Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure. (DELIVER)
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|ClinicalTrials.gov Identifier: NCT03619213|
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : May 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure With Preserved Ejection Fraction||Drug: Dapagliflozin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6100 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|
|Estimated Primary Completion Date :||June 22, 2021|
|Estimated Study Completion Date :||June 22, 2021|
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 33 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
- Total number of (first and recurrent) hospitalisations for HF and CV death [ Time Frame: up to approximately 33 months ]To determine whether dapagliflozin is superior to placebo in reducing the total number of recurrent HF hospitalisations and CV death
- 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
- Proportion of patients with worsened NYHA class from baseline to 8 months [ Time Frame: Evaluated at 8 months after randomization ]To determine whether dapagliflozin is superior to placebo in reducing the proportion of patients with worsened NYHA class
- Time to the occurrence of death from any cause [ Time Frame: up to approximately 33 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 33 months ]Safety: To evaluate the safety and tolerability of dapagliflozin compared to placebo in patients with HFpEF
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
|Contact: AstraZeneca Clinical Study Information Centeremail@example.com|