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Completed

NCT Number: NCT05278962

HF Patients With LVADs Being Treated With SGLT2i

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • LVAD implantation
  • Have not already been prescribed management with an SGLT2i
  • Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters(ml)/minute(min)/1.73 meter(m)2
  • Age ≥ 18 years-old
  • Able to provide informed consent

Exclusion criteria

  • Diagnosis of Type 1 diabetes mellitus
  • eGFR < 30 ml/min/1.73 m2
  • Age < 18 years-old

Treatment and study plan

SGLT2i

Drug

empagliflozin (10 mg daily) or dapagliflozin (10 mg daily), depending on formulary coverage

No SGLT2i

Other

No SGLT2i

Primary outcomes

  1. Change in Left Ventricular End-diastolic Dimension (LVEDD)

    Time frame: 6 months after pre-LVAD

Secondary outcomes

  1. Weight Change

    Time frame: 6 months after pre-LVAD

  2. Diuretic Dose

    Time frame: 6 months after pre-LVAD

    Diuretic Dose at 6 months in PO lasix equivalents

  3. LVEF (Left Ventricular Ejection Fraction)

    Time frame: 6 months after pre-LVAD

  4. RV (Normal Right Ventricular) Size

    Time frame: 6 months after pre-LVAD

  5. Creatitine

    Time frame: 6 months after pre-LVAD

  6. ALT (Alanine Aminotransferase/SGPT)

    Time frame: 6 months after pre-LVAD

  7. AST (Aspartate Aminotransferase/SGOT)

    Time frame: 6 month after pre-LVAD

  8. Total Bilirubin (Bili)

    Time frame: 6 month after pre-LVAD

  9. Alk Phos (Alkaline Phosphatase/ALP)

    Time frame: 6 month after pre-LVAD

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2022
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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