HF Patients With LVADs Being Treated With SGLT2i

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

Heart Failure Patients With Left Ventricular Assist Devices Being Treated With Sodium-Glucose Co-Transporter 2 Inhibitors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05278962
• Other study ID #: IRB21-1986
• Status: Recruiting
• Phase: Phase 4
• Start date: September 8, 2022
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: University of Chicago
• Contact: Mark Belkin, MD
• Phone: 773-702-9500
• Email: Mark.Belkin[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

The exact mechanism of cardiovascular benefit from SGLT2i continues to be the source of further research. The investigators hypothesize that heart failure patients with LVADs will similarly benefit from the SGLT2i-associated natriuresis and diuresis, which in turn reduces preload. This is further associated with reduced heart failure readmissions and right ventricular failure. Additionally, the animal models indicating reduced cardiac work and remodeling in this population may benefit these patients as one of the goals of LVAD implantation is to reduce cardiac energy expenditure and promote remodeling and recovery in these patients.

This is a prospective, randomized controlled study to assess cardiac benefit of SGLT2i in 40 consecutive patients with heart failure undergoing LVAD implantation. After routine LVAD implantation, patients will be randomized 1:1 to one of two routine care arms: management with an SGLT2i [empagliflozin 10 milligram (mg) daily or dapagliflozin 10 mg daily, based on formulary coverage] or no SGLT2i. The patient's treating physician will be able to override randomization assignment if they determine that the assignment is not in the patient's best interest. SGLT2i management (if applicable) and follow-up care will be dictated by routine care. Data will be collected from the subject's medical record for 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Drug:
• SGLT2i
empagliflozin (10 mg daily) or dapagliflozin (10 mg daily), depending on formulary coverage

Other:
• No SGLT2i
No SGLT2i

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of ramp stages needed to achieve hemodynamic optimization	Measured by echocardiography	6 months