Trial Outcomes & Findings for Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure (NCT NCT03200860)

NCT ID: NCT03200860

Last Updated: 2024-04-17

Results Overview

Change in Dyspnea on VAS analogue scale (AUC) VAS Score is a measure/scale where patients on a scale from 0 to 100 can assign their current dyspnea score. 0 means there can be no worse dyspnea, 100 means it cannot get any better (perfect). The change in Dyspnea VAS means higher score is better outcomes. Individual changes in VAS score are be visualized (virtually) as a curve where the X-axis shows study day baseline to day 4, and y-axis shows VAS score. Using this approach, area under the curves for each study day (trapezoids) can be calculated, and added together, resulting in an overall VAS AUC score (mmxh) and change in VAS can be caculated

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 80 participants
• Primary outcome timeframe: From baseline to Day 4
• Results posted on: 2024-04-17

Participant Flow

Participant milestones

Measure	Empagliflozin Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days	Placebo Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days
Overall Study STARTED	41	39
Overall Study COMPLETED	40	39
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Empagliflozin Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days	Placebo Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure

Baseline characteristics by cohort

Measure	Empagliflozin n=40 Participants Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days	Placebo n=39 Participants Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days	Total n=79 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants	27 Participants n=7 Participants	63 Participants n=5 Participants
Age, Continuous	79 years n=5 Participants	73 years n=7 Participants	76 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	29 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Netherlands	40 participants n=5 Participants	39 participants n=7 Participants	79 participants n=5 Participants
NTproBNP	4406 pg/mL n=5 Participants	6168 pg/mL n=7 Participants	4918 pg/mL n=5 Participants

PRIMARY outcome

Timeframe: From baseline to Day 4

Change in Dyspnea on VAS analogue scale (AUC)

VAS Score is a measure/scale where patients on a scale from 0 to 100 can assign their current dyspnea score. 0 means there can be no worse dyspnea, 100 means it cannot get any better (perfect).

The change in Dyspnea VAS means higher score is better outcomes.

Individual changes in VAS score are be visualized (virtually) as a curve where the X-axis shows study day baseline to day 4, and y-axis shows VAS score. Using this approach, area under the curves for each study day (trapezoids) can be calculated, and added together, resulting in an overall VAS AUC score (mmxh) and change in VAS can be caculated

Outcome measures

Measure	Empagliflozin n=37 Participants Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days	Placebo n=36 Participants Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days
Dyspnea	1264 mmxh Standard Deviation 1211	1650 mmxh Standard Deviation 1240

PRIMARY outcome

Timeframe: Total weight change from baseline to Day 4

Weight change from baseline per 40 mg of Furosemide equivalent

Outcome measures

Measure	Empagliflozin n=36 Participants Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days	Placebo n=37 Participants Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days
Diuretic Response	-0.35 kg/40 mg Furosemide equivalent at day 4 Standard Deviation 0.44	-0.12 kg/40 mg Furosemide equivalent at day 4 Standard Deviation 1.52

PRIMARY outcome

Timeframe: within 60 days

Hospital stay of Index admission

Outcome measures

Measure	Empagliflozin n=39 Participants Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days	Placebo n=38 Participants Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days
Length of Stay	8 days Interval 6.0 to 10.0	8 days Interval 6.0 to 9.0

PRIMARY outcome

Timeframe: From baseline to Day 4

Change in NTproBNP

Outcome measures

Measure	Empagliflozin n=37 Participants Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days	Placebo n=34 Participants Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days
Plasma NTproBNP	-46 % change in NTproBNP at day 4 Standard Deviation 32	-42 % change in NTproBNP at day 4 Standard Deviation 31

SECONDARY outcome

Timeframe: Day 30

Death and/or heart failure re-admission at day 30

Outcome measures

Measure	Empagliflozin n=40 Participants Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days	Placebo n=39 Participants Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days
Death and/or Heart Failure Re-admission	3 Participants	6 Participants

SECONDARY outcome

Timeframe: 60 days

Inhospital Worsening Heart Failure or All Cause mortality or Heart Failure Readmission at day 60

Outcome measures

Measure	Empagliflozin n=40 Participants Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days	Placebo n=39 Participants Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days
Inhospital Worsening Heart Failure, All Cause Mortality or Heart Failure Readmission at Day 60	4 Participants	13 Participants

SECONDARY outcome

Timeframe: 60 day

All Cause Mortality at 60 days

Outcome measures

Measure	Empagliflozin n=40 Participants Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days	Placebo n=39 Participants Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days
All Cause Mortality	1 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 days

SAE including all cause mortality. Per request Clintrials.gov different from Protocol definition

Outcome measures

Measure	Empagliflozin n=40 Participants Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days	Placebo n=39 Participants Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days
Serious Adverse Events Cardiovascular	4 Participants	8 Participants
Serious Adverse Events Respiratory/Pulmonary	0 Participants	1 Participants
Serious Adverse Events Renal/Urinary	2 Participants	0 Participants
Serious Adverse Events Psychiatric	0 Participants	1 Participants
Serious Adverse Events Infectious	1 Participants	0 Participants
Serious Adverse Events Other	1 Participants	0 Participants
Serious Adverse Events All Cause Mortality	1 Participants	3 Participants

Adverse Events

Empagliflozin

Serious events: 8 serious events

Other events: 29 other events

Deaths: 1 deaths

Placebo

Serious events: 10 serious events

Other events: 31 other events

Deaths: 3 deaths

Serious adverse events

Measure	Empagliflozin n=40 participants at risk Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days	Placebo n=39 participants at risk Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days
Cardiac disorders Worsening Heart Failure	7.5% 3/40 • Number of events 3 • 60 days	10.3% 4/39 • Number of events 4 • 60 days
General disorders Worsening Renal Function	2.5% 1/40 • Number of events 1 • 60 days	0.00% 0/39 • 60 days
General disorders Acute Kidney Injury	2.5% 1/40 • Number of events 1 • 60 days	0.00% 0/39 • 60 days
Injury, poisoning and procedural complications Angioedema	2.5% 1/40 • Number of events 1 • 60 days	0.00% 0/39 • 60 days
Cardiac disorders Hypovolemic shock	0.00% 0/40 • 60 days	2.6% 1/39 • Number of events 1 • 60 days
General disorders Delirium	0.00% 0/40 • 60 days	2.6% 1/39 • Number of events 1 • 60 days
Cardiac disorders Heart Failure	0.00% 0/40 • 60 days	2.6% 1/39 • Number of events 1 • 60 days
Cardiac disorders Atrial Fibrillation	0.00% 0/40 • 60 days	2.6% 1/39 • Number of events 1 • 60 days
Infections and infestations S. Aureus Bacteremia	2.5% 1/40 • Number of events 1 • 60 days	0.00% 0/39 • 60 days
Cardiac disorders Syncope	2.5% 1/40 • Number of events 1 • 60 days	2.6% 1/39 • Number of events 1 • 60 days
General disorders Respiratory Failure	0.00% 0/40 • 60 days	2.6% 1/39 • Number of events 1 • 60 days

Other adverse events

Measure	Empagliflozin n=40 participants at risk Empagliflozin 10 mg daily, oral, 30 days Empagliflozin 10 MG: 10 mg daily, oral, 30 days	Placebo n=39 participants at risk Matching Placebo 10 mg daily, oral, 30 days Placebo Oral Tablet: Matching Placebo, 10 mg daily, oral, 30 days
Blood and lymphatic system disorders Cardiovascular	22.5% 9/40 • Number of events 9 • 60 days	43.6% 17/39 • Number of events 17 • 60 days
General disorders Respiratory	7.5% 3/40 • Number of events 3 • 60 days	5.1% 2/39 • Number of events 2 • 60 days
Gastrointestinal disorders Gastrointestinal	15.0% 6/40 • Number of events 6 • 60 days	23.1% 9/39 • Number of events 9 • 60 days
General disorders Renal/Urinary	37.5% 15/40 • Number of events 15 • 60 days	33.3% 13/39 • Number of events 13 • 60 days
Metabolism and nutrition disorders Metabolic	22.5% 9/40 • Number of events 9 • 60 days	23.1% 9/39 • Number of events 9 • 60 days
Musculoskeletal and connective tissue disorders Musculoskeletal	32.5% 13/40 • Number of events 13 • 60 days	33.3% 13/39 • Number of events 13 • 60 days
General disorders Other	15.0% 6/40 • Number of events 6 • 60 days	17.9% 7/39 • Number of events 7 • 60 days

Additional Information

Prof. dr. A.A. Voors

University Medical Center Groningen - Department of Cardiology

Phone: 0031503616161

Email: a.a.voors@umcg.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place