virus negative inflammatory cardiomyopathy MedDRA version: 20.0 Level: PT Classification code 10007636 Term: Cardiomyopathy System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: DELTACORTENE - 25 MG COMPRESSE 10 COMPRESSE
Product Name: prednisone
Product Code: [na]
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Current Sponsor code
Sponsors
UMBERTO I - POLICLINICO DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women over the age of 18 years old 2) Signing of the informed consent 3) Chronic heart failure (NYHA class = II) lasting > 6 months 4) Dilation (left ventricular end-diastolic diameter more than 57 mm) and dysfunction (ejection fraction less than 45%) of the left ventricle. 5) Histologic (Dallas criteria) and immunohistochemical diagnosis of myocarditis, defined by the presence of at least 7/mm2 cluster of differentiation 3 (CD3) positive lymphocytes and/or at least 14 infiltrating leucocytes (LCA+ cells)/mm2 in the specimen, associated with necrosis of the adjacent cardiomyocytes. 6) Absence of cardiotropic viruses, as defined by polymerase chain reaction analysis for a wide panel of viral agents (i.e. adenovirus, enterovirus as echoviruses and coxsackie viruses, influenza virus A and B, HCV, herpes simplex virus 1 and 2, Cytomegalovirus, EBV, Parvovirus B19, Human Herpes Virus 6) and of bacterial agents (Borrelia burgdorferi) . The test must have been performed no more than 2 weeks prior to the inclusion in the study 7) Absence of valvular and/or coronary artery disease that can justify the severity of cardiac dysfunction 8) Negative blood pregnancy test in fertile females and usage of the highly effective method of contraception (hormonal or 2 barrier method of contraception). A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. 9) Clinical progression of the disease despite anti-heart failure therapy from more than six months, including digitalis, diuretics, ACE inhibitors, and Carvedilol. 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Recent (less than 6 months) onset of systolic heart failure, all known causes of heart failure (such as hypertension, significant coronary artery disease, valvular heart diseases), 2. Endocrine disease (tiroid, adrenal and hypophysis dysfunction),, significant renal disease (diseases causes creatinine clearance < 60 ml/min),, drug or alcohol abuse 3. Pregnancy and lactation 4. Therapy with steroids within the 6 months before the study 5. All contraindications of immunosuppressive therapy according to Summary of product characteristics (SmPC) of both investigational medicinal products 6. The refusal of a patient to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The improvement in the ejection fraction = 10%.;Secondary Objective: 1) Reduction in mortality (cardiac death or heart transplantation) and in the rate of readmission to the hospital 2) Reduction of left ventricular end-diastolic volume 3) Evaluation of the modifications on cardiac histopathologic findings 3) Analysis of the variations of the immunologic profile (anti-heart autoantibodies, pattern Th1 or Th2 of the circulating lymphocytes) 4) Evaluation of the effect on the expression of the genes implicated in the cardiac reparative processes 5) Assessment of the level of cell death (apoptosis, necrosis, autophagy) and cell proliferation (ckit positive stem cells, cycling cardiomyocytes, lineage-committed cells). ;Primary end point(s): 1)Improvement in left ventricular function, based on the enhancement of ejection fraction. The patients will be defined as responders in presence of an improvement in ejection fraction of at least 10%. ;Timepoint(s) of evaluation of this end point: At the end of the study (six months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Reduction in mortality (cardiac death or heart transplantation) and in the rate of readmission to the hospital 2) Reduction of left ventricular end-diastolic volume. 3) Improvement in heart failure symptoms (evaluated as reduction in NYHA class) 4) Evaluation of the modifications on cardiac histopathologic findings 5) Analysis of the variations of the immunologic profile (anti-heart autoantibodies, pattern Th1 or Th2 of the circulating lymphocytes) 6) Evaluation of the effect on the expression of the genes implicated in the cardiac reparative processes 7) Assessment of the level of cell death (apoptosis, necrosis, autophagy) and cell proliferation (ckit positive stem cells, cycling cardiomyocytes, lineage-committed cells) in baseline cardiac dysfunction and in follow-up. ;Timepoint(s) of evaluation of this end point: At the end of protocol (six months) | — |
Countries
Italy
Contacts
Public Contactcoordinatore della sperimentazione
Dip. di Scienze cardiovascolari
Outcome results
None listed