Treatment effects of Bisoprolol and Verapamil in symptomatic patients with non-obstructive hypertrophic cardiomyopathy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Phase 1: The maximal oxygen consumption (VO2 max) is different (ΔVO2 max ≥1 ml/kg/min) between treatments in non-obstructive HCM patients
研究概览
简要总结
The overall clinical purpose and the purpose of this study is to reduce the symptomatic burden and arrhythmic complications in patients with HCM. We aim to quantify the effect of Bisoprolol and Verapamil on maximal oxygen consumption (VO2 max), left ventricular end diastolic volume and the incidence of non-sustained ventricular tachycardia in patients with non-obstructive hypertrophic cardiomyopathy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Maximal wall thickness ≥ 15 mm unrelated to hypertension, valve diseases or storage diseases.
- •And one of the following:
- •New York Heart Association – functional class (NYHA) ≥ II
- •A history of NYHA class ≥ II before treatment with BB or CCB
- •Pro-BNP>300 ng/l/35>nmol/l or BNP >100ng/l/>29nmol/l
- •Non-sustained VT (>120 min-1, ≥3 cycles) documented within the last 2 years of screening
排除标准
- •Left ventricular ejection fraction < 50%
- •Significant liver failure, severe valvular disease, bradycardia (40bpm) or hypotension (systolic <100mmHg), other significant comorbidity or risks associated with discontinuation of BB or CCB after individual judgement by the investigators.
- •Unable to understand patient information intellectually or linguistically
- •Unable to perform exercise test.
- •Unable to speak and/or understand Danish.
- •Additional exclusion criteria for CMRI sub-study: 1.Implantable cardioverter defibrillator (any kind): 2.Pacemaker (any kind): 3.Metal implants like to affect image quality: 4.Metal implants that poses a risk during CMRI: 5.Inability to cope with being in the scanner.
- •LVOT gradient >30 mmHg at rest or during Valsalva maneuver after discontinuation of BB or CCB respectively
- •History of LVOT gradient >30 mmHg at rest, during exercise or during Valsalva maneuver.
- •Permanent atrial fibrillation
- •Permanent right ventricular pacing
- •Previous intolerance for Bisoprolol (BB) or Verapamil (CCB)
- •Known present obstructive coronary disease (previous percutaneous coronary intervention is accepted)
- •eGFR < 40 ml/min
- •Fertile women (<50 years) who are pregnant (Positive Plasma-HCG), breastfeeding or not using anticonceptions.
结局指标
主要结局
Phase 1: The maximal oxygen consumption (VO2 max) is different (ΔVO2 max ≥1 ml/kg/min) between treatments in non-obstructive HCM patients
Phase 1: The maximal oxygen consumption (VO2 max) is different (ΔVO2 max ≥1 ml/kg/min) between treatments in non-obstructive HCM patients
Phase 2: The left ventricular enddiastolic volume (LVvol) is different (ΔLVvol ≥3 ml) between treatments in non-obstructive HCM patients.
Phase 2: The left ventricular enddiastolic volume (LVvol) is different (ΔLVvol ≥3 ml) between treatments in non-obstructive HCM patients.
Phase 3: The incidence of non-sustained ventricular tachycardia (NSVT) is different (Hazard ratio ≥ 0.5) between treatments in non-obstructive HCM patients.
Phase 3: The incidence of non-sustained ventricular tachycardia (NSVT) is different (Hazard ratio ≥ 0.5) between treatments in non-obstructive HCM patients.
次要结局
- Sex specific analyses of effect parameters
- Kansas City Cardiomyopathy Questionnaire (KCCQ) score
- New York Heart Association (NYHA) functional classification
- Canadian Cardiovascular Society (CCS)
- Tolerable dose
- Pro-BNP/BNP
- High sensitive Troponin I/Troponin T
- Recovery time during CPET
- VO2 max at anaerobic threshold during CPET
- Percent predicted VO2 max during CPET
- Ventilatory equivalent for carbon dioxide VE/VCO2 during CPET
- Metabolic equivalent of task (METs) during CPET
- Left ventricular end-diastolic dimension during echocardiography
- Myocardial deformation imaging (Strain) during echocardiography
- Left ventricular outflow tract time velocity intergral (VTI) during echocardiography
- Left atrial dimension during echocardiography
- Left ventricular systolic function during CMRI
- Right ventricular dimensions during CMRI
- Right ventricular systolic function during CMRI
- Stroke volume (Aortic flow) during CMRI
- Coronary sinus flow during CMRI
- Dimension of inferior and superior caval vein during CMRI
- Left atrial dimension during CMRI
- Atrial fibrillation (Ambulatory ECG monitoring)
- Estimation of ventricular ectopic beats (Ambulatory ECG monitoring)