NCT01559714已完成不适用
BE STRONG HCM: Biomarkers, Exercise Stress Testing, and mRi to Obtain New insiGhts in Hypertrophic CardioMyopathy Study
Heartcenter, University Medical Center St. Radboud1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2012年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Troponin levels at baseline and troponin rise after exercise testing using a high sensitivity-troponin (hs-troponin) assay
研究概览
简要总结
Study population: 1) mutation carriers without the hypertrophic phenotype (pre-clinical Hypertrophic Cardiomyopathy (HCM)) and in 2) patients with clinically overt HCM (clinical HCM).
Hypothesis: Cardiac troponin release after exercise can be demonstrated in both clinical and pre-clinical HCM patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC guidelines or individuals with a HCM associated mutation without the clinical characteristics of hypertrophic cardiomyopathy (pre-clinical HCM patients);
- •Age ≥ 18 years;
- •Able to comply with the protocol;
- •Written informed consent.
排除标准
- •Known significant epicardial coronary artery disease;
- •Patients with LVH in the clinical setting of other disorders that explain the myocardial hypertrophy (amyloidosis, MELAS, Anderson-Fabry, WPW etc.);
- •Heart failure NYHA class III-IV;
- •Patients with known hemodynamic instability or syncope during exercise due to left ventricular outflow gradient or occurrence of ventricular arrhythmia;
- •History of PTSMA (percutaneous transluminal septal myocardial ablation) or Morrow myectomy;
- •Patients not able to complete a bicycle test;
- •Any contraindication to MR imaging (MR imaging is not obligatory for assessment of the primary objective, therefore relative exclusion criterion);
- •Recent (within 30 days) admittance to the hospital for any cardiac reason (myocardial infarction, heart failure, cardiac arrhythmia, etc.);
- •Severe renal insufficiency (eGFR < 30 ml/min);
- •Any other condition which, in the opinion of the investigator, may pose a significant hazard to the subject if he or she participates in the present study.
结局指标
主要结局
Troponin levels at baseline and troponin rise after exercise testing using a high sensitivity-troponin (hs-troponin) assay
时间窗: Baseline, 6 and 24 hours after exercise
次要结局
- Correlation between troponin levels and phenotypic characteristics assessed with MRI (LV volumes, mass and ejection fraction, presence of LGE and/or elevated signal on T2-weighted imaging)(Baseline)
研究者
D.H.F. Gommans, MD
Principal Investigator
Heartcenter, University Medical Center St. Radboud
研究点 (1)
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