Ignite Creation Date:
2024-05-06 @ 1:37 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01857856
Status:
COMPLETED
Last Update Posted:
2021-10-18
First Post:
2013-05-08
Brief Title:
PHOspholamban RElated CArdiomyopathy STudy - Intervention
Sponsor:
Mp van den Berg MD PhD professor in Cardiology
Organization:
University Medical Center Groningen
Study Overview
Official Title:
PHOspholamban RElated CArdiomyopathy STudy - Intervention Efficacy Study of Eplerenone in Presymptomaticphospholamban R14del Carriers
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
i-PHORECAST
Brief Summary:
Phospholamban PLN R14del mutation carriers may develop dilated cardiomyopathy DCM andor 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 mineralocorticoidaldosterone-blocking properties is a strong antifibrotic agent reduces disease progression and postpones onset of overt disease
Detailed Description:
In the Netherlands 15 of idiopathic dilated cardiomyopathy DCM and 10 arrhythmogenic right ventricular cardiomyopathy ARVC patients carry a single founder mutation in the gene encoding Phospholamban PLN R14del 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 mineralocorticoidaldosterone-blocking properties is a strong antifibrotic agent reduces disease progression and postpones onset of overt disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-001067-23 | EUDRACT_NUMBER | None | None |