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

ArmMeasureGroupValue (MEAN)Dispersion
Total Study GroupProcollagen N-terminal Peptide 1Baseline45.1 ug/mlStandard Deviation 15.4
Total Study GroupProcollagen N-terminal Peptide 16 Months48.9 ug/mlStandard Deviation 20.3
Total Study GroupProcollagen N-terminal Peptide 112 Months42.7 ug/mlStandard Deviation 12.2
Secondary

6 Minute Walk

Time frame: Baseline, 6 months, 12 months from eplerenone administration

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

ArmMeasureGroupValue (MEAN)Dispersion
Total Study Group6 Minute WalkBaseline1629 FeetStandard Deviation 261
Total Study Group6 Minute Walk6 Months1630 FeetStandard Deviation 250
Total Study Group6 Minute Walk12 Months1680.2 FeetStandard Deviation 255
Secondary

Quality of Life

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

Time frame: Baseline, 6 months, 12 months from eplerenone administration

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

ArmMeasureGroupValue (MEAN)
Total Study GroupQuality of LifeBaseline87.5 Score on a scale
Total Study GroupQuality of Life6 Months90 Score on a scale
Total Study GroupQuality of Life12 Months85 Score on a scale
Other Pre-specified

Serum Creatinine

Time frame: Baseline, 6 months, 12 months from eplerenone administration

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

ArmMeasureGroupValue (MEAN)Dispersion
Total Study GroupSerum CreatinineBaseline0.9 mg/dlStandard Deviation 0.2
Total Study GroupSerum Creatinine6 Months0.9 mg/dlStandard Deviation 0.2
Total Study GroupSerum Creatinine12 Months0.9 mg/dlStandard Deviation 0.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026