EUCTR2021-004577-30-ES进行中（未招募）1 期
EARLY treatment with Candesartan vs Placebo in asymptomatic GENEtic carriers of Dilated Cardiomyopathy (EARLY-GENE trial) - EARLY-GENE
FUNDACION INVESTIGACION BIOMEDICA HOSPITAL PUERTA DE HIERRO MAJADAHONDA0 个研究点目标入组 320 人开始时间: 2021年12月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
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
- •- Age: 18-64 (both included), both sexes
- •- Carrier of a pathogenic or likely pathogenic DCM genetic variant according to the modified American College of Medical Genetics (ACMG) criteria.
- •- Baseline LVEF = 50% measured by MRI evaluated by the eligibility study committee.
- •- 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 (either by themselves or by a legal representative).
- •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 320
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Hypotension (systolic arterial pressure <100 mmHg)
- •- 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.
- •- Presence of any contraindications to receive candesartan treatment, per investigator’s opinion.
- •- 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 (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.
研究者
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