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PHOspholamban RElated CArdiomyopathy STudy - Intervention

NCT01857856 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-10-18

No results posted yet for this study

Summary

Phospholamban (PLN) R14del mutation carriers may develop dilated cardiomyopathy (DCM) and/or arrhythmmogenic cardiomyopathy (ACM). Analogous to other inherited cardiomyopathies, the natural course of the disease is age-related ("age-related penetrance"); after a presymptomatic phase of variable length many PLN R14del-carriers progress to overt disease, and are diagnosed with either DCM or ARVC. PLN is a regulator of the sarcoplasmic reticulum Ca2+-ATPase (SERCA2a) pump in cardiac muscle and thereby important for maintaining Ca2+ homeostasis. Cardiac fibrosis appears to be an early manifestation of disease. The investigators hypothesize that treatment of presymptomatic PLN R14del-carriers with eplerenone, which by virtue of its mineralocorticoid(aldosterone)-blocking properties is a strong antifibrotic agent, reduces disease progression and postpones onset of overt disease.

Conditions

  • Phospholamban R14del Mutation-related Cardiomyopathy

Interventions

DRUG

Eplerenone

eplerenone (inspra; pfizer) one tablet (50mg standard dosis; 25mg reduced dosis) per day

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • The Interuniversity Cardiology Institute of the Netherlands

    collaborator OTHER_GOV

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Netherlands: CVON, CardioVascular Research Netherlands

    collaborator UNKNOWN

  • M.p. van den Berg, MD, PhD, professor in Cardiology

    lead OTHER

Principal Investigators

  • Maarten van den Berg, MD PhD · UMCG, Department of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2021-10-31
Completion
2021-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01857856 on ClinicalTrials.gov