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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03619213
Recruitment Status : Completed
First Posted : August 7, 2018
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Ejection Fraction Drug: Dapagliflozin Drug: Placebo Phase 3

Detailed Description:
This is an international, multicentre, parallel-group, event-driven, randomised, double-blind study in patients with HFpEF, 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 and heart failure events (hospitalisations for HF or urgent HF visits). Adult patients aged ≥40 years with HFpEF (LVEF >40% and evidence of structural heart disease) and New York Heart Association (NYHA) class II-IV who are eligible according to the inclusion/exclusion criteria will be randomised in a 1:1 ratio to receive either dapagliflozin 10 mg or placebo. Both out-patients and in-patients hospitalised for heart failure and off intravenous heart failure-therapy for 24 hours can be randomised. It is estimated that approximately 11000 patients at approximately 400-500 sites in 20-25 countries will need to be enrolled to reach the target of approximately 6100 randomised patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: International, Double-blind, Randomised, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 27, 2018
Actual Primary Completion Date : March 27, 2022
Actual Study Completion Date : March 27, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Names:
  • Forxiga TM
  • Farxiga TM
Placebo Comparator: Placebo
Placebo matching dapagliflozin.
 Drug: Placebo
Placebo matching dapagliflozin 10 mg


Outcome Measures
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Primary Outcome Measures :
  1. Time to the first occurrence of any of the components of this composite: 1) CV death; 2) Hospitalisation for HF; 3) Urgent HF visit (e.g., emergency department or outpatient visit) [ Time Frame: Up to approximately 39 months ]

    To determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the composite of CV death and HF events (hospitalisation for HF or urgent HF visit) in patients with HF and preserved systolic function in

    • full study population
    • subpopulation with LVEF <60%


Secondary Outcome Measures :
  1. Total number of HF events (first and recurrent) and CV death [ Time Frame: up to approximately 39 months ]

    To determine whether dapagliflozin is superior to placebo in reducing the total number of HF events (hospitalisation for HF or urgent HF visit) and CV death in

    • full study population
    • subpopulation with LVEF <60%

  2. Change from baseline in the total symptom score (TSS) of the KCCQ at 8 months [ Time Frame: Evaluated at 8 months after randomization ]
    To determine whether dapagliflozin is superior to placebo in improving Patient Reported Outcomes measured by KCCQ

  3. Time to the occurrence of CV death [ Time Frame: up to approximately 39 months ]
    To determine whether dapagliflozin is superior to placebo in reducing CV death

  4. Time to the occurrence of death from any cause [ Time Frame: up to approximately 39 months ]
    To determine whether dapagliflozin is superior to placebo in reducing all-cause mortality


Other Outcome Measures:
  1. Serious adverse events (SAEs), adverse events leading to treatment discontinuation (DAEs), amputations, adverse events (AEs) leading to amputation and potential risk factor AEs for amputations affecting lower limbs [ Time Frame: up to approximately 39 months ]
    Safety: To evaluate the safety and tolerability of dapagliflozin compared to placebo in patients with HFpEF


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619213


Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03619213    
Other Study ID Numbers: D169CC00001
2018-000802-46 ( EudraCT Number )
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Dapagliflozin
 Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs