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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT2i | Drug | empagliflozin (10 mg daily) or dapagliflozin (10 mg daily), depending on formulary coverage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular End-diastolic Dimension (LVEDD) | 6 months after pre-LVAD |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change | 6 months after pre-LVAD | |
| Diuretic Dose | Diuretic Dose at 6 months in PO lasix equivalents | 6 months after pre-LVAD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Belkin, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SGLT2i | 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. SGLT2i: empagliflozin (10 mg daily) or dapagliflozin (10 mg daily), depending on formulary coverage |
| FG001 | No SGLT2i | 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. No SGLT2i: No SGLT2i |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SGLT2i | 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. SGLT2i: empagliflozin (10 mg daily) or dapagliflozin (10 mg daily), depending on formulary coverage |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Left Ventricular End-diastolic Dimension (LVEDD) | One patient in SGLT2i arm was lost to follow up. | Posted | Median | Inter-Quartile Range | centimeters (cm) | 6 months after pre-LVAD |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SGLT2i | 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. SGLT2i: empagliflozin (10 mg daily) or dapagliflozin (10 mg daily), depending on formulary coverage |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Belkin | University of Chicago | 773-702-9500 | Mark.Belkin@bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2022 | Mar 18, 2026 | Prot_SAP_000.pdf |
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| No SGLT2i | Other | No SGLT2i |
|
| LVEF (Left Ventricular Ejection Fraction) |
| 6 months after pre-LVAD |
| RV (Normal Right Ventricular) Size | 6 months after pre-LVAD |
| Creatitine | 6 months after pre-LVAD |
| ALT (Alanine Aminotransferase/SGPT) | 6 months after pre-LVAD |
| AST (Aspartate Aminotransferase/SGOT) | 6 month after pre-LVAD |
| Total Bilirubin (Bili) | 6 month after pre-LVAD |
| Alk Phos (Alkaline Phosphatase/ALP) | 6 month after pre-LVAD |
| No SGLT2i |
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. No SGLT2i: No SGLT2i |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Secondary | Weight Change | One patient in SGLT2i arm was lost to follow-up. | Posted | Median | Inter-Quartile Range | Kilograms (Kg) | 6 months after pre-LVAD |
|
|
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| Secondary | Diuretic Dose | Diuretic Dose at 6 months in PO lasix equivalents | One patient in SGLT2i arm was lost to follow-up. | Posted | Median | Inter-Quartile Range | milligrams (mg) | 6 months after pre-LVAD |
|
|
|
| Secondary | LVEF (Left Ventricular Ejection Fraction) | One patient in SGLT2i arm was lost to follow-up. | Posted | Median | Inter-Quartile Range | percentage of ejection fraction | 6 months after pre-LVAD |
|
|
|
| Secondary | RV (Normal Right Ventricular) Size | One patient in SGLT2i arm was lost to follow-up. | Posted | Median | Inter-Quartile Range | centimeters (cm) | 6 months after pre-LVAD |
|
|
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| Secondary | Creatitine | One patient in SGLT2i arm was lost to follow-up. | Posted | Median | Inter-Quartile Range | Milligrams per Deciliter (mg/dL) | 6 months after pre-LVAD |
|
|
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| Secondary | ALT (Alanine Aminotransferase/SGPT) | One patient in SGLT2i arm was lost to follow-up. | Posted | Median | Inter-Quartile Range | Units/Liter | 6 months after pre-LVAD |
|
|
|
| Secondary | AST (Aspartate Aminotransferase/SGOT) | One patient in SGLT2i arm was lost to follow-up. | Posted | Median | Inter-Quartile Range | Units/Liter | 6 month after pre-LVAD |
|
|
|
| Secondary | Total Bilirubin (Bili) | One patient in SGLT2i was lost to follow-up. | Posted | Median | Inter-Quartile Range | Milligrams per Deciliter (mg/dL) | 6 month after pre-LVAD |
|
|
|
| Secondary | Alk Phos (Alkaline Phosphatase/ALP) | One patient in SGLT2i arm was lost to follow-up. | Posted | Median | Inter-Quartile Range | Units/Liter | 6 month after pre-LVAD |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 8 |
| 18 |
| EG001 | No SGLT2i | 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. No SGLT2i: No SGLT2i | 0 | 13 | 0 | 13 | 6 | 13 |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Device related infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
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| Bacteremia | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Wound infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Gallbladder infection | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
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