Hypertrophic Cardiomyopathy Symptom Release by BX1514M
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change from baseline at day 15 of covered distance during the 6 minutes walk distance test (6MWT)
研究概览
简要总结
Hypertrophic cardiomyopathy (HCM) is the most frequent genetic cardiac disease characterized by an asymmetric hypertrophic. In two third of patients, an obstruction to blood ejection is observed within the left ventricle which is named left ventricular outflow tract obstruction (LVOTO). This phenomenon can occur at rest or during exercise and is associated with symptoms such as dyspnea, dizziness or chest pain that can significantly limit day life adaptation. To now, medical or interventional treatments such as betablocacker, calcium blockers or septal alcoholisation or surgery present with a limited efficiency. Recent studies from investigators group revealed new concepts about the role of venous return to the LVOTO. Therefore the investigators hypothesis that BX1514M generating a venous vascular constriction, could improve symptoms of HCM patients by reducing LVOTO.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a typical or atypical hypertrophic cardiomyopathy (HCM) confirmed by imaging modalities (echo and MRI) and/or genetic tests or a relative history of HCM
- •Left ventricular obstruction during exercise on treadmill (above 50 mmHg)
- •Positive response to leg lifting test (obstruction reduction above 20 mmHg) at rest or in early recovery phase
- •Daily symptoms as shortness of breath during exercise (NYHA2-3), non coronary chest pain, dizziness
- •Correct ultrasound windows quality
- •Sinus rhythm
- •Optimal medical treatment
- •For women, pregnancy test or contraception
- •Written consent form obtained
排除标准
- •Previous treatment by BX1514M
- •Extra-cardiac pathology with life expectancy below than 1 year
- •No capability of consent form written
- •Pregnancy women
- •Secondary hypertension hypertrophy, secondary valvular disease hypertrophy
- •Permanent atrial fibrillation
- •Severe ventricular arrhythmia without Implantable Cardioverter Defibrillator (ICD)
- •Severe coronary disease
- •Severe non stabilized hypertension
- •Severe cardiopathy (ejection fraction below 40% or demonstrated elevated end diastolic pressure or pulmonary pressure above 60 mmHg)
- •Bradycardia
- •Narrow angle glaucoma
- •Vascular prethrombotic diseases
- •Vascular spams
- •Thyrotoxicosis
- •Pheochromocytoma
- •Severe renal failure (<30ml/mn)
- •Patients at risk of urinary retention secondary to prostatic severe disease
- •Raynaud's disease
- •Non selective Monoamine Oxidase Inhibitors (MAOIs), iproniazid, nialamide or ephedrine, methylphenidate, phenylephrine, pseudoephedrine or digitalic
- •Procedures modifying the peripheral venous return
- •Participation to other research protocol
研究组 & 干预措施
Placebo group
20 patients
干预措施: Placebo (Drug)
Treatment group
20 patients
干预措施: Treatment BX1514M (Drug)
Treatment group
20 patients
干预措施: Walk distance test (Other)
Treatment group
20 patients
干预措施: Exercise echocardiography (Other)
Placebo group
20 patients
干预措施: Walk distance test (Other)
Placebo group
20 patients
干预措施: Exercise echocardiography (Other)
结局指标
主要结局
Change from baseline at day 15 of covered distance during the 6 minutes walk distance test (6MWT)
时间窗: Day 15
In meters
次要结局
- Covered distance during the 6 minutes walk distance test (6MWT)(Day 30)
- Exercise echocardiography with measures of blood pressures in the rest and in the effort(Day 1, day 15, day 30)