Clinical trial
Heart Failure Patients With Left Ventricular Assist Devices Being Treated With Sodium-Glucose Co-Transporter 2 Inhibitors
Name
IRB21-1986
Description
The main purpose of this study is to observe outcomes of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in heart failure (HF) patients with left ventricular assist devices (LVAD).
Trial arms
Trial start
2022-09-08
Estimated PCD
2024-09-01
Trial end
2024-09-01
Status
Recruiting
Phase
Early phase I
Treatment
SGLT2i
empagliflozin (10 mg daily) or dapagliflozin (10 mg daily), depending on formulary coverage
Arms:
SGLT2i
No SGLT2i
No SGLT2i
Arms:
No SGLT2i
Size
44
Primary endpoint
Change in number of ramp stages needed to achieve hemodynamic optimization
6 months
Eligibility criteria
Inclusion Criteria:
1. LVAD implantation
2. Have not already been prescribed management with an SGLT2i
3. Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters(ml)/minute(min)/1.73 meter(m)2
4. Age ≥ 18 years-old
5. Able to provide informed consent
Exclusion Criteria:
1. Diagnosis of Type 1 diabetes mellitus
2. eGFR \< 30 ml/min/1.73 m2
3. Age \< 18 years-old
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}
Updated at
2023-12-19
1 organization
1 drug
1 indication
Organization
University of ChicagoDrug
SGLT2i