Parvovirus B19-induced inflammatory cardiomyopathy
Conditions
Interventions
Trade Name: Sebivo
Product Name: Sebivo
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main trial objective is to explore the efficacy of Telbivudine as a treatment for Parvovirus-induced inflammatory cardiomyopathy. It is expected that Telbivudine improves symptoms and cardiac functions. Further molecular studies within the trial will test the mechanism of action, whether it is B19 replication inhibition or whether there exist different/other mechanisms. Based on the results of the PreTOPIC study, Telbivudine will be classified as promising or not promising for further investigations in future large scale clinical trials.;Secondary Objective: The secondary trial objective is to demonstrate the safety of Telbivudine as a treatment for Parvovirus-induced inflammatory cardiomyopathy. Safety is considered as a secondary objective in the trial, since Telbivudine will be investigated at the same dose and regimen used for the approved indication, which has been shown to be safe.;Primary end point(s): The primary end point is the improvement of the patient's quality of life (QoL). QoL change will be assessed via the Minnesota Living with Heart Failure Questionnaire (MLWHFQ).;Timepoint(s) of evaluation of this end point: MLWHFQ: At baseline visit (day zero) and after 12 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Left ventricular ejection fraction •Left ventricular end diastolic diameter •Left ventricular global longitudinal systolic strain and systolic strain rate •The 6-minute walk test •New York Heart Association classification •Reduction in the number of angina/chest discomfort episodes •Parvovirus B19 replication; mRNA/DNA loads •Myocardial inflammatory status (CD3+ cells) •Skeletal muscle inflammatory status (CD3+ cells) Safety endpoints: Registration of exercise related adverse events and laboratory changes (Blood examination including (sodium, potassium, creatinine, haemoglobin, white and red blood cell counts, thrombocytes count, Nt-proBNP, creatine kinase MM and MB, Cardiac Troponin T, AST, ALT). ;Timepoint(s) of evaluation of this end point: •LVEF: at baseline (D0±1), week 12 •LVEDD: at baseline (D0±1) and week 12 •6MWT: at baseline (D0±1) and week 12 •NYHA classification: at baseline (D0±1) and at weeks 4,8, 12 •Number of angina/chest discomfort episodes: at baseline (D0±1) and weeks 4,8, 12 •Biopsy; B19 RNA/cDNA; CD3+ lymphocytes: at week 12 • Skeletal muscle biopsy: at baseline (D0±1) and at week 12 Safety endpoints (hematological and clinical laboratory analysis): Before the start of treatment (D0-X)±1) and at baseline (D0±1), week 4,8, 12 | — |
Countries
Germany
Contacts
Public ContactBCRT-Clinical Development Platform
Charité Universitätsmedizin Berlin
Outcome results
None listed