Trial Outcomes & Findings for Are the "Cardiac Benefits" of Empagliflozin Independent of Its Hypoglycemic Activity? (ATRU-4). (NCT NCT03485222)
NCT ID: NCT03485222
Last Updated: 2021-03-25
Results Overview
End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction of the left ventricle (LV). Change from baseline to study end at 6 months.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
84 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2021-03-25
Participant Flow
Participant milestones
| Measure |
Empagliflozin
10mg once a day for 6 months
|
Placebos
Placebo equivalent once a day for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Empagliflozin
10mg once a day for 6 months
|
Placebos
Placebo equivalent once a day for 6 months
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Are the "Cardiac Benefits" of Empagliflozin Independent of Its Hypoglycemic Activity? (ATRU-4).
Baseline characteristics by cohort
| Measure |
Empagliflozin
n=42 Participants
10mg once a day for 6 months
|
Placebos
n=42 Participants
Placebo equivalent once a day for 6 months
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
62 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Age, Customized
<65 yrs
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Customized
>65 yrs
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Hypertension
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Hyperlipidemia
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Cigarette smoking (past or present)
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Atrial fibrillation
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Cause of Heart Failure (HF)
Ischemic
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Cause of Heart Failure (HF)
Nonischemic
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Devices
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Statin History
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Number of participants taking ACE inhibitor/ARB (alone) at baseline
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Angiotensin receptor-neprilysin inhibitor (ARNi)
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
B-blockers
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Loop diuretics
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Thiazide diuretics
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Mineralocorticoid antagonists
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ca-blockers
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Antiplatelet
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Anticoagulants
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsEnd-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction of the left ventricle (LV). Change from baseline to study end at 6 months.
Outcome measures
| Measure |
Empagliflozin
n=40 Participants
10mg once a day for 6 months
|
Placebos
n=40 Participants
Placebo equivalent once a day for 6 months
|
|---|---|---|
|
Change in Left Ventricle-end Systolic Volume (ESV)
|
-26.6 ml
Standard Deviation 20.5
|
-0.5 ml
Standard Deviation 21.9
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsEnd-diastolic volume (EDV) is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. Change from baseline to study end at 6 months.
Outcome measures
| Measure |
Empagliflozin
n=40 Participants
10mg once a day for 6 months
|
Placebos
n=40 Participants
Placebo equivalent once a day for 6 months
|
|---|---|---|
|
Change in LV-end Diastolic Volume (EDV)
|
-25.1 ml
Standard Deviation 26
|
-1.5 ml
Standard Deviation 25.4
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsThe volumetric fraction of blood ejected from the left ventricle of the heart with each heartbeat. Change from baseline to study end at 6 months.
Outcome measures
| Measure |
Empagliflozin
n=40 Participants
10mg once a day for 6 months
|
Placebos
n=40 Participants
Placebo equivalent once a day for 6 months
|
|---|---|---|
|
Change in LV-Ejection Fraction Index
|
6.0 percent ejection fraction
Standard Deviation 4.2
|
-0.1 percent ejection fraction
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsOxygen consumption - the amount of oxygen consumed by the tissues of the body, usually measured as the oxygen uptake in the lung, also called the V02max measure. Change from baseline to study end at 6 months.
Outcome measures
| Measure |
Empagliflozin
n=40 Participants
10mg once a day for 6 months
|
Placebos
n=40 Participants
Placebo equivalent once a day for 6 months
|
|---|---|---|
|
Change in VO2 Consumption
|
1.1 ml/min/kg
Standard Deviation 2.6
|
-0.5 ml/min/kg
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsThe distance covered over a time of 6 minutes. Change from baseline to study end at 6 months.
Outcome measures
| Measure |
Empagliflozin
n=40 Participants
10mg once a day for 6 months
|
Placebos
n=40 Participants
Placebo equivalent once a day for 6 months
|
|---|---|---|
|
Change in 6 Min Walk Test
|
81 m
Standard Deviation 64
|
-35 m
Standard Deviation 68
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsThe KCCQ-12 is an instrument most widely used to evaluate QoL in Heart Failure (HF) patients. It is a questionnaire containing 12 questions with full scores ranging from 12 (poor quality of life) to 70 (good quality of life). Higher score indicates better quality of life. Change from baseline to study end at 6 months.
Outcome measures
| Measure |
Empagliflozin
n=40 Participants
10mg once a day for 6 months
|
Placebos
n=40 Participants
Placebo equivalent once a day for 6 months
|
|---|---|---|
|
Change in Kansas Cardiomyopathy Questionnaire (KCCQ-12)
|
21 score on a scale
Standard Deviation 18
|
1.9 score on a scale
Standard Deviation 15
|
Adverse Events
Empagliflozin
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebos
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Empagliflozin
n=40 participants at risk
10mg once a day for 6 months
|
Placebos
n=40 participants at risk
Placebo equivalent once a day for 6 months
|
|---|---|---|
|
Cardiac disorders
Malignant Ventricular Tachycardia
|
2.5%
1/40 • 6 months
|
0.00%
0/40 • 6 months
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/40 • 6 months
|
5.0%
2/40 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/40 • 6 months
|
5.0%
2/40 • 6 months
|
|
Cardiac disorders
Worsening Heart Failure
|
0.00%
0/40 • 6 months
|
2.5%
1/40 • 6 months
|
|
Cardiac disorders
New ICD Implant
|
2.5%
1/40 • 6 months
|
5.0%
2/40 • 6 months
|
|
Cardiac disorders
New Cardiomems Implant
|
2.5%
1/40 • 6 months
|
0.00%
0/40 • 6 months
|
Other adverse events
| Measure |
Empagliflozin
n=40 participants at risk
10mg once a day for 6 months
|
Placebos
n=40 participants at risk
Placebo equivalent once a day for 6 months
|
|---|---|---|
|
Hepatobiliary disorders
Hepatic Injury
|
0.00%
0/40 • 6 months
|
2.5%
1/40 • 6 months
|
|
Nervous system disorders
Migraine
|
2.5%
1/40 • 6 months
|
0.00%
0/40 • 6 months
|
|
Social circumstances
Motor Vehicle Accident
|
2.5%
1/40 • 6 months
|
0.00%
0/40 • 6 months
|
Additional Information
Dr. Juan Badimon
Icahn School of Medicine at Mount Sinai
Phone: (212) 241-8484
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place