CTIS2023-507029-40-00招募中1 期
EARLY treatment with Candesartan vs Placebo in asymptomatic GENEtic carriers of Dilated Cardiomyopathy (EARLY-GENE trial) - EARLY-GENE
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda0 个研究点目标入组 320 人开始时间: 2023年8月22日最近更新:
适应症
试验速览
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 64（—）
- 性别
- All
入选标准
- •Age: 18-64 (both included), both sexes, Carrier of a pathogenic or likely pathogenic DCM genetic variant according to modified American College of Medical Genetics (ACMG) criteria, Baseline LVEF = 50% measured by MRI evaluated by the eligibility study committee. Carriers with myocardial fibrosis, detected by late gadolinium enhancement in magnetic resonance, are valid., Baseline potassium = 5.3 mEq/L, creatinine = 1.3 mg/dL and an estimated Glomerular Filtration Rate (eGFR)= 60 ml/min/1.73 m2, Able to understand and accept the study constraints and to provide informed consent.
排除标准
- •Hypotension (systolic arterial pressure <100 mmHg), Presence of any contraindications to receive candesartan treatment, including severe liver failure and/or cholestasis, Known bilateral renal artery stenosis, Uncontrolled concomitant severe disease (e.g., with expected survival inferior to the duration of the study follow-up), Participation in another clinical trial using an investigational medicinal product or device, in the 30 days prior to the inclusion in the study, Current pregnancy, breastfeeding, or women of childbearing age who are not willing to practice an adequate birth control during the duration of the study (a negative pregnancy test result must be obtained at the time of enrolment), Drug or alcohol abuse (current), Inability to adequately comply with study procedures and treatments, Carriers of MRI incompatible internal devices (ICD, pacemakers, aneurysm clips, etc.) or with known intolerance to MRI studies, Any circumstances that in the investigator’s opinion compromise the participant’s ability to participate in the clinical trial, Prior ventricular dysfunction (LVEF = 50% at any time prior to study inclusion), Candidates who are expected or highly likely to receive an implantable cardioverter defibrillator (ICD) in the following 12 months after inclusion in the trial, Preexisting hypertension requiring pharmacological treatment, Uncontrolled arterial hypertension (i.e., repeatedly systolic arterial pressure = 140 mmHg), Carriers of TTN-truncating variants (TTNtv) who are < 35 years old, Known, clinically significant coronary artery disease (=70% stenosis in any epicardial artery or =50% of left main coronary artery), valvular disease (= moderate in severity) or ventricular arrhythmias, Ongoing treatment with ACE inhibitors, ARB, ARNI, MRA, Prior intolerance to ACE inhibitors or ARB
研究者
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