← Back to Search

SGLT2 inhibitor

SGLT2 Inhibitors for Heart Failure With LVADs

Phase 4

Recruiting

Led By Mark Belkin, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have not already been prescribed management with an SGLT2i

Age ≥ 18 years-old

Must not have

eGFR < 30 ml/min/1.73 m2

Diagnosis of Type 1 diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study the effects of SGLT2i in HF patients with LVADs to see if it improves outcomes.

Who is the study for?

This trial is for adults over 18 with heart failure who have a left ventricular assist device (LVAD) implanted and haven't been treated with SGLT2 inhibitors yet. They must be able to consent and have an eGFR of at least 30 ml/min/1.73 m². Those with Type 1 diabetes or worse kidney function can't join.

What is being tested?

The study is looking at the effects of sodium-glucose co-transporter 2 inhibitors (SGLT2i) on patients with heart failure who use LVADs, comparing those who take SGLT2i against those who do not.

What are the potential side effects?

Potential side effects of SGLT2 inhibitors may include urinary tract infections, dehydration, low blood pressure, ketoacidosis (a serious condition related to diabetes), and possible kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have not been treated with SGLT2 inhibitors.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is severely reduced.

Select...

I have been diagnosed with Type 1 diabetes.

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in number of ramp stages needed to achieve hemodynamic optimization

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: SGLT2iActive Control1 Intervention

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.

Group II: No SGLT2iActive Control1 Intervention

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.

0 / 5Eligibility criteria met