CompletedNCT03030222EMBRACE-HFUpdated Dec 9, 2021Results posted

Empagliflozin Impact on Hemodynamics in Patients With Heart Failure

A Phase 4 interventional study of Empagliflozin 10 mg Tab and Placebo Oral Tablet in Heart Failure, sponsored by Saint Luke's Health System. Completed at 10 sites in United States. Open to participants aged 19 Years to 119 Years. Per ClinicalTrials.gov, last updated 2021-12-09.

Sponsored by Saint Luke's Health System · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 65
Allocation: Randomized
Ages: 19 Years to 119 Years
Sex: All

Study summary

The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, on hemodynamic parameters (pulmonary artery diastolic pressure) in patients with heart failure (reduced or preserved ejection fraction, ischemic or non-ischemic etiology) who already have a CardioMEMs device (a wireless hemodynamic monitoring system) implanted for non-study related clinical reasons.

Read the detailed description

A 12-week randomized, double-blind, placebo-controlled trial to explore the effects of once-daily empagliflozin 10 mg on hemodynamic parameters (pulmonary artery pressures) in patients with heart failure (reduced or preserved ejection fraction, ischemic or non-ischemic etiology) who already have a CardioMEMs device implanted for non-study related clinical reasons.

Conditions studied

Heart Failure

Browse trials for

Heart Failure 5,701

Keywords

heart failure
empagliflozin
Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 65 is close to the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Saint Luke's Health System is the lead sponsor of 35 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 119 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Established diagnosis of heart failure (for at least 16 weeks prior to the screening visit) with either preserved (LVEF>40%) or reduced systolic function (LVEF≤40%), due to either ischemic or non-ischemic etiology, documented by an imaging modality (echocardiography, nuclear imaging, LV angiography, magnetic resonance imaging) within the past 24 months.
No major change in diuretic management for 48 hours prior to screening visit or 48 hours prior to randomization visit (major change defined by doubling of diuretic dose or addition of another diuretic medication)
New York Heart Association (NYHA) class II, III or IV heart failure symptoms at the screening and randomization visit
Presence of previously (≥ 2 weeks prior to screening visit) implanted CardioMEMs pulmonary artery pressure monitor for a clinical indication unrelated to the study.
Pulmonary artery diastolic pressure ≥ 12 mmHg at the time of the screening visit (last measurement available prior to the screening visit).
Ability to provide informed consent prior to initiating screening visit procedures

Exclusion criteria

Exclusion Criteria:

Decompensated heart failure (hospitalization for heart failure within the 2 weeks prior to screening) or between screening and randomization
History of type 1 diabetes
Major change in diuretic management during 48 hours prior to screening visit or 48 hours prior to randomization visit. (major change defined by doubling of diuretic dose or addition of another diuretic medications)
Significant variability in baseline pulmonary artery diastolic pressures during screening period. Defined as changes greater than +/- 6 mmHg from average pulmonary artery diastolic pressure during week 1 of the screening phase and average pulmonary artery diastolic pressure during week 2 of the screening phase for those patients with an average baseline pulmonary artery diastolic pressure during week 1 of the screening phase of \<30 mmHg. If the average baseline pulmonary artery diastolic pressure during week 1 of the screening phase is ≥30 mmHg, then ≥20% relative change in average pulmonary diastolic pressure between week 1 and week 2 of the screening phase will be used to define significant variability.
Initiation of hydralazine, long-acting nitrates, beta blockers, angiotensin-converting enzyme inhibitors (ACEIs) , angiotensin II receptor blockers (ARBs) or valsartan/sacubitril in the prior 4 weeks prior to screening
Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 at the screening visit
Admission for an acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within 30 days prior to the screening visit.
Implantation of cardiac resynchronization therapy (CRT) device within the previous 90 days.
Implantation of the CardioMEMs device within the past 2 weeks.
Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy), or planned implantation of cardiac resynchronization therapy (CRT) device within the 90 days after the screening visit.
Participation in any interventional clinical trial (with an investigational drug or device) that is not an observational registry within the 4 weeks prior to the screening visit.
History of hypersensitivity to empagliflozin
For women of child-bearing potential: Current or planned pregnancy or currently lactating
Life expectancy \<1 year at the screening visit
Patients who are volume depleted based upon physical examination at the time of the screening or randomization visit
Pulmonary artery diastolic pressure \< 12 mmHg at the time of the screening visit (average of last four measurements available prior to the screening visit).
Patients currently being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) or having received treatment with any SGLT-2 inhibitor within the 8 weeks prior to the screening visit
Average supine systolic BP \<90 mmHg at the screening or randomization visit
Current documented history of bladder cancer
Active Gross Hematuria
Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valve disease, and hypertrophic obstructive cardiomyopathy (HOCM).
History of heart transplant.
Patients on heart transplant list as 1a and 1b status

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 65 participants (actual)

Study arms

Active comparator
Empagliflozin
Empagliflozin 10 mg tab, once daily, for 12 weeks
Drug: Empagliflozin 10 mg Tab
Placebo comparator
Placebo
Empagliflozin matching placebo oral tablet, once daily for 12 weeks
Drug: Placebo Oral Tablet

Interventions

DrugEmpagliflozin 10 mg Tab
Empagliflozin 10 mg Tab
Also known as: Jardiance
DrugPlacebo Oral Tablet
Empagliflozin matching placebo
Also known as: Placebo

What researchers measure

Primary outcomes

Change in Pulmonary Artery Diastolic Pressure From Baseline to End of Treatment Period (Defined as Average of Pulmonary Artery Diastolic Pressure Measurements Between Weeks 8-12) Between Empagliflozin and Placebo
Change in pulmonary artery diastolic pressure from baseline to end of treatment period (defined as average of pulmonary artery diastolic pressure measurements between weeks 8-12) between empagliflozin and placebo
Time frame: Baseline to average between Weeks 8-12

Secondary outcomes

Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo.
Change from baseline in pulmonary artery diastolic pressure at each interim timepoint (wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) between empagliflozin and placebo.
Time frame: Baseline to Weeks 1-12
Change in Pulmonary Artery Systolic Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo.
Change in pulmonary artery systolic pressure from baseline to end of treatment period (week 12) between empagliflozin and placebo.
Time frame: Baseline to Week 12
Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo.
Change from baseline in pulmonary artery systolic pressure at each interim time point (wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) between empagliflozin and placebo.
Time frame: Baseline to Weeks 1-12
Change in Mean Pulmonary Artery Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo.
Change in mean pulmonary artery pressure from baseline to end of treatment period (week 12) between empagliflozin and placebo.
Time frame: Baseline to Week 12
Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo.
Change from baseline in mean pulmonary artery pressure at each interim time point (weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) between empagliflozin and placebo.
Time frame: Baseline to Weeks 1-12
Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.
Time frame: Baseline to Week 6 and Week 12
Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.
Time frame: Baseline to Week 6 and Week 12
Change in 6 Minute Walk Test From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
Change in 6 minute walk test from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo.
Time frame: Baseline to Week 6 and Week 12
Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo.
Time frame: Baseline to Week 6 and Week 12
Change in Brain Natriuretic Peptide (BNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
Change in brain natriuretic peptide (BNP) from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo.
Time frame: Baseline to Week 6 and Week 12
Proportion of Patients With a ≥ 20% Decrease From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.
Proportion of patients with a ≥ 20% decrease from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo.
Time frame: Baseline to Week 6 and Week 12
Proportion of Patients With a ≥ 20% Decrease From Baseline in Brain Natriuretic Peptide (BNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.
Proportion of patients with a ≥ 20% decrease from baseline in brain natriuretic peptide (BNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo.
Time frame: Baseline to Week 6 and Week 12
Proportion of Patients With Both a ≥ 5 Point Increase From Baseline in KCCQ-OS and a ≥ 20% Decrease From Baseline in NT-proBNP at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.
Proportion of patients with both a ≥ 5 point increase from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) and a ≥ 20% decrease from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.
Time frame: Baseline to Week 6 and Week 12
Number of Participants With Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo
Number of Participants with Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo
Time frame: Baseline to Week 12
Change in Hemoglobin A1c From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
Change in Hemoglobin A1c from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo.
Time frame: Baseline to Week 6 and Week 12

Results

Posted Dec 9, 2021

Participant flow

Participant flow — Overall Study
Milestone	Empagliflozin	Placebo
Started	33	32
Completed	33	32
Not completed	0	0

Outcome measures

PrimaryChange in Pulmonary Artery Diastolic Pressure From Baseline to End of Treatment Period (Defined as Average of Pulmonary Artery Diastolic Pressure Measurements Between Weeks 8-12) Between Empagliflozin and Placebo

Change in pulmonary artery diastolic pressure from baseline to end of treatment period (defined as average of pulmonary artery diastolic pressure measurements between weeks 8-12) between empagliflozin and placebo

Time frame:: Baseline to average between Weeks 8-12
Reported as:: Mean · mm Hg

Change in Pulmonary Artery Diastolic Pressure From Baseline to End of Treatment Period (Defined as Average of Pulmonary Artery Diastolic Pressure Measurements Between Weeks 8-12) Between Empagliflozin and Placebo
mm Hg	Empagliflozin	Placebo
Change in Pulmonary Artery Diastolic Pressure From Baseline to End of Treatment Period (Defined as Average of Pulmonary Artery Diastolic Pressure Measurements Between Weeks 8-12) Between Empagliflozin and Placebo	20.7 (19.6 to 21.7)	22.2 (21.1 to 23.2)

SecondaryChange From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo.

Change from baseline in pulmonary artery diastolic pressure at each interim timepoint (wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) between empagliflozin and placebo.

Time frame:: Baseline to Weeks 1-12
Reported as:: Mean · mm Hg

Change From Baseline in Pulmonary Artery Diastolic Pressure at Each Interim Timepoint (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12) Between Empagliflozin and Placebo.
mm Hg	Empagliflozin	Placebo
Pulmonary artery diastolic pressure - Week 0	21.2 (20.4 to 22.1)	21.4 (20.5 to 22.2)
Pulmonary artery diastolic pressure - Week 1	21.2 (20.4 to 21.9)	21.5 (20.7 to 22.3)
Pulmonary artery diastolic pressure - Week 2	21.1 (20.3 to 21.9)	21.7 (20.9 to 22.4)
Pulmonary artery diastolic pressure - Week 3	21.1 (20.2 to 21.9)	21.8 (20.9 to 22.6)
Pulmonary artery diastolic pressure - Week 4	21.0 (20.1 to 22.0)	21.9 (21.0 to 22.8)
Pulmonary artery diastolic pressure - Week 5	21.0 (20.1 to 22.0)	22.0 (21.0 to 23.0)
Pulmonary artery diastolic pressure - Week 6	21.0 (20.0 to 22)	22.1 (21.1 to 23.1)
Pulmonary artery diastolic pressure - Week 7	21.0 (19.9 to 22.0)	22.1 (21.1 to 23.2)
Pulmonary artery diastolic pressure - Week 8	21.0 (19.8 to 22.0)	22.2 (21.1 to 23.2)
Pulmonary artery diastolic pressure - Week 9	20.8 (19.7 to 21.9)	22.2 (21.1 to 23.3)
Pulmonary artery diastolic pressure - Week 10	20.7 (19.6 to 21.8)	22.2 (21.1 to 23.3)
Pulmonary artery diastolic pressure - Week 11	20.5 (19.5 to 21.6)	22.2 (21.0 to 23.3)
Pulmonary artery diastolic pressure - Week 12	20.4 (19.2 to 21.6)	22.1 (20.9 to 23.3)

SecondaryChange in Pulmonary Artery Systolic Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo.

Change in pulmonary artery systolic pressure from baseline to end of treatment period (week 12) between empagliflozin and placebo.

Time frame:: Baseline to Week 12
Reported as:: Mean · mm Hg

Change in Pulmonary Artery Systolic Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo.
mm Hg	Empagliflozin	Placebo
Change in Pulmonary Artery Systolic Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo.	20.4 (19.2 to 21.6)	22.1 (20.9 to 23.3)

SecondaryChange From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo.

Change from baseline in pulmonary artery systolic pressure at each interim time point (wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) between empagliflozin and placebo.

Time frame:: Baseline to Weeks 1-12
Reported as:: Mean · mm Hg

Change From Baseline in Pulmonary Artery Systolic Pressure at Each Interim Time Point (Wks 1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12) Between Empagliflozin and Placebo.
mm Hg	Empagliflozin	Placebo
Pulmonary artery systolic pressure - Week 0	44.1 (42.6 to 45.6)	43.9 (42.4 to 45.3)
Pulmonary artery systolic pressure - Week 1	44.1 (42.8 to 45.4)	44.0 (42.7 to 45.2)
Pulmonary artery systolic pressure - Week 2	44.1 (42.8 to 45.4)	44.1 (42.8 to 45.3)
Pulmonary artery systolic pressure - Week 3	44.1 (42.6 to 45.5)	44.2 (42.7 to 45.6)
Pulmonary artery systolic pressure - Week 4	44.0 (42.5 to 45.6)	44.3 (42.7 to 45.8)
Pulmonary artery systolic pressure - Week 5	44.0 (42.3 to 45.6)	44.4 (42.8 to 46.0)
Pulmonary artery systolic pressure - Week 6	44.0 (42.2 to 45.6)	44.6 (42.9 to 46.3)
Pulmonary artery systolic pressure - Week 7	43.8 (42.0 to 45.6)	44.7 (42.9 to 46.5)
Pulmonary artery systolic pressure - Week 8	43.7 (41.8 to 45.6)	44.8 (42.9 to 46.8)
Pulmonary artery systolic pressure - Week 9	43.6 (41.6 to 45.5)	44.9 (42.9 to 46.9)
Pulmonary artery systolic pressure - Week 10	43.4 (41.5 to 45.3)	44.9 (43.0 to 46.9)
Pulmonary artery systolic pressure - Week 11	43.3 (41.3 to 45.2)	44.9 (43.0 to 46.9)
Pulmonary artery systolic pressure - Week 12	43.1 (41.0 to 45.1)	44.9 (42.8 to 46.9)

SecondaryChange in Mean Pulmonary Artery Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo.

Change in mean pulmonary artery pressure from baseline to end of treatment period (week 12) between empagliflozin and placebo.

Time frame:: Baseline to Week 12
Reported as:: Mean · mm Hg

Change in Mean Pulmonary Artery Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo.
mm Hg	Empagliflozin	Placebo
Change in Mean Pulmonary Artery Pressure From Baseline to End of Treatment Period (Week 12) Between Empagliflozin and Placebo.	29.3 (27.9 to 30.8)	31.1 (29.6 to 32.5)

SecondaryChange From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo.

Change from baseline in mean pulmonary artery pressure at each interim time point (weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) between empagliflozin and placebo.

Time frame:: Baseline to Weeks 1-12
Reported as:: Mean · mm Hg

Change From Baseline in Mean Pulmonary Artery Pressure at Each Interim Time Point (Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) Between Empagliflozin and Placebo.
mm Hg	Empagliflozin	Placebo
Pulmonary artery pressure - Week 0	30.1 (29.0 to 31.2)	30.1 (29.0 to 31.2)
Pulmonary artery pressure - Week 1	30.1 (29.1 to 31.1)	30.2 (29.2 to 31.2)
Pulmonary artery pressure - Week 2	30.1 (29.1 to 31.0)	30.4 (29.4 to 31.4)
Pulmonary artery pressure - Week 3	30.0 (29.0 to 31.1)	30.5 (29.5 to 31.6)
Pulmonary artery pressure - Week 4	30.0 (28.9 to 31.2)	30.7 (29.5 to 31.8)
Pulmonary artery pressure - Week 5	30.0 (28.8 to 31.2)	30.8 (29.6 to 32.0)
Pulmonary artery pressure - Week 6	30.0 (28.7 to 31.2)	30.9 (29.7 to 32.2)
Pulmonary artery pressure - Week 7	29.9 (28.6 to 31.2)	31.0 (29.7 to 32.3)
Pulmonary artery pressure - Week 8	29.9 (28.5 to 31.2)	31.1 (29.7 to 32.4)
Pulmonary artery pressure - Week 9	29.8 (28.4 to 31.1)	31.1 (29.7 to 32.5)
Pulmonary artery pressure - Week 10	29.6 (28.2 to 31)	31.1 (29.8 to 32.5)
Pulmonary artery pressure - Week 11	29.5 (28.1 to 30.8)	31.1 (29.7 to 32.5)
Pulmonary artery pressure - Week 12	29.3 (27.9 to 30.8)	31.1 (29.6 to 32.5)

SecondaryChange in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.

Time frame:: Baseline to Week 6 and Week 12
Reported as:: Mean · score on a scale

Change in Heart Failure Related Quality of Life, Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) From Baseline to Follow-up (Defines as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
score on a scale	Empagliflozin	Placebo
Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) score - 6 weeks	63.5 (58.0 to 68.9)	66.6 (61.0 to 72.2)
Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) score - 12 weeks	64.2 (58.8 to 69.6)	61.7 (56.2 to 67.3)
Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) score - 6 weeks	66.6 (61.1 to 72.2)	65.6 (60.0 to 71.3)
Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) score - 12 weeks	65.8 (60.3 to 71.2)	60.2 (54.5 to 65.9)

SecondaryProportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.

Time frame:: Baseline to Week 6 and Week 12
Reported as:: Count of participants · Participants

Proportion of Patients With a ≥ 5 Point Increase From Baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.
Participants	Empagliflozin	Placebo
KCCQ-OS score increase >/= 5 points (6 weeks)	13	15
KCCQ-OS score increase >/= 5 points (12 weeks)	11	10
KCCQ-CS score increase >/= 5 points (6 weeks)	13	10
KCCQ-CS score increase >/= 5 points (12 weeks)	12	5

SecondaryChange in 6 Minute Walk Test From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.

Change in 6 minute walk test from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo.

Time frame:: Baseline to Week 6 and Week 12
Reported as:: Mean · meters

Change in 6 Minute Walk Test From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
meters	Empagliflozin	Placebo
6-minute walk distance - 6 weeks	202.5 (170.9 to 239.8)	211.2 (177.0 to 252.0)
6-minute walk distance - 12 weeks	217.4 (183.3 to 257.9)	174.7 (146.6 to 208.0)

SecondaryChange in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.

Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo.

Time frame:: Baseline to Week 6 and Week 12
Reported as:: Mean · pg/mL

Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
pg/mL	Empagliflozin	Placebo
NT-proBNP - 6 weeks	693 (556 to 865)	655 (518 to 830)
NT-proBNP - 12 weeks	659 (528 to 822)	802 (635 to 1013)

SecondaryChange in Brain Natriuretic Peptide (BNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.

Change in brain natriuretic peptide (BNP) from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo.

Time frame:: Baseline to Week 6 and Week 12
Reported as:: Mean · pg/mL

Change in Brain Natriuretic Peptide (BNP) From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
pg/mL	Empagliflozin	Placebo
BNP - 6 weeks	143 (113 to 180)	149 (116 to 191)
BNP - 12 weeks	144 (114 to 182)	167 (130 to 214)

SecondaryProportion of Patients With a ≥ 20% Decrease From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.

Proportion of patients with a ≥ 20% decrease from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo.

Time frame:: Baseline to Week 6 and Week 12
Reported as:: Count of participants · Participants

Proportion of Patients With a ≥ 20% Decrease From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.
Participants	Empagliflozin	Placebo
NT-proBNP decrease >/= 20% - 6 weeks	10	6
NT-proBNP decrease >/= 20% - 12 weeks	11	2

SecondaryProportion of Patients With a ≥ 20% Decrease From Baseline in Brain Natriuretic Peptide (BNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.

Proportion of patients with a ≥ 20% decrease from baseline in brain natriuretic peptide (BNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo.

Time frame:: Baseline to Week 6 and Week 12
Reported as:: Count of participants · Participants

Proportion of Patients With a ≥ 20% Decrease From Baseline in Brain Natriuretic Peptide (BNP) at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.
Participants	Empagliflozin	Placebo
BNP decrease >/= 20% - 6 weeks	12	6
BNP decrease >/= 20% - 12 weeks	11	4

SecondaryProportion of Patients With Both a ≥ 5 Point Increase From Baseline in KCCQ-OS and a ≥ 20% Decrease From Baseline in NT-proBNP at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.

Proportion of patients with both a ≥ 5 point increase from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) and a ≥ 20% decrease from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at either 6 weeks or 12 weeks of follow-up between empagliflozin and placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the Kansas City Cardiomyopathy Questionnaire Overall Summary Score KCCQ-OS, a small but clinically meaningful change is considered to be ≥ 5 points.

Time frame:: Baseline to Week 6 and Week 12
Reported as:: Count of participants · Participants

Proportion of Patients With Both a ≥ 5 Point Increase From Baseline in KCCQ-OS and a ≥ 20% Decrease From Baseline in NT-proBNP at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.
Participants	Empagliflozin	Placebo
Proportion of Patients With Both a ≥ 5 Point Increase From Baseline in KCCQ-OS and a ≥ 20% Decrease From Baseline in NT-proBNP at Either 6 Weeks or 12 Weeks of Follow-up Between Empagliflozin and Placebo.	19	14

SecondaryNumber of Participants With Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo

Number of Participants with Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo

Time frame:: Baseline to Week 12
Reported as:: Count of participants · Participants

Number of Participants With Diuretic Medication Adjustments During the Treatment Period Between Empagliflozin and Placebo
Participants	Empagliflozin	Placebo
Number of patients with no loop diuretic changes	25	26
Number of patients with loop diuretic changes	8	6

SecondaryChange in Hemoglobin A1c From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.

Change in Hemoglobin A1c from baseline to follow-up (defined as average of measurements at 6 and 12 weeks) between empagliflozin and placebo.

Time frame:: Baseline to Week 6 and Week 12
Reported as:: Mean · percentage of hemoglobin

Change in Hemoglobin A1c From Baseline to Follow-up (Defined as Average of Measurements at 6 and 12 Weeks) Between Empagliflozin and Placebo.
percentage of hemoglobin	Empagliflozin	Placebo
Hemoglobin A1c - 6 weeks	6.6 (6.3 to 6.9)	6.5 (6.2 to 6.8)
Hemoglobin A1c - 12 weeks	6.8 (6.5 to 7.1)	6.3 (6.1 to 6.6)

Adverse events

Collected over Adverse events were collected for up to 15 weeks. The adverse event collection period started at the time the patient signed consent at their Screening Visit, continued through a 12-week double-blind treatment period after randomization, and ended after completion of a 1-week follow-up period after completion of the double-blind treatment period.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Empagliflozin	1/33 (3%)	8/33 (24.2%)	19/33 (57.6%)
Placebo	0/32 (0%)	9/32 (28.1%)	16/32 (50%)

Most frequent serious events

Showing 10 of 18

Most frequent serious events
Event	Empagliflozin	Placebo
Exacerbation of Heart FailureCardiac disorders	4/33	4/32
Volume DepletionGeneral disorders	1/33	1/32
EndocarditisCardiac disorders	0/33	1/32
Ventricular TachycardiaCardiac disorders	0/33	1/32
PneumoniaInfections and infestations	0/33	1/32
CardioMEMS device recalibrationGeneral disorders	0/33	1/32
Myocardial InfarctionCardiac disorders	1/33	1/32
Chest PainCardiac disorders	1/33	0/32
BronchitisInfections and infestations	1/33	0/32
CellulitisInfections and infestations	1/33	0/32

Most frequent other events

Showing 10 of 55

Most frequent other events
Event	Empagliflozin	Placebo
Exacerbation of Heart FailureCardiac disorders	3/33	3/32
HypokalemiaGeneral disorders	3/33	0/32
Volume DepletionGeneral disorders	3/33	1/32
Acute Kidney InjuryGeneral disorders	1/33	2/32
Gout FlareGeneral disorders	1/33	2/32
Chest PainCardiac disorders	2/33	1/32
CoughGeneral disorders	2/33	0/32
Asymptomatic hypoglycemiaEndocrine disorders	1/33	1/32
Bilateral HandshakingGeneral disorders	0/33	1/32
BloatingGeneral disorders	0/33	1/32

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Empagliflozin	Placebo	Total
Mean	69.5 ± 12.0	62.9 ± 13.3	66.2 ± 12.9

Sex: Female, Male
Sex: Female, Male(Participants)	Empagliflozin	Placebo	Total
Female	12	12	24
Male	21	20	41

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Empagliflozin	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	5	7	12
White	27	23	50
More than one race	0	0	0
Unknown or Not Reported	1	2	3

Region of Enrollment
Region of Enrollment(participants)	Empagliflozin	Placebo	Total
United States	33	32	65

Duration of Heart Failure
Duration of Heart Failure(years)	Empagliflozin	Placebo	Total
Mean	5.4 ± 5.7	7.2 ± 5.5	6.3 ± 5.6

Prior hospitalization for heart failure
Prior hospitalization for heart failure(Participants)	Empagliflozin	Placebo	Total
Count of participants	29	28	57

Time since last hospitalization for heart failure
Time since last hospitalization for heart failure(years)	Empagliflozin	Placebo	Total
Mean	1.3 ± 0.9	1.5 ± 1.4	1.4 ± 1.2

Ejection fraction
Ejection fraction(%)	Empagliflozin	Placebo	Total
Mean	46.7 ± 14.9	40.7 ± 17.2	43.7 ± 16.2

34 further baseline measures are reported on the registry.

Study locations

10 sites

University of Southern California
Los Angeles, California 90033, United States
First Coast Cardiovascular Institute
Jacksonville, Florida 32256, United States
NorthShore University Health System Research Institute
Evanston, Illinois 60201, United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota 56303, United States
St. Francis Hospital
Roslyn, New York 11576, United States
Ohio State University
Columbus, Ohio 43210, United States
Sanford Research
Sioux Falls, South Dakota 57104, United States
Austin Heart Clinical Research
Austin, Texas 78756, United States
Baylor College of Medicine
Houston, Texas 77030, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia 23507, United States

References and documents

Publications

Nassif ME, Qintar M, Windsor SL, Jermyn R, Shavelle DM, Tang F, Lamba S, Bhatt K, Brush J, Civitello A, Gordon R, Jonsson O, Lampert B, Pelzel J, Kosiborod MN. Empagliflozin Effects on Pulmonary Artery Pressure in Patients With Heart Failure: Results From the EMBRACE-HF Trial. Circulation. 2021 Apr 27;143(17):1673-1686. doi: 10.1161/CIRCULATIONAHA.120.052503. Epub 2021 Feb 8. PubMed 33550815 ↗
Nassif ME, Spertus JA, Tang F, Windsor SL, Jones P, Thomas M, Khariton Y, Brush J, Gordon RA, Jermyn R, Jonsson O, Lamba S, Shavelle DM, Kosiborod MN. Association Between Change in Ambulatory Hemodynamic Pressures and Symptoms of Heart Failure. Circ Heart Fail. 2021 Nov;14(11):e008446. doi: 10.1161/CIRCHEARTFAILURE.121.008446. Epub 2021 Oct 26. No abstract available. PubMed 34696602 ↗
Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678. PubMed 31081589 ↗

Study documents

Study protocol · Sep 24, 2018
Statistical analysis plan · Mar 8, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03030222
Lead sponsor: Saint Luke's Health System
Responsible party: Sponsor
First posted: Jan 24, 2017
Start date: Jul 5, 2017
Primary completion: Mar 10, 2020
Completion: Mar 10, 2020
Results posted: Dec 9, 2021
Last update: Dec 9, 2021

Study contacts

Mikhail Kosiborod, MD

study chair · Saint Luke's Mid America Heart Institute

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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