CArdiac Sarcoidosis Response TO steRoids (CASTOR) Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Heart failure hospitalization and sustained ventricular arrhythmia
研究概览
简要总结
There are no published clinical consensus guidelines on the treatment of cardiac sarcoidosis. Corticosteroid therapy is advocated by some experts, but is based on small observational studies, with varied clinical response.
Objectives of this trial:
- to systemically assess the response of patients with cardiac sarcoidosis, to treatment with corticosteroids
- to identify the clinical predictors of response to treatment with corticosteroids
- to assess the utility of imaging with PET and MRI to predict response to treatment with corticosteroids
- to determine the prevalence of cardiac sarcoidosis in young patients with unexplained heart block and in patients with unexplained dilated cardiomyopathy associated with ventricular tachycardia
- to use the data from this pilot study to assess the need, feasibility, and sample size for a larger multicentre trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •evidence of clinical cardiac sarcoidosis causing significant conduction system disease (defined as complete right bundle branch block and left axis deviation or left bundle branch block or second or third degree AV block in young patients (< 60 yrs) AND/OR
- •evidence of clinical cardiac sarcoidosis causing non-ischemic dilated cardiomyopathy and sustained ventricular tachycardia AND
- •PET or MRI imaging supporting the diagnosis of cardiac sarcoidosis
排除标准
- •unable or unwilling to provide informed consent
- •history of noncompliance of medical therapy
- •patients with active infection
- •patients with active inflammatory disease not related to sarcoidosis
- •patients with other known causes of heart block or LV dysfunction
- •patients with known active malignancy
- •patients wwho are pregnant or lactating
- •patients with other indications for steroids
研究组 & 干预措施
Placebo
Matching placebo tablets(s) taken orally per day
干预措施: Prednisone (Drug)
Prednisone
Prednisone 0.5 mg/Kg per day orally for 3 months
干预措施: Prednisone (Drug)
结局指标
主要结局
Heart failure hospitalization and sustained ventricular arrhythmia
时间窗: 3 months
Considered a responder to steroid therapy if alive, no heart failure hospitalization and no sustained ventricular arrhythmia, and improvement in one or both of: 1. LV function (defined as 5% increase in EF units or 10% decrease in volumes) 2. greater than or equal to one heart block grade (defined as improvement from eg. third to second degree AV block or resolution of bundle branch block)
次要结局
- Change in disease activity by PET imaging(3 months)
研究者
David Birnie
MD
Ottawa Heart Institute Research Corporation