EUCTR2016-004825-17-DE
Active, not recruiting
Phase 1
A Proof-of-concept study to investigate the Efficacy of Telbivudine Over Placebo in patients with Parvovirus-associated Inflammatory Cardiomyopathy - preTopic
ConditionsParvovirus B19-induced inflammatory cardiomyopathyTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsSebivo
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Parvovirus B19-induced inflammatory cardiomyopathy
- Sponsor
- Charité Universitätsmedizin Berlin
- Enrollment
- 25
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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