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

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ClinicalTrials.gov Identifier: NCT01971593
Recruitment Status : Terminated (Investigator left institution)
First Posted : October 29, 2013
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ari Cedars, Washington University School of Medicine

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.


Condition or disease Intervention/treatment Phase
Tetralogy of Fallot Transposition of the Great Vessels With an Arterial Switch Single Ventricle With a Fontan Palliation Drug: Eplerenone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease
Study Start Date : August 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Eplerenone after drug free period
Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period
Drug: Eplerenone
Other Name: Inspra

Eplerenone before drug free period
Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period
Drug: Eplerenone
Other Name: Inspra




Primary Outcome Measures :
  1. Procollagen N-terminal Peptide 1 [ Time Frame: Baseline, 6 months and 12 months from eplerenone administration ]
  2. Procollagen III N-Terminal Peptide [ Time Frame: Baseline, 6 months and 12 months from eplerenone administration ]
  3. Galectin 3 [ Time Frame: Baseline, 6 months and 12 months from eplerenone administration ]

Secondary Outcome Measures :
  1. 6 Minute Walk [ Time Frame: Baseline, 6 months, 12 months from eplerenone administration ]
  2. Quality of Life [ Time Frame: Baseline, 6 months, 12 months from eplerenone administration ]
    Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function


Other Outcome Measures:
  1. Serum Creatinine [ Time Frame: Baseline, 6 months, 12 months from eplerenone administration ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971593


Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Pfizer

Responsible Party: Ari Cedars, Assistant Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01971593     History of Changes
Other Study ID Numbers: WI170964
First Posted: October 29, 2013    Key Record Dates
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Transposition of Great Vessels
Heart Diseases
Heart Defects, Congenital
Tetralogy of Fallot
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Eplerenone
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents