Study on the effect of dapagliflozin on myocardial insulin sensitivity and perfusion (DapaHeart) - DAPA HEART

IVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI0 sites52 target enrollmentFebruary 8, 2018

Overview

No summary available.

Registry

who.int

Start Date

February 8, 2018

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

IVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

•1\. Provision of informed consent prior to any study specific procedures
•2\. Female or male subjects aged between 40 and 75 inclusive.
•? Patients who have been surgically sterilized (hysterectomy or tubal\-ligation) at least 12 months prior to screening, or
•? are postmenopausal having had no regular menstrual bleeding for at least one (1\) year prior to screening. Menopause will be confirmed by a plasma follicle stimulating hormone (FSH) level of \> 35 IU/mL at screening, or
•? Women with childbearing potential willing not to start a pregnancy during the course of the study and non\-nursing women
•? Men having relationships with women with childbearing potential willing not to procure a pregnancy during the course of the study;
•3\. Patients with type 2 diabetes
•4\. Patients with established, stable CAD, defined as \=30% coronary stenosis in at least one major coronary vessel on invasive coronary angiography (ICA) or computed tomography angiography (CTA) performed within 12 months from screening and no indication to revascularization
•5\. Patients with a clinical indication for 13N\-ammonia PET\-CT, as established by a cardiologist, nuclear medicine physician or diabetologists
•6\. Patients with a body mass index (BMI) equal or greater than 25 kg/m2 but less than 35 kg/m2 \[BMI \= Weight (kg) / Height squared (m2\)]

•1\. Type 1 diabetes (as assessed by medical history); previous diagnosis of Latent Autoimmune Diabetes of Adults (LADA), and or not fulfilling inclusion criteria \#10
•2\. History of diabetic ketoacidosis or hyperosmolar non ketotic coma
•3\. NYHA class III or IV
•4\. Unstable angina
•5\. Previous re\-vascularisation (either percutaneous coronary intervention or coronary artery bypass graft)
•6\. Reduced left ventricular ejection fraction (\=50%)
•7\. Increased likelihood of developing diabetic ketoacidosis (history of DKA, alcohol consumption, volume depletion dehydration, clinical conditions causing diarrhea, vomit and anorexia)
•8\. Moderate to severe renal impairment (eGFR\<60 ml/min/1\.73m2 as calculated by the modification of diet in renal disease \[MDRD] equation or end\-stage renal disease); overt proteinuria, defined as Spot urine Microalbumin/Cr ratio of \>300 mg/g at screening (Visit 0\)
•9\. Severe liver dysfunction
•10\. Asthma