Heart failure and type 2 diabetes mellitus MedDRA version: 20.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: PT Classification code 10007554 Term: Cardiac failure System Organ Class: 10007541 - Cardia
Conditions
Interventions
Trade Name: JARDIANCE - 10 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 28 COMPRESSE
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: empagliflozin
Current Sponso
Sponsors
FONDAZIONE TOSCANA GABRIELE MONASTERIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of type 2 diabetes mellitus with HbA1c =7.0% and =10.0%, on stable pharmacological therapy for at least one month; - Heart failure (diagnosed according to Framingham criteria) with left ventricular dysfunction (defined as left ventricular ejection fraction - EF =65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: - Patients with acute coronary syndromes, coronary revascularization, valvular surgery or resynchronization therapy in the previous 3 months; - Patients with type 1 diabetes mellitus (with undetectable C-peptide serum levels) or diabetes secondary to pancreasectomy, history of diabetic ketoacidosis, at least one episode of severe hypoglycemia in the previous 6 months; - Patients treated with pioglitazone or saxagliptin; - Severe obesity (BMI >40kg/m2); - Clinical history of recurrent or severe genitourinary infections; - Active malignancies; - Patients with estimated life expectancy <1 year; - Patients with significant hepatic function abnormalities (defined as ALT/AST elevation of more than 3-fold the upper limit of reference values or elevation of total bilirubin more than 1,5-fold the upper limit of reference values, without diagnosis of Gilbert’s Syndrome); - Uncontrolled thyroid disease; - Known or suspected allergy to the drugs subjected to investigation or to one or more of the excipients; - Pregnant, breast-feeding women or fertile women who do not follow an adequate contraception (all women must consent to abstinence from heterosexual-intercourse, or adopt any two of the following contraceptive measures considered efficacious as: bilateral tube ligation, male sterilization, use of hormonal contraceptives that inhibit ovulation, copper intrauterine devices; every barrier device must be used together with a spermicide cream); - Inability to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Test the effects of empagliflozin on neuro-hormonal activation, as exstimated by 1-year variation in NT-proBNP plasma concentrations;Secondary Objective: - Test the effects of empagliflozin on left ventricular remodeling, defined as variations in endsystolic and end-diastolic left ventricular volumes at 1-year transthoracic echocardiographic follow-up. - Test the effects of empagliflozin on adrenergic and renin-angiotensin-aldosterone systems activation. - Test the effects of empagliflozin on exercise capacity, measured as peak oxygen consumption at cardiopulmonary test.;Primary end point(s): 1-year variation in NT-proBNP plasma concentrations;Timepoint(s) of evaluation of this end point: 1 YEAR | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-year variations in exercise capacity, measured as peak oxygen consumption at cardiopulmonary test;Timepoint(s) of evaluation of this end point: 1 YEAR | — |
Countries
Italy
Contacts
Public ContactU.O.C. Farmaceutica Ospedaliera
Fondazione Toscana Gabriele Monasterio
Outcome results
None listed