2024-517412-29-00招募中3 期
Sacubitril/valsartan in the prevention of disease progression in patients with an ancient arrhythmogenic service - ARNI-ARVC multicentre randomized trial
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy8 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年10月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- the degree of fibrosis of the left ventricular muscle in the CMR examination
研究概览
简要总结
The aim of the ARNI-ARVC study is to assess the anti-fibrotic and antiremodeling effects of sacubitril / valsartan in ARVC.
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
- •certain diagnosis of ARVC based on the 2010 International Task Force Criteria (ITFC) diagnostic criteria
- •age> 18 years
- •expressing a written informed consent to participate in the project
- •Left ventricular ejection fraction (LVEF) ≥ 40% as assessed by CMR.
排除标准
- •contraindications for CMR: - claustrophobia - cochlear implant - ferromagnetic material in tissues
- •symptoms of end-stage right ventricular failure (dyspnoea, massive peripheral edema, enlargement of the liver and abdominal circumference, positive jugular vein pulsation)
- •contraindications to the use of sacubitril / valsartan: - drug intolerance History of angioedema related to prior treatment with an angiotensin converting enzyme inhibitor or an angiotensin II receptor antagonist - hereditary or idiopathic angioedema - hyperkalaemia greater than 5.4 mmol / l - severe hepatic impairment - biliary cirrhosis and cholestasis - Child-Pugh grade C - renal failure with eGFR <30 ml / min / 1.73 m2 - hypersensitivity to the active substances or any of the excipients - taking direct renin inhibitors - pregnancy - lactation.
结局指标
主要结局
the degree of fibrosis of the left ventricular muscle in the CMR examination
the degree of fibrosis of the left ventricular muscle in the CMR examination
left ventricular ejection fraction (LVEF) in CMR
left ventricular ejection fraction (LVEF) in CMR
ventricular arrhythmias load
ventricular arrhythmias load
次要结局
- sudden cardiac death
- NT-proBNP concentration and two fibrosis markers: sST2 and Gal-3
- morphological and functional criteria (ECHO and CMR): the size of the left and right ventricles as well as generalized and focal contractility disorders
- ECG: terminal activation delay (TAD) and extent of negative T waves in precordial leads
- arrhythmias in the ECG, 24-hour Holter ECG recording, ergospirometry and ICD readings
- physical capacity (pVO2) assessed on the basis of ergospirometric tests
- hospitalization for symptoms of heart failure
研究者
Clinical Research Support Centre Information Desk
Scientific
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
研究点 (8)
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