HF Patients With LVADs Being Treated With SGLT2i

Last updated: September 11, 2024
Sponsor: University of Chicago
Overall Status: Active - Recruiting

Phase

4

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

SGLT2i

No SGLT2i

Clinical Study ID

NCT05278962
IRB21-1986
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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)/1.73meter(m)2

  4. Age ≥ 18 years-old

  5. Able to provide informed consent

Exclusion

Exclusion Criteria:

  1. Diagnosis of Type 1 diabetes mellitus

  2. eGFR < 30 ml/min/1.73 m2

  3. Age < 18 years-old

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: SGLT2i
Phase: 4
Study Start date:
September 08, 2022
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

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