HF Patients With LVADs Being Treated With SGLT2i

Phase 4

Recruiting

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Other: No SGLT2i; Drug: SGLT2i

• Registration Number: NCT05278962
• Lead Sponsor: University of Chicago

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-15
• Study Start: 2022-09-08
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No SGLT2i	No SGLT2i	Participants will not be asked to take an SGLT2i. Heart failure care will be managed according to routine care, and data will be collected from the participant's medical record.
SGLT2i	SGLT2i	Participants will be asked to take an SGLT2i for 6 months. The SGLT2i and heart failure care will be managed according to routine care, and data will be collected from the participant's medical record.

Primary Outcome Measures

Name	Time	Method
Change in number of ramp stages needed to achieve hemodynamic optimization	6 months	Measured by echocardiography

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States