Heart Failure With Reduced Ejection FractionPhase 3ERASENCT04600921

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

A Phase 3 study testing Ertugliflozin 5 mg in people with Heart Failure With Reduced Ejection Fraction and Heart Failure With Mid Range Ejection Fraction, run by Medical University of Graz at 8 sites in Austria.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The recent study is planned to investigate the impact of Ertugliflozin on total burden of ventricular arrhythmias. Further objectives will be number of therapeutic interventions of implanted devices, atrial fibrillation, heart failure biomarker and changes in physical function quality of life, stress and anxiety. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Implantable Cardioverter-Defibrillators
What is being tested?: Ertugliflozin 5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 8 sitesAustria
Study dates: 24 Jun 2021to 18 Oct 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

HFrEF or HFmrEF, and ICD±CRT therapy > 3 months
at least 10 documented VT episodes (either nsVT (non-sustained ventricular tachycardia) or sVT (sustained ventricular tachycardia) ± ICD (mplantable cardioverter-defibrillator) treatment) within the last 12 months plus:
nt-proBNP > 500pg/mL or
Left-ventricular Ejection Fraction (LV-EF) < 35% or
hospitalization for heart failure within the last 12 months or
> 100 nsVTs within the last 12 months

Show all 11Show fewer

> 1 sVT/VF (ventricular function) within the last 12 months
Informed consent has to be given in written form.
estimated glomerular filtration rate (eGFR) > 30 ml/min/1.73m2
Blood pressure before first drug dosing: blood pressure systolic > 100 mmHg
Blood pressure before first drug dosing: blood pressure diastolic > 60 mmHg

Who cannot join

Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
Ongoing ventricular arrhythmia
Known allergy to SGLT-2 inhibitors
Haemodynamic instability as defined by intravenous administration of catecholamine, calciumsensitizers or phosphodiesterase inhibitors
>1 episode of severe hypoglycemia within the last 6 months under treatment with insulin or sulfonylurea
Planned catheter ablation for ventricular arrhythmia
Planned explantation of ICD, or planned up/downgrade to/from CRT-D device
Existing therapy with SGLT-2 inhibitors

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Austria8 sites

Medical University of Graz
Graz, 8010
Universitätsklinikum Innsbruck
Innsbruck, 620
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Carinthia, 9020
Kepler Universitätsklinikum Linz
Linz, Upper Austria, 4021
Ordensklinikum Linz Elisabethinen
Linz, 4020
Medizinische Universität Wien, AKH Wien
Vienna, 1090
Wilhelminenspital
Vienna, 1160
Landesklinikum Wiener Neustadt
Wiener Neustadt, 2700

Other trials in Austria

About this study

Official title: Ertugliflozin to Reduce Arrhythmic Burden in Implantable Cardioverter-defibrillators (ICD)/Cardiac Resynchronisation Therapy(CRT) patientS (ERASe-Trial) - a Phase III Study

Read the detailed description

This is a randomized, double-blind (patients and physicians), placebo controlled multi-center study to evaluate the effect of ertugliflozin 5mg once daily (p.o.) for 52 weeks on the ventricular arrhythmic burden and markers of physical and mental well-being as well as biomarker for Heart Failure with reduced Ejection Fraction (HFrEF) and heart failure with mid-range ejection fraction (HFmrEF) patients with ICD±CRT therapy. The study will be conducted in 8 experienced sites in Austria with an aim to enrol 402 patients to evaluate the overall study hypothesis.

Therefore, three study visits will be carried out (baseline, 1-year follow-up visit and a telephone visit 4 weeks after visit 2). As part of the two on-site study visits, study-specific measures, a blood sample and an echocardiographic examination will be performed. The trial is completed by a telephone visit 4 weeks after the second on-site visit (week 52).

It is anticipated that the study will run for 30 months.

Conditions: Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy
Being tested: Ertugliflozin 5 mg, Placebo 5mg
Keywords: Ertugliflozin, Sodium dependent glucose transporter-2 inhibitor (SGLT-2), Heart failure, ICD, CRT, ventricular tachycardia (VT)
Medical subject headings: Heart Failure, Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ertugliflozin 5 mgDrug
Also called Steglatro
The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.
Placebo 5mgDrug
Also called Sugar pills
The subject will receive Placebo 5mg orally daily for 52 weeks.

Study groups in NCT04600921
Study group	Role	What they receive
Ertugliflozin	Active comparator	The subject will receive Ertugliflozin 5mg. Receives: Drug: Ertugliflozin 5 mg
Placebo	Placebo comparator	The subject will receive Placebo 5mg. Receives: Drug: Placebo 5mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Number of Supraventricular Tachycardia (svT)/ Ventricular Fibrillation (VF) Episodes
Change in number of supraventricular tachycardia (svT)/ ventricular fibrillation (VF) episodes from baseline to week 52
Measured: 52 weeks

Secondary outcomes (9)

Number of Nonsustained Ventricular Tachycardia (nsVT) Episodes
Number of nonsustained ventricular tachycardia (nsVT) episodes from baseline to week 52
Measured: 52 weeks
Number of Episodes of Appropriate Implantable Cardioverter-defibrillator Therapies
Number of episodes of appropriate Implantable cardioverter-defibrillator therapies from baseline to week 52.
Measured: 52 weeks
Change in NTproBNP Levels
Change in NTproBNP levels from baseline to week 52
Measured: 52 weeks
Change in HbA1c Levels
Change in HbA1c levels from baseline to week 52
Measured: 52 weeks
Number of Hospitalizations
Number of hospitalizations from baseline to week 56
Measured: 56 weeks
Atleast One Hospitalization Due to Heart Failure
It is the number of patients with at least one hospital re-admission due to heart failure from baseline to 56 weeks
Measured: 56 weeks
Number of Hospitalizations Due to Heart Failure
It is the number of hospital re-admissions due to heart failure from baseline to 56 weeks.
Measured: 56 weeks
Duration of Hospital Stay
It is the number of days of hospital stay from baseline to 56 weeks
Measured: 56 weeks
Cardiovascular Mortality
Difference in Cardiovascular mortality between treatment groups from randomisation to week 56
Measured: 56 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 202118 Oct 2023

First posted23 Oct 2020
Study start24 Jun 2021
Primary completion23 Jun 2023
Study completion18 Oct 2023

Why it stopped: The feasibility (recruitment) of the high number of patients (402 patients with HFrEF or HFmrEF) was impossible due to the rapid increase in SGLT2 inhibitors in patients with heart failure.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
More trials run by Medical University of GrazThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04600921
Sponsor's protocol ID: DvL-2020-01
Acronym: ERASE
Status last verified: Nov 2024
First submitted: 19 Oct 2020
Last updated: 3 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Benedikt M, Oulhaj A, Rohrer U, Manninger M, Tripolt NJ, Pferschy PN, Aziz F, Wallner M, Kolesnik E, Gwechenberger M, Martinek M, Nurnberg M, Roithinger FX, Steinwender C, Widkal J, Leiter S, Zirlik A, Stuhlinger M, Scherr D, Sourij H, von Lewinski D. Ertugliflozin to Reduce Arrhythmic Burden in Patients with ICDs/CRT-Ds. NEJM Evid. 2024 Oct;3(10):EVIDoa2400147. doi: 10.1056/EVIDoa2400147. Epub 2024 Sep 1.
PubMed 39217453
von Lewinski D, Tripolt NJ, Sourij H, Pferschy PN, Oulhaj A, Alber H, Gwechenberger M, Martinek M, Seidl S, Moertl D, Nurnberg M, Roithinger FX, Steinwender C, Stuhlinger M, Zirlik A, Benedikt M, Kolesnik E, Wallner M, Rohrer U, Manninger M, Scherr D; ERASe study group. Ertugliflozin to reduce arrhythmic burden in ICD/CRT patients (ERASe-trial) - A phase III study. Am Heart J. 2022 Apr;246:152-160. doi: 10.1016/j.ahj.2022.01.008. Epub 2022 Jan 16.
PubMed 35045327

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Recruiting
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure

All Heart Failure With Reduced Ejection Fraction trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ertugliflozin to Reduce Arrhythmic Burden in Implantable Cardioverter-defibrillators (ICD)/Cardiac Resynchronisation Therapy(CRT) patientS (ERASe-Trial) - a Phase III Study
ClinicalTrials.gov ID: NCT04600921
Acronym / sponsor ID: ERASE / DvL-2020-01
Conditions: Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy
Keywords: Ertugliflozin, Sodium dependent glucose transporter-2 inhibitor (SGLT-2), Heart failure, ICD, CRT, ventricular tachycardia (VT)
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The feasibility (recruitment) of the high number of patients (402 patients with HFrEF or HFmrEF) was impossible due to the rapid increase in SGLT2 inhibitors in patients with heart failure.
Enrolment: 55 participants (actual)
Lead sponsor: Medical University of GrazUniversity, hospital or other
Collaborators: Klinikum Klagenfurt am Wörthersee, Elisabethinen Hospital, Medical University Innsbruck, Medical University of Vienna, General Hospital Linz, Landesklinkum Wiener Neustadt, WiGeV Klinik Ottakring
Study start: 24 Jun 2021 (actual)
Primary completion: 23 Jun 2023 (actual)
Study completion: 18 Oct 2023 (actual)
First posted: 23 Oct 2020 (actual)
Results: Posted 3 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

It is anticipated that the study will run for 30 months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ertugliflozin	Active comparator	Drug: Ertugliflozin 5 mgThe subject will receive Ertugliflozin 5mg.
Placebo	Placebo comparator	Drug: Placebo 5mgThe subject will receive Placebo 5mg.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

HFrEF or HFmrEF, and ICD±CRT therapy > 3 months
at least 10 documented VT episodes (either nsVT (non-sustained ventricular tachycardia) or sVT (sustained ventricular tachycardia) ± ICD (mplantable cardioverter-defibrillator) treatment) within the last 12 months plus:
Informed consent has to be given in written form.
estimated glomerular filtration rate (eGFR) > 30 ml/min/1.73m2
Blood pressure before first drug dosing: blood pressure systolic > 100 mmHg

Key exclusion criteria (8 listed)

Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
Ongoing ventricular arrhythmia
Known allergy to SGLT-2 inhibitors
Haemodynamic instability as defined by intravenous administration of catecholamine, calciumsensitizers or phosphodiesterase inhibitors
>1 episode of severe hypoglycemia within the last 6 months under treatment with insulin or sulfonylurea

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ertugliflozin 5 mgAlso: SteglatroThe subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.	Drug	Ertugliflozin
Placebo 5mgAlso: Sugar pillsThe subject will receive Placebo 5mg orally daily for 52 weeks.	Drug	Placebo

Primary outcome

Change in Number of Supraventricular Tachycardia (svT)/ Ventricular Fibrillation (VF) Episodes
Time frame: 52 weeks
Change in number of supraventricular tachycardia (svT)/ ventricular fibrillation (VF) episodes from baseline to week 52

9 secondary outcomes

Number of Nonsustained Ventricular Tachycardia (nsVT) Episodes
Time frame: 52 weeks
Number of Episodes of Appropriate Implantable Cardioverter-defibrillator Therapies
Time frame: 52 weeks
Change in NTproBNP Levels
Time frame: 52 weeks
Change in HbA1c Levels
Time frame: 52 weeks
Number of Hospitalizations
Time frame: 56 weeks
Atleast One Hospitalization Due to Heart Failure
Time frame: 56 weeks
Number of Hospitalizations Due to Heart Failure
Time frame: 56 weeks
Duration of Hospital Stay
Time frame: 56 weeks
Cardiovascular Mortality
Time frame: 56 weeks

Results and safety

Results posted to the registry on 3 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ertugliflozin	25	22
Placebo	30	24

Primary outcome: Change in Number of Supraventricular Tachycardia (svT)/ Ventricular Fibrillation (VF) Episodes

Time frame: 52 weeks. Mean (Standard Deviation). Unit: Number of episode

Measure	Ertugliflozin n = 22	Placebo n = 24
Value	3 (6)	13 (34)

Ertugliflozin vs Placebo: Rate Ratio: 0.16 (95% CI 0.04 to 0.61), p <0.001, Negative binomial regression model

Population analysed: 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.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are recorded from baseline to 56 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ertugliflozin	10 of 25 (40%)	4 of 25 (16%)	3 of 25
Placebo	21 of 30 (70%)	2 of 30 (6.7%)	3 of 30

Limitations and caveats (from the sponsor): An important limitation is the lack of generalizability because our study predominantly included White men. A second limitation is that our trial was prematurely stopped, and thus we did not achieve the planned power to accurately assess our primary end point. In addition, seven patients withdrew their consent to continue in the trial. Therefore, the results of our primary and key secondary end points must be interpreted with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39217453Benedikt M, Oulhaj A, Rohrer U, Manninger M, Tripolt NJ, Pferschy PN, Aziz F, Wallner M, Kolesnik E, Gwechenberger M, Martinek M, Nurnberg M, Roithinger FX, Steinwender C, Widkal J, Leiter S, Zirlik A, Stuhlinger M, Scherr D, Sourij H, von Lewinski D. Ertugliflozin to Reduce Arrhythmic Burden in Patients with ICDs/CRT-Ds. NEJM Evid. 2024 Oct;3(10):EVIDoa2400147. doi: 10.1056/EVIDoa2400147. Epub 2024 Sep 1.
Derived from this study: PubMed 35045327von Lewinski D, Tripolt NJ, Sourij H, Pferschy PN, Oulhaj A, Alber H, Gwechenberger M, Martinek M, Seidl S, Moertl D, Nurnberg M, Roithinger FX, Steinwender C, Stuhlinger M, Zirlik A, Benedikt M, Kolesnik E, Wallner M, Rohrer U, Manninger M, Scherr D; ERASe study group. Ertugliflozin to reduce arrhythmic burden in ICD/CRT patients (ERASe-trial) - A phase III study. Am Heart J. 2022 Apr;246:152-160. doi: 10.1016/j.ahj.2022.01.008. Epub 2022 Jan 16.

Related trials for Heart Failure With Reduced Ejection Fraction

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dirk von Lewinski, Assoc-Prof. principal investigator

Medical University of Graz

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Number of Supraventricular Tachycardia (svT)/ Ventricular Fibrillation (VF) Episodes (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04600921, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.