NL-OMON41504已完成3 期
PHOspholamban RElated CArdiomyopathy STudy - intervention (i-PHORECAST) - i-PHORECAST
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •PLN R14del mutation carriers
- •Age >=18 and <= 65 years
- •New York Heart Association functional class <= 1
- •LV ejection fraction >=.45 (measured with MRI)
排除标准
- •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 >2500 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/1.73m^2)
- •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
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