Dapagliflozin Evaluation to Improve the LIVEs of Patients with PReserved Ejection Fraction Heart Failure. - DELIVER

Study identifier:D169CC00001

ClinicalTrials.gov identifier:NCT03619213

EudraCT identifier:2018-000802-46

CTIS identifier:N/A

Study Complete

Official Title

An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients with Heart Failure with Preserved Ejection Fraction (HFpEF)

Medical condition

Heart Failure with preserved Ejection Fraction

Phase

Phase 3

Healthy volunteers

Study drug

Dapagliflozin, Placebo

Sex

All

Actual Enrollment

6263

Study type

Interventional

Age

40 Years - 130 Years

Date

Study Start Date: 27 Aug 2018

Primary Completion Date: 27 Mar 2022

Study Completion Date: 27 Mar 2022

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Provision of signed informed consent prior to any study specific procedures.
2. Male or female patients age ≥40 years.
3. 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.
4. 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.
5. Elevated NT-pro BNP levels.
6. 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

1. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
2. Type 1 diabetes mellitus (T1D).
3. eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.
4. Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
5. Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
6. MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.
7. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
8. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
9. Probable alternative or concomitant diagnoses which in the opinion of the investigator could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism).
10. Body mass index >50 kg/m2.
Further exclusion criteria may apply

No locations available

Arms	Assigned Interventions
Experimental: Dapagliflozin Patients will be randomized 1:1 to either dapagliflozin or placebo.	Drug: Dapagliflozin 10 mg tablets given once daily, per oral use. Other Name: Forxiga TM Other Name: Farxiga TM
Placebo Comparator: Placebo Placebo matching dapagliflozin.	Drug: Placebo Placebo matching dapagliflozin 10 mg

Documents available

Redacted Clinical Study Protocol
Download
Redacted Statistical Analysis Plan
Download
Redacted CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]