跳至主要内容
临床试验/EUCTR2015-003521-34-FR
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

发起方
CHU de Bordeaux

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