CTIS2023-505048-20-00进行中（未招募）1 期
BLOCKADE OF THE RENIN-ANGIOTENSIN-ALDOSTERONE SYSTEM IN PATIENTS WITH ARVD: A DOUBLE-BLIND MULTICENTRE PROSPECTIVE RANDOMIZED STUDYBRAVE - 69HCL18_0038
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Adult patient= 18 years, Diagnosis of ARVD based on Task Force criteria. Two major criteria: 1 morphologic and one rhythmic or 1 major and 2 minor criteria established by the European Society of Cardiology/International Society and Federation of Cardiology, Increased right ventricular volume (> 100ml/m² female; > 110ml/m² male)., LVEF >40%, Signed written informed consent
排除标准
- •Patients under judicial protection, Normal right ventricular volume, Heart transplantation, Swallowing disorders, Participation in any other interventional clinical investigation that may have an impact on our study, Female patient who is pregnant or lactating, or is of child bearing potential (defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if = 55 years or 12 months if > 55 years) and who did not agree to use highly effective methods of birth control throughout the study., No health insurance, Right heart failure patient (RV volume>150ml), Spironolactone contraindication, Mandatory indication for a combination of ACE inhibitor and sartan or renin inhibitor (each authorized separately), Acute phase of systemic disease, Uncompensated hypothyroidism, Acute hyperthyroidism
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