Phase 3 N=6,263 Randomized Quadruple-blind Treatment

Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.

Heart Failure With Preserved Ejection Fraction

Bottom Line

View on ClinicalTrials.gov: NCT03619213 ↗

Enrolled (actual)

6,263

Serious AEs

47.4%

Results posted

Jul 2023

Primary outcome: Primary: Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. — 512; 610 Participants — p=0.0008

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dapagliflozin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.	512; 610	0.0008 sig
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	381; 440	0.0085 sig
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)	815; 1057	0.0003 sig
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	605; 782	0.0017 sig
SECONDARY Change From Baseline in the KCCQ Total Symptom Score at 8 Months	8.3; 5.2	0.0086 sig
SECONDARY Subjects Included in the Endpoint of Cardiovascular Death	231; 261	0.1678
SECONDARY Subjects Included in the Endpoint of All-cause Mortality	497; 526	0.3425

Summary

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.

Eligibility Criteria

Inclusion Criteria

Provision of signed informed consent prior to any study specific procedures.
Male or female patients age ≥40 years.
Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.
Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.
Elevated NT-pro BNP levels.
Both ambulatory and hospitalised patients may be enrolled and randomised. Patients currently hospitalised for HF, must be off intravenous HF medications for at least 24 before randomisation.

Further details regarding inclusion criteria 4-6 may apply.

Exclusion Criteria

Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
Type 1 diabetes mellitus (T1D).
eGFR 50 kg/m2.

Further exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03619213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.