EUCTR2016-004825-17-DE进行中（未招募）1 期
A Proof-of-concept study to investigate the Efficacy of Telbivudine Over Placebo in patients with Parvovirus-associated Inflammatory Cardiomyopathy - preTopic
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
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 18–75 years
- •Men and women
- •Symptomatic heart failure in NYHA II/III stage
- •LVEF = 50% (during the previous 3 months despite at least 6 weeks of heart failure treatment)
- •Active B19 (mRNA positive) in endomyocardial
- •Symptomatic heart failure therapy at stable doses for = 6 weeks
- •Patients being capable of understanding the nature, importance, and scope of the clinical trial and being able to give written informed consent
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Recent cardiac surgery in = 6 weeks
- •Major adverse cardiac events (MACE) = 6 weeks (e.g. ICD shock, myocardial infarction, stroke, revascularization)
- •Cardiovascular procedure or hospitalization planned in the future
- •Coronary artery disease (CAD) with need for revascularization
- •Heart failure secondary to significant uncorrected primary valvular disease
- •Co-morbidities associated with reduced life expectancy <1 year
- •Inability to participate in exercise training (e.g. COPD GOLD III-IV, claudication =2b, other functional or mental limitations, significant cardiac ischemia, arrhythmias)
- •Presence of persistent atrial fibrillation
- •EMB examination showing active (mRNA positive) adeno or enterovirus (Coxsackievirus B3)
- •Positive pregnancy test in female study participants
- •Patients who take any of the prohibited concomitant medications: Immunosuppressant agents (e.g.: Corticosteroids, Cyclosporine), Interferon, anti-viral agents (e.g.: Valganciclovir, Lamivudine), and long-acting nitrates (e.g.: Isosorbide di/trinitrate).
- •Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel.
- •Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship).
- •Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- •Patients who are dependent on sponsor, investigator or study site
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