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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in number of ramp stages needed to achieve hemodynamic optimization

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,733 Total Patients Enrolled

12 Trials studying Heart Failure

1,458 Patients Enrolled for Heart Failure

Mark Belkin, MDPrincipal InvestigatorUniversity of Chicago

Gene Kim, MDPrincipal InvestigatorUniversity of Chicago

1 Previous Clinical Trials

28 Total Patients Enrolled

1 Trials studying Heart Failure

28 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this research project still available to individuals?

"As per clinicaltrials.gov, this experiment is presently enrolling patients. It was initial listed on September 8th 2022 and had its latest revision occur in November 11th 2022."

Answered by AI

How many volunteers are contributing to the research for this pharmaceutical experiment?

"Affirmative, resources on clinicaltrials.gov suggest that this medical experiment is currently recruiting volunteers. It was initially submitted to the database on September 8th 2022 and last edited on November 11th 2022 with a target pool of 44 participants from 1 site."

Answered by AI

Could you elaborate on the potential risks associated with SGLT2i?

"There is no shortage of evidence proving the safety and efficacy of SGLT2i, which has led to it receiving a score of 3 on our risk assessment scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HF Patients With LVADs Being Treated With SGLT2i

2022. "HF Patients With LVADs Being Treated With SGLT2i". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05278962.