2023-507029-40-00招募中3 期
EARLY treatment with Candesartan vs Placebo in asymptomatic GENEtic carriers of Dilated Cardiomyopathy (EARLY-GENE trial)
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda41 个研究点 分布在 2 个国家目标入组 320 人开始时间: 2023年8月25日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
- 入组人数
- 320
- 试验地点
- 41
- 主要终点
- Proportion of participants that progress to either a LVEF or LVEDV deterioration of ≥10% with respect to the baseline value at the end of follow-up as measured by MRI
研究概览
简要总结
To assess if early administration of candesartan (compared to placebo) prevents either a significant Left ventricular ejection fraction (LVEF) decline of ≥10%, or a ventricular dilatation (left ventricular end-diastolic volume, LVEDV) increase of ≥10% in genetic carriers of a DCM-causing variant without disease expression.
研究设计
- 分配方式
- Randomized
- 主要目的
- Main treatment trial period
- 盲法
- Double (Monitor, Investigator, Carer, Subject, Analyst)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
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
结局指标
主要结局
Proportion of participants that progress to either a LVEF or LVEDV deterioration of ≥10% with respect to the baseline value at the end of follow-up as measured by MRI
Proportion of participants that progress to either a LVEF or LVEDV deterioration of ≥10% with respect to the baseline value at the end of follow-up as measured by MRI
次要结局
- Proportion of participants that progress to a LVEF deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI
- Proportion of participants that progress to a LVEDV deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI.
- Changes in LVEF measured by MRI (vs baseline)
- Changes in LVEDV measured by MRI (vs baseline)
- Proportion of individuals who develop DCM (LVEF<50%)
- Proportion of participants in each treatment group developing Serious Adverse Events (SAEs), Grade 3-4 adverse events (AEs), Adverse Reactions, or AEs of Special Interest (AESIs)
- Proportion of treatment discontinuations in the candesartan and placebo groups
研究者
研究点 (41)
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