Trial Outcomes & Findings for Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study (NCT NCT04600921)

NCT ID: NCT04600921

Last Updated: 2025-06-03

Results Overview

Change in number of supraventricular tachycardia (svT)/ ventricular fibrillation (VF) episodes from baseline to week 52

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

55 participants

Primary outcome timeframe

52 weeks

Results posted on

2025-06-03

Participant Flow

Participant milestones

Participant milestones
Measure	Ertugliflozin The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally daily for 52 weeks.
Overall Study STARTED	25	30
Overall Study COMPLETED	22	24
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Ertugliflozin The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally daily for 52 weeks.
Overall Study Withdrawal by Subject	3	5
Overall Study Death	0	1

Baseline Characteristics

Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ertugliflozin n=22 Participants The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo n=24 Participants The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally once daily for 52 weeks.	Total n=46 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 11 • n=99 Participants	66 years STANDARD_DEVIATION 12 • n=107 Participants	65 years STANDARD_DEVIATION 11 • n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Sex: Female, Male Male	20 Participants n=99 Participants	22 Participants n=107 Participants	42 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	22 Participants n=99 Participants	24 Participants n=107 Participants	46 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Austria	22 Participants n=99 Participants	24 Participants n=107 Participants	46 Participants n=206 Participants
Body Mass Index (BMI)	28.6 kg/m² STANDARD_DEVIATION 5.3 • n=99 Participants	28.2 kg/m² STANDARD_DEVIATION 6.3 • n=107 Participants	28.4 kg/m² STANDARD_DEVIATION 5.8 • n=206 Participants
Systolic blood pressure	136 mmHg STANDARD_DEVIATION 13 • n=99 Participants	131 mmHg STANDARD_DEVIATION 21 • n=107 Participants	133 mmHg STANDARD_DEVIATION 18 • n=206 Participants
Diastolic blood pressure	87 mmHg STANDARD_DEVIATION 12 • n=99 Participants	81 mmHg STANDARD_DEVIATION 15 • n=107 Participants	84 mmHg STANDARD_DEVIATION 14 • n=206 Participants
Heart rate	68 beats/minute STANDARD_DEVIATION 12 • n=99 Participants	72 beats/minute STANDARD_DEVIATION 13 • n=107 Participants	70 beats/minute STANDARD_DEVIATION 13 • n=206 Participants
Baseline medications Angiotensin-converting enzyme inhibitor/ Angiotensin receptor blocker	13 Participants n=99 Participants	12 Participants n=107 Participants	25 Participants n=206 Participants
Baseline medications Beta-blockers	18 Participants n=99 Participants	21 Participants n=107 Participants	39 Participants n=206 Participants
Baseline medications Mineralocorticoid receptor blocker	12 Participants n=99 Participants	14 Participants n=107 Participants	26 Participants n=206 Participants
Baseline medications Angiotensin receptor blocker and neprilysin inhibitor	6 Participants n=99 Participants	8 Participants n=107 Participants	14 Participants n=206 Participants
Baseline medications Loop diuretics	9 Participants n=99 Participants	15 Participants n=107 Participants	24 Participants n=206 Participants
Baseline medications Dihydropyridine (CCB)	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Baseline medications Verapamil/Diltiazem (CCB)	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Baseline medications Digitalis	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Baseline medications Amiodarone/sotalol	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants
Baseline medications Supplemental Magnesium	6 Participants n=99 Participants	5 Participants n=107 Participants	11 Participants n=206 Participants
Baseline medications Platelet aggregation inhibitors	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants
Baseline medications Anticoagulants	15 Participants n=99 Participants	12 Participants n=107 Participants	27 Participants n=206 Participants
Baseline medications Statins	14 Participants n=99 Participants	15 Participants n=107 Participants	29 Participants n=206 Participants
Baseline arrhythmic burden, 12 months prior Sustained ventricular tachycardia or Ventricular fibrillation	19 Number of episodes STANDARD_DEVIATION 44 • n=99 Participants	6 Number of episodes STANDARD_DEVIATION 10 • n=107 Participants	12 Number of episodes STANDARD_DEVIATION 32 • n=206 Participants
Baseline arrhythmic burden, 12 months prior Non-sustained Ventricular tachycardia episodes	22 Number of episodes STANDARD_DEVIATION 33 • n=99 Participants	27 Number of episodes STANDARD_DEVIATION 57 • n=107 Participants	25 Number of episodes STANDARD_DEVIATION 47 • n=206 Participants
Left ventricular ejection fraction, 12 months prior	36 percentage STANDARD_DEVIATION 8 • n=99 Participants	38 percentage STANDARD_DEVIATION 14 • n=107 Participants	37 percentage STANDARD_DEVIATION 11 • n=206 Participants
Potassium concentration	4.5 mmol/l STANDARD_DEVIATION 0.6 • n=99 Participants	4.5 mmol/l STANDARD_DEVIATION 0.50 • n=107 Participants	4.5 mmol/l STANDARD_DEVIATION 0.5 • n=206 Participants
Magnesium concentration	0.9 mmol/l STANDARD_DEVIATION 0.1 • n=99 Participants	0.8 mmol/l STANDARD_DEVIATION 0.1 • n=107 Participants	0.9 mmol/l STANDARD_DEVIATION 0.1 • n=206 Participants
C-reactive protein level	3 mg/l STANDARD_DEVIATION 3 • n=99 Participants	2 mg/l STANDARD_DEVIATION 2 • n=107 Participants	2 mg/l STANDARD_DEVIATION 3 • n=206 Participants
Estimated glomerular filtration rate	65 ml/min/1.73m² STANDARD_DEVIATION 21 • n=99 Participants	57 ml/min/1.73m² STANDARD_DEVIATION 16 • n=107 Participants	61 ml/min/1.73m² STANDARD_DEVIATION 18 • n=206 Participants
NTproBNP levels	1141 ng/l STANDARD_DEVIATION 1598 • n=99 Participants	2370 ng/l STANDARD_DEVIATION 2714 • n=107 Participants	1782 ng/l STANDARD_DEVIATION 2311 • n=206 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: We randomized 55 patients, 25 in the ertugliflozin group and 30 in the placebo group. 5 patients from the placebo group and 3 from the placebo group withdrew consent before termination of the trial. 1 patient from the placebo group died without sufficient telemetric data. Consequently, only 46 patients were analysed including 22 in the ertugliflozin group and 24 in the placebo group.

Change in number of supraventricular tachycardia (svT)/ ventricular fibrillation (VF) episodes from baseline to week 52

Outcome measures

Outcome measures
Measure	Ertugliflozin n=22 Participants The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo n=24 Participants The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally once daily for 52 weeks.
Change in Number of Supraventricular Tachycardia (svT)/ Ventricular Fibrillation (VF) Episodes	3 Number of episode Standard Deviation 6	13 Number of episode Standard Deviation 34

SECONDARY outcome

Timeframe: 52 weeks

Number of nonsustained ventricular tachycardia (nsVT) episodes from baseline to week 52

Outcome measures

Outcome measures
Measure	Ertugliflozin n=22 Participants The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo n=24 Participants The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally once daily for 52 weeks.
Number of Nonsustained Ventricular Tachycardia (nsVT) Episodes	28 Number of episodes Standard Deviation 54	130 Number of episodes Standard Deviation 322

SECONDARY outcome

Timeframe: 52 weeks

Number of episodes of appropriate Implantable cardioverter-defibrillator therapies from baseline to week 52.

Outcome measures

Outcome measures
Measure	Ertugliflozin n=22 Participants The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo n=24 Participants The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally once daily for 52 weeks.
Number of Episodes of Appropriate Implantable Cardioverter-defibrillator Therapies	5 Number of ICD therapies Standard Deviation 8	10 Number of ICD therapies Standard Deviation 33

SECONDARY outcome

Timeframe: 52 weeks

Change in NTproBNP levels from baseline to week 52

Outcome measures

Outcome measures
Measure	Ertugliflozin n=22 Participants The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo n=24 Participants The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally once daily for 52 weeks.
Change in NTproBNP Levels	143 ng/l Interval -6.0 to 300.0	101 ng/l Interval -103.0 to 322.0

SECONDARY outcome

Timeframe: 52 weeks

Change in HbA1c levels from baseline to week 52

Outcome measures

Outcome measures
Measure	Ertugliflozin n=22 Participants The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo n=24 Participants The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally once daily for 52 weeks.
Change in HbA1c Levels	-0.9 mmol/mol Standard Deviation 5.1	-1.33 mmol/mol Standard Deviation 4.9

SECONDARY outcome

Timeframe: 56 weeks

Number of hospitalizations from baseline to week 56

Outcome measures

Outcome measures
Measure	Ertugliflozin n=22 Participants The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo n=24 Participants The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally once daily for 52 weeks.
Number of Hospitalizations	0.7 number of hospitalizations Standard Deviation 1.0	1.3 number of hospitalizations Standard Deviation 2.2

SECONDARY outcome

Timeframe: 56 weeks

It is the number of patients with at least one hospital re-admission due to heart failure from baseline to 56 weeks

Outcome measures

Outcome measures
Measure	Ertugliflozin n=22 Participants The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo n=24 Participants The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally once daily for 52 weeks.
Atleast One Hospitalization Due to Heart Failure	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 56 weeks

It is the number of hospital re-admissions due to heart failure from baseline to 56 weeks.

Outcome measures

Outcome measures
Measure	Ertugliflozin n=22 Participants The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo n=24 Participants The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally once daily for 52 weeks.
Number of Hospitalizations Due to Heart Failure	1 Number of patients	12 Number of patients

SECONDARY outcome

Timeframe: 56 weeks

It is the number of days of hospital stay from baseline to 56 weeks

Outcome measures

Outcome measures
Measure	Ertugliflozin n=22 Participants The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo n=24 Participants The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally once daily for 52 weeks.
Duration of Hospital Stay	3.6 Number of days Standard Deviation 5.3	10.4 Number of days Standard Deviation 23.5

SECONDARY outcome

Timeframe: 56 weeks

Difference in Cardiovascular mortality between treatment groups from randomisation to week 56

Outcome measures

Outcome measures
Measure	Ertugliflozin n=22 Participants The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo n=24 Participants The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally once daily for 52 weeks.
Cardiovascular Mortality	0 Participants	2 Participants

Adverse Events

Ertugliflozin

Serious events: 10 serious events

Other events: 4 other events

Deaths: 3 deaths

Placebo

Serious events: 21 serious events

Other events: 2 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Ertugliflozin n=25 participants at risk The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo n=30 participants at risk The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally daily for 52 weeks.
Cardiac disorders Hospitalization due to cardiovascular event	12.0% 3/25 • Number of events 5 • Adverse events are recorded from baseline to 56 weeks	13.3% 4/30 • Number of events 5 • Adverse events are recorded from baseline to 56 weeks
Cardiac disorders Cardiovascular death	4.0% 1/25 • Adverse events are recorded from baseline to 56 weeks	6.7% 2/30 • Adverse events are recorded from baseline to 56 weeks
General disorders Hospitalization due to non-cardiovascular causes	8.0% 2/25 • Number of events 2 • Adverse events are recorded from baseline to 56 weeks	23.3% 7/30 • Number of events 9 • Adverse events are recorded from baseline to 56 weeks
General disorders Non-cardiovascular death	8.0% 2/25 • Adverse events are recorded from baseline to 56 weeks	3.3% 1/30 • Adverse events are recorded from baseline to 56 weeks
Infections and infestations Infectious disease	4.0% 1/25 • Number of events 1 • Adverse events are recorded from baseline to 56 weeks	10.0% 3/30 • Number of events 3 • Adverse events are recorded from baseline to 56 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.00% 0/25 • Adverse events are recorded from baseline to 56 weeks	6.7% 2/30 • Number of events 2 • Adverse events are recorded from baseline to 56 weeks
Nervous system disorders Seizure	4.0% 1/25 • Number of events 1 • Adverse events are recorded from baseline to 56 weeks	0.00% 0/30 • Adverse events are recorded from baseline to 56 weeks
General disorders Any Hospitalization	40.0% 10/25 • Number of events 12 • Adverse events are recorded from baseline to 56 weeks	70.0% 21/30 • Number of events 33 • Adverse events are recorded from baseline to 56 weeks
General disorders Death	12.0% 3/25 • Adverse events are recorded from baseline to 56 weeks	10.0% 3/30 • Adverse events are recorded from baseline to 56 weeks

Other adverse events

Other adverse events
Measure	Ertugliflozin n=25 participants at risk The subject will receive Ertugliflozin 5mg. Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Placebo n=30 participants at risk The subject will receive Placebo 5mg. Placebo 5mg: The subject will receive Placebo 5mg orally daily for 52 weeks.
Hepatobiliary disorders Hepatic Injury	0.00% 0/25 • Adverse events are recorded from baseline to 56 weeks	0.00% 0/30 • Adverse events are recorded from baseline to 56 weeks
General disorders Renal Injury	0.00% 0/25 • Adverse events are recorded from baseline to 56 weeks	3.3% 1/30 • Adverse events are recorded from baseline to 56 weeks
Metabolism and nutrition disorders Metabolic acidosis and diabetic ketoacidosis	0.00% 0/25 • Adverse events are recorded from baseline to 56 weeks	0.00% 0/30 • Adverse events are recorded from baseline to 56 weeks
Musculoskeletal and connective tissue disorders Event involving lower limb amputation	0.00% 0/25 • Adverse events are recorded from baseline to 56 weeks	0.00% 0/30 • Adverse events are recorded from baseline to 56 weeks
Infections and infestations Urinary tract infection	4.0% 1/25 • Number of events 1 • Adverse events are recorded from baseline to 56 weeks	0.00% 0/30 • Adverse events are recorded from baseline to 56 weeks
Infections and infestations Genital fungal infection	4.0% 1/25 • Number of events 6 • Adverse events are recorded from baseline to 56 weeks	3.3% 1/30 • Number of events 4 • Adverse events are recorded from baseline to 56 weeks
Blood and lymphatic system disorders Hypotension	4.0% 1/25 • Number of events 1 • Adverse events are recorded from baseline to 56 weeks	0.00% 0/30 • Adverse events are recorded from baseline to 56 weeks
General disorders Polyuria	4.0% 1/25 • Number of events 1 • Adverse events are recorded from baseline to 56 weeks	0.00% 0/30 • Adverse events are recorded from baseline to 56 weeks
Metabolism and nutrition disorders Total Hypoglycemia	0.00% 0/25 • Adverse events are recorded from baseline to 56 weeks	0.00% 0/30 • Adverse events are recorded from baseline to 56 weeks

Additional Information

Dr. Dirk von Lewinski

Department of Internal Medicine, Division of Cardiology, Medical University of Graz

Phone: +4331638580684

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place