Phospolamban heart muscle disorder

• Conditions: Phospholamban-related Cardiomyopathy; MedDRA version: 16.1Level: LLTClassification code 10061029Term: Cardiomyopathy primarySystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001067-23-NL
• Lead Sponsor: niversity Medical Centre Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-18
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

PLN R14del mutation carriers
Age =30 and = 65 years
New York Heart Association functional class = 1
LV ejection fraction =.45 (measured with MRI)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Palpitations necessitating treatment (at the discretion of the attending physician)
•A diagnosis of DCM (see appendix 1). Note: regional LV wall motions abnormalities are acceptable.
•A diagnosis of ARVC (according to the task force criteria)
•Global or regional RV dysfunction and/or structural alterations (according to
task force criterion 1).
•Ventricular premature complexes >1000 during 24hours Holter-monitoring
•Non-sustained ventricular tachycardia during Holter-monitoring or exercise-testing
•History of sustained ventricular tachycardia or ventricular fibrillation
•Hypertension requiring the use of antihypertensive drugs, or when this is
anticipated within the coming 3 years
•Evidence of ischemic heart disease
•Treatment with cardioactive medication
•Hyperkaliemia (serum potassium >5.0 mmol/l)
•Severe renal dysfunction (eGFR <30 ml/min/1.73 m2)
•Severe hepatic impairment (Child-Pugh class C)
•Women who are currently pregnant or report a recent pregnancy (last 60 days) or plan on becoming pregnant.
•Concomitant use of CYP3A4-inhibitors
•Concomitant use of NSAIDs
•Concomitant use of potassium highering/sparing-agents
•Known intolerance or contraindication to aldosterone antagonists
•Participation in another drug trial in which the last dose of drug was within the past 30 days.
•Contra-indications for MRI (claustrophobia, metal devices)
•Subjects unable or unwilling to provide written informed consent
Note: presence of late gadolinium enhancement on MRI is not an exclusion criterion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified