A Proof of concept study to investigate the effect of the antiviral medication Telbivudine in patients with inflammatory heart muscle disease caused by the Parvovirus

Phase 1

• Conditions: Parvovirus B19-induced inflammatory cardiomyopathy; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-004825-17-DE
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-09
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

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
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

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
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified