Trial · NCT03036124

Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure

NCT03036124, Phase 3, Completed, AstraZeneca; results first posted 2020-09-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure. Trials, record NCT03036124. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03036124

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure
NCT number: NCT03036124
Status: Completed
Phases: Phase 3
Enrollment: 4,744 participants, actual
Lead sponsor: AstraZeneca
Conditions: Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Interventions: Dapagliflozin, Placebo
First posted: 2017-01-30
Last updated: 2020-09-01
Other registries' IDs: eudract:2016-003897-41
Results first posted: 2020-09-01

Source ClinicalTrials.gov

Registered outcomes6

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 27.8 months.	Primary efficacy
Secondary	Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.	Up to 27.8 months.	Secondary
Secondary	Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.	Up to 27.8 months.	Secondary
Secondary	Change From Baseline in the KCCQ Total Symptom Score	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 Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.	Up to 27.8 months.	Secondary
Secondary	Subjects Included in the Endpoint of All-cause Mortality.	Up to 27.8 months.	Secondary

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	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 27.8 months.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.	Up to 27.8 months.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.	Up to 27.8 months.	events	NUMBER
SECONDARY	Change From Baseline in the KCCQ Total Symptom Score	Baseline and 8 months or death before 8 months	Scores on a scale	MEAN
SECONDARY	Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.	Up to 27.8 months.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Subjects Included in the Endpoint of All-cause Mortality.	Up to 27.8 months.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	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	386		Participants
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.	Placebo	502		Participants
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.	Dapa 10 mg	382		Participants
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.	Placebo	495		Participants
Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.	Dapa 10 mg	567		events
Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.	Placebo	742		events
Change From Baseline in the KCCQ Total Symptom Score	Dapa 10 mg	6.1	Standard Deviation 18.6	Scores on a scale
Change From Baseline in the KCCQ Total Symptom Score	Placebo	3.3	Standard Deviation 19.2	Scores on a scale
Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.	Dapa 10 mg	28		Participants
Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.	Placebo	39		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dapa 10mg	2,373
Overall Study	STARTED	Placebo	2,371
Overall Study	COMPLETED	Dapa 10mg	2,368
Overall Study	COMPLETED	Placebo	2,365
Overall Study	NOT COMPLETED	Dapa 10mg	5
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events1,258

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 10mg	58	2,368	63
other	Atrial fibrillation	Cardiac disorders	Placebo	52	2,368	55
other	Cardiac failure	Cardiac disorders	Dapa 10mg	76	2,368	90
other	Cardiac failure	Cardiac disorders	Placebo	130	2,368	154
other	Nasopharyngitis	Infections and infestations	Dapa 10mg	63	2,368	84
other	Nasopharyngitis	Infections and infestations	Placebo	76	2,368	100
other	Renal impairment	Renal and urinary disorders	Dapa 10mg	63	2,368	67
other	Renal impairment	Renal and urinary disorders	Placebo	56	2,368	60
other	Hypotension	Vascular disorders	Dapa 10mg	88	2,368	98
other	Hypotension	Vascular disorders	Placebo	73	2,368	81

1 to 10 of 1,258Source ClinicalTrials.gov

See all 1,258 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dapa 10mg	286	2,368
Total, all-cause mortality	Placebo	333	2,368
Total, other adverse events	Dapa 10mg	299	2,368
Total, other adverse events	Placebo	325	2,368
Total, serious adverse events	Dapa 10mg	895	2,368
Total, serious adverse events	Placebo	994	2,368

Source ClinicalTrials.gov

Papers52

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31081589	DERIVED	PubMed
31309699	DERIVED	PubMed
31535829	DERIVED	PubMed
31736328	DERIVED	PubMed
31736335	DERIVED	PubMed
32219386	DERIVED	PubMed
32539224	DERIVED	PubMed
32653447	DERIVED	PubMed
32673497	DERIVED	PubMed
32820334	DERIVED	PubMed

1 to 10 of 52

See all 52 papers

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 ≥50% Sustained Decline in eGFR, ESRD or Renal Death.	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 or Hospitalization Due to Heart Failure.	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 10mg vs Placebo: deaths from any cause	Trial comparisons
Dapa 10mg 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03036124

GET https://conductscience.org/api/trials/v1/NCT03036124/events?page=2

API reference For AI assistants