diabetes mellitus and heart failure MedDRA version: 20.0 Level: LLT Classification code 10011949 Term: Decompensation cardiac System Organ Class: 100000004849
Conditions
Interventions
Trade Name: JARDIANCE - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 28 COMPRESSE
Product Name: Jardiance
Product Code: [Jardiance]
Pharmaceutical Form: Film-coated tablet
Sponsors
AOU FEDERICO II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age =18 years; • Post-menopausal women, or no-pregnancy state (documented by pregnancy test); • LVEF = 40% in at least two consecutive transthoracic echocardiographic evaluations; • Stable clinical conditions (NYHA class II-III); • Diagnosis of HF since at least 6 months; • Stable optimal pharmacological HF therapy since at least 6 weeks; • Type 2 DM with an indication to treatment with empagliflozin; • Estimated glomerular filtration rate (eGFR) =30 ml/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) criteria; • Capability to understand the study procedures and sign the informed consent form. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: Age =75 years; • Type 1 DM; • Suspected or known liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal; • Planned cardiac surgery (including heart transplantation) or percutaneous coronary intervention within 3 months; • Acute coronary syndrome, stroke, or transient ischemic attack within 2 months before the inclusion in the study; • Estimated glomerular filtration (eGFR) <30 ml/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) criteria; • Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption; • Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells; • Medical history of cancer and/or treatment for cancer within the last 5 years;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the effects of empagliflozin on myocardial sympathetic nervous system activity trough the assessment of catecholamine behaviors at the synaptic level evaluated by myocardial scintigraphy with I123-metaiodo-benzylguanidine (I123-MIBG);Primary end point(s): To assess the effect of empagliflozin on LV remodeling and function To assess the effects of empagliflozin on biomarkers of HF hemodynamic status, i.e. natriuretic peptides levels, that are associated to prognosis in HF patients;Timepoint(s) of evaluation of this end point: 24 months;Main Objective: To assess the effect of empagliflozin on LV remodeling and function To assess the effects of empagliflozin on biomarkers of HF hemodynamic status, i.e. natriuretic peptides levels, that are associated to prognosis in HF patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the effects of empagliflozin on myocardial sympathetic nervous system activity trough the assessment of catecholamine behaviors at the synaptic level evaluated by myocardial scintigraphy with I123-metaiodo-benzylguanidine (I123-MIBG);Timepoint(s) of evaluation of this end point: 24 Months | — |
Countries
Italy
Contacts
Public ContactDipartimento di Scienze Biomediche
Università degli studi di Napoli Federico II
Outcome results
None listed