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
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|Condition or disease||Intervention/treatment||Phase|
|Heart Failure With Preserved Ejection Fraction||Drug: Dapagliflozin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6263 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||International, Double-blind, Randomised, Placebo-Controlled|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Patients will be randomized 1:1 to either dapagliflozin or placebo.
10 mg tablets given once daily, per oral use.
Placebo Comparator: Placebo
Placebo matching dapagliflozin.
Placebo matching dapagliflozin 10 mg
- 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%
- 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%
- 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
- 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
- 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
- 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
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.
|Ages Eligible for Study:||40 Years to 130 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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 <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.
- Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
- 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.
- 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.
- Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
- Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
- 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).
- Body mass index >50 kg/m2.
Further exclusion criteria may apply
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
|Other Study ID Numbers:||
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.|
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|
|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|
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