Trial Outcomes & Findings for This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms. (NCT NCT03448406)
NCT ID: NCT03448406
Last Updated: 2020-12-08
Results Overview
Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions (6MWTD). If repeated 6-minutes walk test (6MWT) measurements were available for the same day, the longest distance was used for analysis. Change from baseline was defined as the distance walked in 6 minutes at Week 12 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. If a participant was present at the visit at Week 12 but did not perform the 6MWT, the participant was evaluated as having walked a distance of 0 meter. If no value was available for Week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
315 participants
Primary outcome timeframe
At baseline and at Week 12
Results posted on
2020-12-08
Participant Flow
Randomised, double-blind, placebo-controlled, parallel-group trial in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF) to evaluate the effect of Empagliflozin versus Placebo on exercise and heart failure symptoms.
Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct.
Participant milestones
| Measure |
Placebo
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
|---|---|---|
|
Overall Study
STARTED
|
158
|
157
|
|
Overall Study
COMPLETED
|
147
|
144
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
Placebo
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
|---|---|---|
|
Overall Study
Noncompliance of scheduled visits
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
8
|
9
|
Baseline Characteristics
This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms.
Baseline characteristics by cohort
| Measure |
Placebo
n=158 Participants
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
n=157 Participants
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
Total
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.9 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
73.0 Years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
73.5 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance at baseline
|
299.5 Meter
n=5 Participants
|
297.0 Meter
n=7 Participants
|
299.0 Meter
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and at Week 12Population: Randomised Set: All participants that were randomised, regardless of whether treated or not.
Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions (6MWTD). If repeated 6-minutes walk test (6MWT) measurements were available for the same day, the longest distance was used for analysis. Change from baseline was defined as the distance walked in 6 minutes at Week 12 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. If a participant was present at the visit at Week 12 but did not perform the 6MWT, the participant was evaluated as having walked a distance of 0 meter. If no value was available for Week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above.
Outcome measures
| Measure |
Placebo
n=158 Participants
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
n=157 Participants
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
|---|---|---|
|
Change From Baseline to Week 12 in Exercise Capacity as Measured by the Distance Walked in 6 Minutes in Standardised Conditions (6MWTD)
|
5.0 Meter (m)
Interval -20.0 to 33.0
|
10.0 Meter (m)
Interval -10.0 to 32.0
|
SECONDARY outcome
Timeframe: At baseline and at Week 12Population: Randomised Set: All participants that were randomised, regardless of whether treated or not.
Change from baseline in KCCQ-TSS was defined as the endpoint value at week 12 minus the last available measurement before start of treatment with randomised study medication. The KCCQ is 23 item self-administered questionnaire and comprises 7 domains: physical limitation, symptom frequency, symptom burden, symptom stability, social limitation, self-efficacy and quality of life. Additionally 3 summary scores exist: TSS, clinical summary score, and overall summary score. The scores of the KCCQ domains and summary scores range from 0 to 100, with higher score indicating better outcome. If no questionnaire was available at week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above. If no questionnaire was available at baseline, change from baseline was not imputed.
Outcome measures
| Measure |
Placebo
n=158 Participants
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
n=157 Participants
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
|---|---|---|
|
Change From Baseline to Week 12 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS)
|
2.08 Score on a scale
Interval -6.25 to 20.83
|
4.17 Score on a scale
Interval -3.13 to 16.67
|
SECONDARY outcome
Timeframe: At baseline and at Week 12Population: Participants in the randomised set (RS) who have no missing values at baseline.
Change from baseline in CHQ-SAS was defined as the endpoint value at week 12 minus the last available endpoint value before start of treatment with randomised study medication. The CHQ-SAS evaluates 3 domains: dyspnoea, fatigue, and emotional function. Scores of the domains range from 1 to 7, with higher score indicating better quality of life. If no questionnaire was available at week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above. If no questionnaire was available at baseline, change from baseline was not imputed.
Outcome measures
| Measure |
Placebo
n=158 Participants
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
n=156 Participants
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
|---|---|---|
|
Change From Baseline to Week 12 in Chronic Heart Failure Questionnaire Self- Administered Standardized Format (CHQ-SAS) Dyspnea Score
|
0.20 Score on a scale
Interval -0.4 to 1.0
|
0.10 Score on a scale
Interval -0.4 to 1.0
|
SECONDARY outcome
Timeframe: At baseline and at Week 6Population: Randomised Set: All participants that were randomised, regardless of whether treated or not.
Change from baseline to week 6 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. Change from baseline was defined as the distance walked in 6 minutes at Week 6 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. If a participant was present at the visit at Week 6 but did not perform the 6-Minuted Walking Test, the participant was evaluated as having walked a distance of 0 meter. If no value was available for Week 6, an imputed value was used.
Outcome measures
| Measure |
Placebo
n=158 Participants
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
n=157 Participants
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
|---|---|---|
|
Change From Baseline to Week 6 in Exercise Capacity as Measured by the Distance Walked in 6 Minutes
|
1.0 Meter (m)
Interval -17.0 to 21.0
|
7.0 Meter (m)
Interval -14.0 to 23.0
|
SECONDARY outcome
Timeframe: At baseline and at Week 12Population: Only participants in the randomised set (RS) who have values at baseline and at week 12.
Change from baseline to week 12 in Clinical Congestion score is defined as the score-value at week 12 minus the score-value at baseline. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. The Clinical Congestion Score (summary score) is based on 3 items: orthopnoea, jugular venous distention (JVD) and oedema. Each item was assessed through a 4-measure questionnaire, which was further converted to a standardised 4-point scale ranging from 0 to 3, with 0 indicating no or fewer symptoms and 3 indicating continous or more symptoms. If at least 2 of the 3 items are not missing, the summary score is calculated as: (average over items JVD, orthopnea and oedema actually answered)\*3. The summary score ranges from 0 to 9, with lower value indicating better health, and higher value indicating worse health. Mean is adjusted mean.
Outcome measures
| Measure |
Placebo
n=155 Participants
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
n=156 Participants
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
|---|---|---|
|
Change From Baseline in Clinical Congestion Score at Week 12
|
-0.28 Score on scale
Standard Deviation 0.08
|
-0.36 Score on scale
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: At baseline and at Week 12Population: Only participants in the randomised set (RS) who have values at baseline and at week 12.
Change from baseline to week 12 in PGI-S of Heart Failure Symptoms. The Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms is a 1-item questionnaire to assess the patient's impression of symptoms severity, specifically: shortness of breath, fatigue and swelling. The PGI-S asks the Patient to choose one response that best describes how his/her heart failure symptoms, specifically: shortness of breath, fatigue and swelling are now on a 5-category scale, ranging from 'Not at all' (1) to 'Very severe' (5). Number of participants by change in score are reported. Change in score was defined as the number of categories improved/deteriorated from baseline to week 12.
Outcome measures
| Measure |
Placebo
n=154 Participants
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
n=153 Participants
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
|---|---|---|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at Week 12
4 categories improvement
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at Week 12
3 categories improvement
|
2 Participants
|
1 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at Week 12
2 categories improvement
|
11 Participants
|
8 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at Week 12
1 category improvement
|
46 Participants
|
42 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at Week 12
No change
|
70 Participants
|
79 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at Week 12
1 category deterioration
|
17 Participants
|
16 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at Week 12
2 categories deterioration
|
6 Participants
|
6 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at Week 12
3 categories deterioration
|
0 Participants
|
1 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at Week 12
4 categories deterioration
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and at Week 12Population: Only participants in the randomised set (RS) who have values at baseline and at week 12.
Change from baseline to week 12 in Patient Global Impression of Severity (PGI-S) of dyspnoea. The PGI-S of Dyspnoea is a 1-item questionnaire designed to assess the participant´s impression of symptom severity, specifically dyspnoea. The PGI-S item asks the participant to choose one response that best describes how his/her dyspnoea is now on a 5-category scale, ranging from 'Not at all' (1) to 'Very severe' (5). Number of participants by change in score are reported. Change in score was defined as the number of categories improved/deteriorated from baseline to week 12.
Outcome measures
| Measure |
Placebo
n=154 Participants
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
n=153 Participants
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
|---|---|---|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Dyspnea Severity at Week 12
4 categories improvement
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Dyspnea Severity at Week 12
3 categories improvement
|
4 Participants
|
1 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Dyspnea Severity at Week 12
2 categories improvement
|
8 Participants
|
13 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Dyspnea Severity at Week 12
1 category improvement
|
45 Participants
|
48 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Dyspnea Severity at Week 12
No change
|
70 Participants
|
70 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Dyspnea Severity at Week 12
1 category deterioration
|
18 Participants
|
20 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Dyspnea Severity at Week 12
2 categories deterioration
|
7 Participants
|
1 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Dyspnea Severity at Week 12
3 categories deterioration
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Dyspnea Severity at Week 12
4 categories deterioration
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Only participants in the randomised set (RS) who have values at week 12.
The Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms is a 1-item questionnaire to assess the patient's impression of change in heart failure symptoms, specifically: shortness of breath, fatigue, and swelling. The PGI-C asks the patient to choose one Response that best describes the overall change (if any) in his/her heart failure symptoms, specifically: shortness of breath, fatigue, and swelling since he/she started taking the study medication on a 7- category scale ranging from 'Very much better' (+3) to 'Very much worse' (-3).
Outcome measures
| Measure |
Placebo
n=154 Participants
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
n=153 Participants
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
|---|---|---|
|
Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at Week 12
Very much worse
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at Week 12
Much worse
|
0 Participants
|
3 Participants
|
|
Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at Week 12
A little worse
|
11 Participants
|
7 Participants
|
|
Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at Week 12
No change
|
62 Participants
|
55 Participants
|
|
Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at Week 12
A little better
|
41 Participants
|
48 Participants
|
|
Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at Week 12
Much better
|
31 Participants
|
35 Participants
|
|
Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at Week 12
Very much better
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Only participants in the randomised set (RS) who have values at week 12.
The PGI-C in Dyspnoea is a 1-item questionnaire designed to assess the patient's Impression of change in dyspnoea. The PGI-C asks the patient to choose one response that best describes the change (if any) in his/her shortness of breath when performing usual activities since he/she started taking the study medication on a 7-category scale ranging from 'Very much better' (+3) to 'Very much worse' (-3).
Outcome measures
| Measure |
Placebo
n=154 Participants
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
n=153 Participants
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
|---|---|---|
|
Patient Global Impression of Change (PGI-C) in Dyspnea at Week 12
Very much worse
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGI-C) in Dyspnea at Week 12
Much worse
|
2 Participants
|
3 Participants
|
|
Patient Global Impression of Change (PGI-C) in Dyspnea at Week 12
A little worse
|
6 Participants
|
7 Participants
|
|
Patient Global Impression of Change (PGI-C) in Dyspnea at Week 12
No change
|
72 Participants
|
57 Participants
|
|
Patient Global Impression of Change (PGI-C) in Dyspnea at Week 12
A little better
|
32 Participants
|
45 Participants
|
|
Patient Global Impression of Change (PGI-C) in Dyspnea at Week 12
Much better
|
31 Participants
|
36 Participants
|
|
Patient Global Impression of Change (PGI-C) in Dyspnea at Week 12
Very much better
|
11 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Within 3 weeks prior to treatment start and at Week 12.Population: Only participants in the randomised set (RS) who had values at baseline and at week 12.
Relative change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NTproBNP). Relative change from baseline is expressed as ratio of week 12 to baseline. Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication. Mean is adjusted mean.
Outcome measures
| Measure |
Placebo
n=155 Participants
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
n=156 Participants
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
|---|---|---|
|
Relative Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NTproBNP) at Week 12
|
1.04 Ratio
Interval 0.96 to 1.13
|
0.99 Ratio
Interval 0.92 to 1.08
|
Adverse Events
Placebo
Serious events: 29 serious events
Other events: 0 other events
Deaths: 0 deaths
10 mg Empagliflozin
Serious events: 20 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=158 participants at risk
1 film-coated tablet of Placebo matching Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with preserved ejection fraction (LVEF \> 40%).
|
10 mg Empagliflozin
n=157 participants at risk
1 film-coated tablet of 10 milligram (mg) of Empagliflozin was administered orally once daily for 12 weeks in participants with chronic Heart Failure (CHF) with with preserved ejection fraction (LVEF \> 40%).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
2/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
1.3%
2/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
8.2%
13/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
3.8%
6/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Cardiac disorders
Pericarditis
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
General disorders
Generalised oedema
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Infections and infestations
Arthritis bacterial
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Infections and infestations
Helicobacter duodenitis
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Infections and infestations
Necrotising fasciitis
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Investigations
Blood glucose increased
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Nervous system disorders
Seizure
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Renal and urinary disorders
Anuria
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.63%
1/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.00%
0/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/158 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
0.64%
1/157 • From first intake of study medication, until 7 days after last intake of study medication, up to 92 days.
Treated Set: All participants who were treated with at least one dose of study medication.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER