Trial · NCT04600921
Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study
NCT04600921, Phase 3, Terminated, Medical University of Graz; results first posted 2025-06-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study. Trials, record NCT04600921. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04600921
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study
- NCT number
- NCT04600921
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 55 participants, actual
- Lead sponsor
- Medical University of Graz
- Conditions
- Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy
- Interventions
- Ertugliflozin 5 mg, Placebo 5mg
- First posted
- 2020-10-23
- Last updated
- 2025-06-03
- Results first posted
- 2025-06-03
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Number of Supraventricular Tachycardia (svT)/ Ventricular Fibrillation (VF) Episodes | 52 weeks | Change in number of supraventricular tachycardia (svT)/ ventricular fibrillation (VF) episodes from baseline to week 52 |
| Secondary | Number of Nonsustained Ventricular Tachycardia (nsVT) Episodes | 52 weeks | Number of nonsustained ventricular tachycardia (nsVT) episodes from baseline to week 52 |
| Secondary | Number of Episodes of Appropriate Implantable Cardioverter-defibrillator Therapies | 52 weeks | Number of episodes of appropriate Implantable cardioverter-defibrillator therapies from baseline to week 52. |
| Secondary | Change in NTproBNP Levels | 52 weeks | Change in NTproBNP levels from baseline to week 52 |
| Secondary | Change in HbA1c Levels | 52 weeks | Change in HbA1c levels from baseline to week 52 |
| Secondary | Number of Hospitalizations | 56 weeks | Number of hospitalizations from baseline to week 56 |
| Secondary | Atleast One Hospitalization Due to Heart Failure | 56 weeks | It is the number of patients with at least one hospital re-admission due to heart failure from baseline to 56 weeks |
| Secondary | Number of Hospitalizations Due to Heart Failure | 56 weeks | It is the number of hospital re-admissions due to heart failure from baseline to 56 weeks. |
| Secondary | Duration of Hospital Stay | 56 weeks | It is the number of days of hospital stay from baseline to 56 weeks |
| Secondary | Cardiovascular Mortality | 56 weeks | Difference in Cardiovascular mortality between treatment groups from randomisation to week 56 |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Number of Supraventricular Tachycardia (svT)/ Ventricular Fibrillation (VF) Episodes | 52 weeks | 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. | Number of episode | MEAN |
| SECONDARY | Number of Nonsustained Ventricular Tachycardia (nsVT) Episodes | 52 weeks | Number of episodes | MEAN | |
| SECONDARY | Number of Episodes of Appropriate Implantable Cardioverter-defibrillator Therapies | 52 weeks | Number of ICD therapies | MEAN | |
| SECONDARY | Change in NTproBNP Levels | 52 weeks | ng/l | MEDIAN | |
| SECONDARY | Change in HbA1c Levels | 52 weeks | mmol/mol | MEAN | |
| SECONDARY | Number of Hospitalizations | 56 weeks | number of hospitalizations | MEAN | |
| SECONDARY | Atleast One Hospitalization Due to Heart Failure | 56 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Hospitalizations Due to Heart Failure | 56 weeks | Number of patients | NUMBER | |
| SECONDARY | Duration of Hospital Stay | 56 weeks | Number of days | MEAN | |
| SECONDARY | Cardiovascular Mortality | 56 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Number of Supraventricular Tachycardia (svT)/ Ventricular Fibrillation (VF) Episodes | Ertugliflozin | 3 | Standard Deviation 6 | Number of episode | |
| Change in Number of Supraventricular Tachycardia (svT)/ Ventricular Fibrillation (VF) Episodes | Placebo | 13 | Standard Deviation 34 | Number of episode | |
| Number of Nonsustained Ventricular Tachycardia (nsVT) Episodes | Ertugliflozin | 28 | Standard Deviation 54 | Number of episodes | |
| Number of Nonsustained Ventricular Tachycardia (nsVT) Episodes | Placebo | 130 | Standard Deviation 322 | Number of episodes | |
| Number of Episodes of Appropriate Implantable Cardioverter-defibrillator Therapies | Ertugliflozin | 5 | Standard Deviation 8 | Number of ICD therapies | |
| Number of Episodes of Appropriate Implantable Cardioverter-defibrillator Therapies | Placebo | 10 | Standard Deviation 33 | Number of ICD therapies | |
| Change in NTproBNP Levels | Ertugliflozin | 143 | Inter-Quartile Range -6 to 300 | ng/l | |
| Change in NTproBNP Levels | Placebo | 101 | Inter-Quartile Range -103 to 322 | ng/l | |
| Change in HbA1c Levels | Ertugliflozin | -0.9 | Standard Deviation 5.1 | mmol/mol | |
| Change in HbA1c Levels | Placebo | -1.33 | Standard Deviation 4.9 | mmol/mol |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ertugliflozin | 25 | |
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | COMPLETED | Ertugliflozin | 22 | |
| Overall Study | COMPLETED | Placebo | 24 | |
| Overall Study | NOT COMPLETED | Ertugliflozin | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hepatic Injury | Hepatobiliary disorders | Ertugliflozin | 0 | 25 | |
| other | Hepatic Injury | Hepatobiliary disorders | Placebo | 0 | 30 | |
| other | Renal Injury | General disorders | Ertugliflozin | 0 | 25 | |
| other | Renal Injury | General disorders | Placebo | 1 | 30 | |
| other | Metabolic acidosis and diabetic ketoacidosis | Metabolism and nutrition disorders | Ertugliflozin | 0 | 25 | |
| other | Metabolic acidosis and diabetic ketoacidosis | Metabolism and nutrition disorders | Placebo | 0 | 30 | |
| other | Event involving lower limb amputation | Musculoskeletal and connective tissue disorders | Ertugliflozin | 0 | 25 | |
| other | Event involving lower limb amputation | Musculoskeletal and connective tissue disorders | Placebo | 0 | 30 | |
| other | Urinary tract infection | Infections and infestations | Ertugliflozin | 1 | 25 | 1 |
| other | Urinary tract infection | Infections and infestations | Placebo | 0 | 30 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ertugliflozin | 3 | 25 |
| Total, all-cause mortality | Placebo | 3 | 30 |
| Total, other adverse events | Ertugliflozin | 4 | 25 |
| Total, other adverse events | Placebo | 2 | 30 |
| Total, serious adverse events | Ertugliflozin | 10 | 25 |
| Total, serious adverse events | Placebo | 21 | 30 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ertugliflozin vs Placebo: Atleast One Hospitalization Due to Heart Failure | Trial comparisons |
| Ertugliflozin vs Placebo: Cardiovascular Mortality | Trial comparisons |
| Ertugliflozin vs Placebo: deaths from any cause | Trial comparisons |
| Ertugliflozin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04600921
GET https://conductscience.org/api/trials/v1/NCT04600921/events?page=2