Heart failure patients with LVADs treated with SGLT2 inhibitors
Heart Failure Patients With Left Ventricular Assist Devices Being Treated With Sodium-Glucose Co-Transporter 2 Inhibitors
This study is testing if a diabetes medication can help heart failure patients with LVADs feel better and avoid hospital visits compared to standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05278962 on ClinicalTrials.gov |
What this trial studies
This study aims to observe the outcomes of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in patients with heart failure who have undergone left ventricular assist device (LVAD) implantation. It is a prospective, randomized controlled trial involving 40 patients, who will be assigned to either receive SGLT2i treatment or standard care without it. The hypothesis is that SGLT2i will provide cardiovascular benefits by reducing preload and potentially decreasing heart failure readmissions and right ventricular failure. Data will be collected from medical records over a 6-month period to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone LVAD implantation and have not previously been prescribed SGLT2i.
Not a fit: Patients with Type 1 diabetes mellitus or those with an estimated glomerular filtration rate below 30 ml/min/1.73 m2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and outcomes for heart failure patients with LVADs.
How similar studies have performed: While the specific application of SGLT2i in LVAD patients is novel, other studies have shown cardiovascular benefits of SGLT2i in heart failure populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Mark Belkin, MD — University of Chicago
- Study coordinator: Mark Belkin, MD
- Email: Mark.Belkin@bsd.uchicago.edu
- Phone: 773-702-9500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.