EUCTR2015-003521-34-FR进行中(未招募)不适用
Hypertrophic CARdiomyopathy symptom release by alpha stimulant MIDOdrine - Light-CARMIDO
CHU de Bordeaux0 个研究点开始时间: 2015年9月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adults aged 18-80 years of both sexes,
- •- Patients carrying a typical or atypical hypertrophic cardiomyopathy diagnosed by cardiac imaging (echocardiography and MRI) and / or genetic testing or family history,
- •- Obstruction per-effort treadmill (in aortic obstruction> 50 mmHg measured continuously aligned with the Doppler aortic ejection)
- •- Positive response (<50 mmHg obstruction) test Leg-lifting of rest and / or immediate post-exercise
- •- Symptomatic to stress in daily life: dyspnea NYHA 2-3, non coronary chest pain, fainting effort,
- •- Exploitable ultrasonic window,
- •- Sinus rhythm,
- •- Optimal medical treatment,
- •- For women of childbearing potential, effective contraception and required negative pregnancy test,
- •- Intent Consent form signed by the patient after having read the information letter,
- •- Patient affiliated to national health system.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Minor Patient,
- •- Taking Gutron® earlier,
- •- Extra-cardiac pathology limiting life expectancy to less than a year,
- •- Inability to consent or refusal to sign the consent,
- •- Pregnant and breastfeeding women,
- •- Hypertrophy secondary to hypertensive or valvular disease,
- •- Permanent atrial fibrillation,
- •- Threatening ventricular rhythm disorders (ventricular doublets, bigeminy, bursts TV) without a pacemaker,
- •- Severe Coronary Artery Disease,
- •- Hypertension unbalanced by the usual therapeutic,
- •- Severe heart disease (Fe <40% or severe elevated filling pressures, pulmonary hypertension> 60 mmHg)
- •- Narrow Angle Glaucoma,
- •- Obliterative vasculopathy severe,
- •- Vasospasm,
- •- Thyrotoxicosis,
- •- Pheochromocytoma,
- •- Severe renal impairment <30ml / min,
- •- Raynaud's disease,
- •- History of CHD pain,
- •- Non-selective MAO inhibitors (iproniazid, nialamide) or indirect sympathomimetic (ephedrine, methylphenidate, phenylephrine, pseudoephedrine), or digitalis,
- •- Any procedure modifying the venous return: vein stripping / venotomy the lower limbs,
- •- Participation in another biomedical research study,
- •- Criteria relating to the regulation: persons under safeguard justice, physical and / or psychological severely impaired, which according to the investigator, may affect the compliance of participating in the study
研究者
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