NCT01971593

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 4, 2018

Completed
Last Updated

May 4, 2018

Status Verified

April 1, 2018

Enrollment Period

2.6 years

First QC Date

October 23, 2013

Results QC Date

January 25, 2018

Last Update Submit

April 3, 2018

Conditions

Tetralogy of FallotTransposition of the Great Vessels With an Arterial SwitchSingle Ventricle With a Fontan Palliation

Outcome Measures

Primary Outcomes (3)

  • Procollagen N-terminal Peptide 1

    Baseline, 6 months and 12 months from eplerenone administration

  • Procollagen III N-Terminal Peptide

    Baseline, 6 months and 12 months from eplerenone administration

  • Galectin 3

    Baseline, 6 months and 12 months from eplerenone administration

Secondary Outcomes (2)

  • 6 Minute Walk

    Baseline, 6 months, 12 months from eplerenone administration

  • Quality of Life

    Baseline, 6 months, 12 months from eplerenone administration

Other Outcomes (1)

  • Serum Creatinine

    Baseline, 6 months, 12 months from eplerenone administration

Study Arms (2)

Eplerenone after drug free period

OTHER

Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period

Drug: Eplerenone

Eplerenone before drug free period

OTHER

Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period

Drug: Eplerenone

Interventions

EplerenoneDRUG
Also known as: Inspra
Eplerenone after drug free periodEplerenone before drug free period

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Tetralogy of Fallot

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Limitations and Caveats

Incomplete study enrollment led to inadequate power to derive reliable conclusions.

Results Point of Contact

Title
Ari Cedars
Organization
UT Southwestern
acedars97@gmail.com
3149224788

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 29, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

May 4, 2018

Results First Posted

May 4, 2018

Record last verified: 2018-04

Locations

US(1)