Heart Failure With Reduced Ejection FractionPhase 4NCT05278962
HF Patients With LVADs Being Treated With SGLT2i
A Phase 4 study testing SGLT2i and No SGLT2i in people with Heart Failure With Reduced Ejection Fraction, run by University of Chicago at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- SGLT2i and No SGLT2i
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2022to 31 Aug 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of Type 1 diabetes mellitus
- eGFR < 30 ml/min/1.73 m2
- Age < 18 years-old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Failure Patients With Left Ventricular Assist Devices Being Treated With Sodium-Glucose Co-Transporter 2 Inhibitors
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).
Read the detailed 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.
- Being tested
- SGLT2i, No SGLT2i
- Keywords
- left ventricular assist device, SGLT2i
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2iDrug
empagliflozin (10 mg daily) or dapagliflozin (10 mg daily), depending on formulary coverage
No SGLT2iOther
No SGLT2i
| Study group | Role | What they receive |
|---|---|---|
| SGLT2i | Active comparator | 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. Receives: Drug: SGLT2i |
| No SGLT2i | Active comparator | 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. Receives: Other: No SGLT2i |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular End-diastolic Dimension (LVEDD)
Measured: 6 months after pre-LVAD
Secondary outcomes (9)
Weight Change
Measured: 6 months after pre-LVAD
Diuretic Dose
Diuretic Dose at 6 months in PO lasix equivalents
Measured: 6 months after pre-LVAD
LVEF (Left Ventricular Ejection Fraction)
Measured: 6 months after pre-LVAD
RV (Normal Right Ventricular) Size
Measured: 6 months after pre-LVAD
Creatitine
Measured: 6 months after pre-LVAD
ALT (Alanine Aminotransferase/SGPT)
Measured: 6 months after pre-LVAD
AST (Aspartate Aminotransferase/SGOT)
Measured: 6 month after pre-LVAD
Total Bilirubin (Bili)
Measured: 6 month after pre-LVAD
Alk Phos (Alkaline Phosphatase/ALP)
Measured: 6 month after pre-LVAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start8 Sep 2022
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Belkin, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278962
- Sponsor's protocol ID
- IRB21-1986
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2022
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Patients With Left Ventricular Assist Devices Being Treated With Sodium-Glucose Co-Transporter 2 Inhibitors
- ClinicalTrials.gov ID
- NCT05278962
- Acronym / sponsor ID
- IRB21-1986
- Keywords
- left ventricular assist device, SGLT2i
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Posted 8 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2i | Active comparator | Drug: SGLT2iParticipants 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. |
| No SGLT2i | Active comparator | Other: No SGLT2iParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosis of Type 1 diabetes mellitus
- eGFR < 30 ml/min/1.73 m2
- Age < 18 years-old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2iempagliflozin (10 mg daily) or dapagliflozin (10 mg daily), depending on formulary coverage | Drug | SGLT2i |
| No SGLT2iNo SGLT2i | Other | No SGLT2i |
Primary outcome
Change in Left Ventricular End-diastolic Dimension (LVEDD)
Time frame: 6 months after pre-LVAD
9 secondary outcomes
Weight Change
Time frame: 6 months after pre-LVAD
Diuretic Dose
Time frame: 6 months after pre-LVAD
LVEF (Left Ventricular Ejection Fraction)
Time frame: 6 months after pre-LVAD
RV (Normal Right Ventricular) Size
Time frame: 6 months after pre-LVAD
Creatitine
Time frame: 6 months after pre-LVAD
ALT (Alanine Aminotransferase/SGPT)
Time frame: 6 months after pre-LVAD
AST (Aspartate Aminotransferase/SGOT)
Time frame: 6 month after pre-LVAD
Total Bilirubin (Bili)
Time frame: 6 month after pre-LVAD
Alk Phos (Alkaline Phosphatase/ALP)
Time frame: 6 month after pre-LVAD
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Belkin, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SGLT2i and No SGLT2i in people with Heart Failure With Reduced Ejection Fraction, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular End-diastolic Dimension (LVEDD) (time frame: 6 months after pre-LVAD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.