Trial Outcomes & Findings for HF Patients With LVADs Being Treated With SGLT2i (NCT NCT05278962)
NCT ID: NCT05278962
Last Updated: 2026-05-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
6 months after pre-LVAD
Results posted on
2026-05-08
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
13
|
|
Overall Study
COMPLETED
|
17
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Discontinued intervention
|
1
|
1
|
Baseline Characteristics
HF Patients With LVADs Being Treated With SGLT2i
Baseline characteristics by cohort
| Measure |
SGLT2i
n=19 Participants
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
|
No SGLT2i
n=13 Participants
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
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
n=41 Participants
|
57 years
n=40 Participants
|
52 years
n=81 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=41 Participants
|
4 Participants
n=40 Participants
|
10 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=41 Participants
|
9 Participants
n=40 Participants
|
22 Participants
n=81 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
11 Participants
n=41 Participants
|
8 Participants
n=40 Participants
|
19 Participants
n=81 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=41 Participants
|
5 Participants
n=40 Participants
|
13 Participants
n=81 Participants
|
PRIMARY outcome
Timeframe: 6 months after pre-LVADPopulation: One patient in SGLT2i arm was lost to follow up.
Outcome measures
| Measure |
SGLT2i
n=18 Participants
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
|
No SGLT2i
n=13 Participants
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
|
|---|---|---|
|
Change in Left Ventricular End-diastolic Dimension (LVEDD)
|
-1.1 centimeters (cm)
Interval -2.4 to -0.4
|
-0.9 centimeters (cm)
Interval -1.3 to -0.5
|
SECONDARY outcome
Timeframe: 6 months after pre-LVADPopulation: One patient in SGLT2i arm was lost to follow-up.
Outcome measures
| Measure |
SGLT2i
n=18 Participants
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
|
No SGLT2i
n=13 Participants
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
|
|---|---|---|
|
Weight Change
|
-1.2 Kilograms (Kg)
Interval -5.25 to 1.04
|
0.7 Kilograms (Kg)
Interval -1.5 to 7.6
|
SECONDARY outcome
Timeframe: 6 months after pre-LVADPopulation: One patient in SGLT2i arm was lost to follow-up.
Diuretic Dose at 6 months in PO lasix equivalents
Outcome measures
| Measure |
SGLT2i
n=18 Participants
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
|
No SGLT2i
n=13 Participants
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
|
|---|---|---|
|
Diuretic Dose
|
80 milligrams (mg)
Interval 30.0 to 160.0
|
80 milligrams (mg)
Interval 0.0 to 120.0
|
SECONDARY outcome
Timeframe: 6 months after pre-LVADPopulation: One patient in SGLT2i arm was lost to follow-up.
Outcome measures
| Measure |
SGLT2i
n=18 Participants
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
|
No SGLT2i
n=13 Participants
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
|
|---|---|---|
|
LVEF (Left Ventricular Ejection Fraction)
|
17.5 percentage of oxygen-rich blood pumped o
Interval 15.0 to 20.0
|
18.55 percentage of oxygen-rich blood pumped o
Interval 16.25 to 20.5
|
SECONDARY outcome
Timeframe: 6 months after pre-LVADPopulation: One patient in SGLT2i arm was lost to follow-up.
Outcome measures
| Measure |
SGLT2i
n=18 Participants
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
|
No SGLT2i
n=13 Participants
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
|
|---|---|---|
|
RV (Normal Right Ventricular) Size
|
4.5 centimeters (cm)
Interval 4.025 to 5.0
|
3.8 centimeters (cm)
Interval 3.55 to 4.15
|
SECONDARY outcome
Timeframe: 6 months after pre-LVADPopulation: One patient in SGLT2i arm was lost to follow-up.
Outcome measures
| Measure |
SGLT2i
n=18 Participants
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
|
No SGLT2i
n=13 Participants
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
|
|---|---|---|
|
Creatitine
|
1.03 Milligrams per Deciliter (mg/dL)
Interval 0.89 to 1.5275
|
1.17 Milligrams per Deciliter (mg/dL)
Interval 1.0 to 1.3075
|
SECONDARY outcome
Timeframe: 6 months after pre-LVADPopulation: One patient in SGLT2i arm was lost to follow-up.
Outcome measures
| Measure |
SGLT2i
n=18 Participants
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
|
No SGLT2i
n=13 Participants
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
|
|---|---|---|
|
ALT (Alanine Aminotransferase/SGPT)
|
31 Units/Liter
Interval 19.0 to 38.0
|
14.5 Units/Liter
Interval 11.0 to 21.5
|
SECONDARY outcome
Timeframe: 6 month after pre-LVADPopulation: One patient in SGLT2i arm was lost to follow-up.
Outcome measures
| Measure |
SGLT2i
n=18 Participants
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
|
No SGLT2i
n=13 Participants
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
|
|---|---|---|
|
AST (Aspartate Aminotransferase/SGOT)
|
30 Units/Liter
Interval 24.0 to 42.0
|
22.5 Units/Liter
Interval 18.25 to 24.75
|
SECONDARY outcome
Timeframe: 6 month after pre-LVADPopulation: One patient in SGLT2i was lost to follow-up.
Outcome measures
| Measure |
SGLT2i
n=18 Participants
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
|
No SGLT2i
n=13 Participants
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
|
|---|---|---|
|
Total Bilirubin (Bili)
|
0.7 Milligrams per Deciliter (mg/dL)
Interval 0.5 to 0.9
|
0.55 Milligrams per Deciliter (mg/dL)
Interval 0.5 to 0.78
|
SECONDARY outcome
Timeframe: 6 month after pre-LVADPopulation: One patient in SGLT2i arm was lost to follow-up.
Outcome measures
| Measure |
SGLT2i
n=18 Participants
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
|
No SGLT2i
n=13 Participants
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
|
|---|---|---|
|
Alk Phos (Alkaline Phosphatase/ALP)
|
124 Units/Liter
Interval 83.0 to 152.0
|
88.5 Units/Liter
Interval 73.0 to 131.25
|
Adverse Events
SGLT2i
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
No SGLT2i
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SGLT2i
n=18 participants at risk
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
|
No SGLT2i
n=13 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/18 • 6 months
|
7.7%
1/13 • 6 months
|
|
Gastrointestinal disorders
Gallbladder infection
|
0.00%
0/18 • 6 months
|
7.7%
1/13 • 6 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/18 • 6 months
|
7.7%
1/13 • 6 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
11.1%
2/18 • 6 months
|
7.7%
1/13 • 6 months
|
|
Infections and infestations
Bacteremia
|
5.6%
1/18 • 6 months
|
0.00%
0/13 • 6 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/18 • 6 months
|
7.7%
1/13 • 6 months
|
|
Infections and infestations
abdominal infection
|
5.6%
1/18 • 6 months
|
0.00%
0/13 • 6 months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
5.6%
1/18 • 6 months
|
7.7%
1/13 • 6 months
|
|
Infections and infestations
Device related infection
|
22.2%
4/18 • 6 months
|
0.00%
0/13 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place