EUCTR2016-002225-10-IT
Active, not recruiting
Phase 1
Impact of empagliflozin on left ventricular functions: a single center, phase III, randomized, open-label, active treatment-controlled, parallel study in patients with type 2 diabetes and normal left ventricular function - EMPA-HEART
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- type 2 diabetes
- Sponsor
- AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
- Enrollment
- 75
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male of female patients affected by type 2 diabetes mellitus (T2DM)
- •Subjects aged \>40 and \<80 years
- •HbA1c levels \=53 and \= 69 mmol/mol
- •Assuming stable hypoglycemic therapy since three months with:
- •Metformin \+ basal insulin
- •Assuming stable cardio\-active therapies since three months (anti\-hypertensive drugs, diuretics, drugs for asthma, drugs for migraine)
- •With preserved kidney function as defined by eGFR \=45 ml.min\-1\.1\.73m2
- •With preserved left ventricular function as defined by (NYHA class 1\-2, and EF\=50%)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •Refuse to give or inability to give informed consent;
- •Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
- •Employees of the investigator or study centre (i.e., principal investigator, sub\-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator;
- •Patients with type 1 diabetes mellitus;
- •Pregnancy or active breast feeding;
- •History of acute coronary syndrome;
- •Respiratory insufficiency or history of clinically significant respiratory diseases (chronic obstructive pulmonary disease);
- •Acute or chronic inflammatory diseases;
- •History of active neoplastic disease within the last 5 years;
- •Patients with known hypersensitivity to empagliflozin and its excipients;
Outcomes
Primary Outcomes
Not specified
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