Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT01857856
Eligibility Criteria:
Inclusion Criteria:
* Phospholamban (PLN) R14del mutation carriers
* Age ≥30 and ≤ 65 years
* New York Heart Association functional class ≤ 1
* LV ejection fraction ≥.45 (measured with MRI)
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, see appendix 2)
* Global or regional RV dysfunction and/or structural alterations (according to task force criterion 1, see appendix 2).
* 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 (see appendix 5)
* Concomitant use of NSAIDs (see appendix 5)
* Concomitant use of potassium sparing-agents (see appendix 5)
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT01857856
Study Brief:
Protocol Section:
NCT01857856