Trial · NCT03619213
Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.
NCT03619213, Phase 3, Completed, AstraZeneca; results first posted 2023-07-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure. Trials, record NCT03619213. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03619213
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.
- NCT number
- NCT03619213
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 6,263 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Interventions
- Dapagliflozin, Placebo
- First posted
- 2018-08-07
- Last updated
- 2023-07-11
- Other registries' IDs
- eudract:2018-000802-46
- Results first posted
- 2023-07-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. | Up to 42.1 months | Dual primary efficacy Primary endpoint analysed in all patients randomised (Full analysis set). The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date. |
| Primary | Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure for LVEF <60% Subpopulation | Up to 42.1 months | Dual primary efficacy Primary endpoint analysed in all patients randomised with LVEF \< 60% at baseline. The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date. |
| Secondary | Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) | Up to 42.1 months | Secondary efficacy Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients. The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date. |
| Secondary | Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) for LVEF <60% Subpopulation | Up to 42.1 months | Secondary efficacy Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients with LVEF \< 60% at baseline The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date. |
| Secondary | Change From Baseline in the KCCQ Total Symptom Score at 8 Months | Baseline and 8 months or death before 8 months | KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ Total Symptom Score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
| Secondary | Subjects Included in the Endpoint of Cardiovascular Death | Up to 42.1 months | Secondary efficacy The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date. |
| Secondary | Subjects Included in the Endpoint of All-cause Mortality | Up to 42.1 months | Secondary efficacy The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. | Up to 42.1 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure for LVEF <60% Subpopulation | Up to 42.1 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) | Up to 42.1 months | Full analysis set population | Number of events | NUMBER |
| SECONDARY | Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) for LVEF <60% Subpopulation | Up to 42.1 months | Full analysis set population | Number of events | NUMBER |
| SECONDARY | Change From Baseline in the KCCQ Total Symptom Score at 8 Months | Baseline and 8 months or death before 8 months | Full analysis set population, including only assessments performed or planned prior to March 11th, 2020, when COVID-19 was declared a pandemic by the WHO. | Scores on a scale | MEAN |
| SECONDARY | Subjects Included in the Endpoint of Cardiovascular Death | Up to 42.1 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Subjects Included in the Endpoint of All-cause Mortality | Up to 42.1 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. | Dapa 10 mg | 512 | Participants | ||
| Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. | Placebo | 610 | Participants | ||
| Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure for LVEF <60% Subpopulation | Dapa 10 mg | 381 | Participants | ||
| Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure for LVEF <60% Subpopulation | Placebo | 440 | Participants | ||
| Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) | Dapa 10 mg | 815 | Number of events | ||
| Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) | Placebo | 1057 | Number of events | ||
| Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) for LVEF <60% Subpopulation | Dapa 10 mg | 605 | Number of events | ||
| Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) for LVEF <60% Subpopulation | Placebo | 782 | Number of events | ||
| Change From Baseline in the KCCQ Total Symptom Score at 8 Months | Dapa 10 mg | 8.3 | Standard Deviation 20.3 | Scores on a scale | |
| Change From Baseline in the KCCQ Total Symptom Score at 8 Months | Placebo | 5.2 | Standard Deviation 21.1 | Scores on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dapa 10 mg | 3,131 | |
| Overall Study | STARTED | Placebo | 3,132 | |
| Overall Study | COMPLETED | Dapa 10 mg | 3,121 | |
| Overall Study | COMPLETED | Placebo | 3,121 | |
| Overall Study | NOT COMPLETED | Dapa 10 mg | 10 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
Adverse events1,816
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 | Atrial fibrillation | Cardiac disorders | Dapa 10 mg | 86 | 3,126 | 103 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 61 | 3,127 | 70 |
| other | Urinary tract infection | Infections and infestations | Dapa 10 mg | 113 | 3,126 | 142 |
| other | Urinary tract infection | Infections and infestations | Placebo | 112 | 3,127 | 128 |
| other | Cardiac failure | Cardiac disorders | Dapa 10 mg | 179 | 3,126 | 240 |
| other | Cardiac failure | Cardiac disorders | Placebo | 214 | 3,127 | 255 |
| other | Hypertension | Vascular disorders | Dapa 10 mg | 84 | 3,126 | 104 |
| other | Hypertension | Vascular disorders | Placebo | 102 | 3,127 | 136 |
| other | Hypotension | Vascular disorders | Dapa 10 mg | 69 | 3,126 | 80 |
| other | Hypotension | Vascular disorders | Placebo | 61 | 3,127 | 68 |
1 to 10 of 1,816Source ClinicalTrials.gov
See all 1,816 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dapa 10 mg | 510 | 3,131 |
| Total, all-cause mortality | Placebo | 533 | 3,132 |
| Total, other adverse events | Dapa 10 mg | 464 | 3,126 |
| Total, other adverse events | Placebo | 485 | 3,127 |
| Total, serious adverse events | Dapa 10 mg | 1,454 | 3,126 |
| Total, serious adverse events | Placebo | 1,508 | 3,127 |
Source ClinicalTrials.gov
Papers49
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dapa 10 mg vs Placebo: Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure for LVEF <60% Subpopulation | Trial comparisons |
| Dapa 10 mg vs Placebo: Subjects Included in the Endpoint of All-cause Mortality | Trial comparisons |
| Dapa 10 mg vs Placebo: Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. | Trial comparisons |
| Dapa 10 mg vs Placebo: deaths from any cause | Trial comparisons |
| Dapa 10 mg vs Placebo: Subjects Included in the Endpoint of Cardiovascular Death | Trial comparisons |
| Dapa 10 mg 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/NCT03619213
GET https://conductscience.org/api/trials/v1/NCT03619213/events?page=2