Table 2.
Study Name | Treatment Arms | Duration | Population | Primary Outcome |
---|---|---|---|---|
DETERMINE-reduced - Dapagliflozin Effect on Exercise Capacity Using a 6 min Walk Test in Patients With Heart Failure With Reduced Ejection Fraction; NCT0387723740 | Dapagliflozin, placebo | 16 weeks | 300 patients with HFrEF | Change from baseline in 6 min walking distance |
Effect of Dapagliflozin Plus Low Dose Pioglitazone on Hospitalization Rate in Patients With HF and HFpEF; NCT0379451841 | Dapagliflozin plus pioglitazone, placebo | 3 years | 648 patients with T2DM and HFpEF | Time to first hospitalization for heart failure after starting intervention |
Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure. (DELIVER); NCT0361921342 | Dapagliflozin, placebo | 33 months | 4700 patients with or without T2DM and HFpEF | Time to the first occurrence of any of the components of the composite outcome: CV death, hospitalization for HF, or urgent HF visit |
DETERMINE-preserved -Dapagliflozin Effect on Exercise Capacity Using a 6 min Walk Test in Patients With Heart Failure With Preserved Ejection Fraction; NCT0387722443 | Dapagliflozin, placebo | 16 weeks | 400 patients with HFpEF | Change from baseline in 6 min walking distance |
Dapagliflozin in PRESERVED Ejection Fraction Heart Failure (PRESERVED-HF); NCT0303023544 | Dapagliflozin, placebo | 12 weeks | 320 patients with HFpEF | Change from baseline in NTproBNP |
Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients; NCT0275139845 | Dapagliflozin, placebo | 24 weeks | 60 patients with T2DM and diastolic dysfunction | Subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography |
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease (Dapa-CKD); NCT0303615046 | Dapagliflozin, placebo | 4 years | 4000 patients with or without T2DM and CKD | Time to the first occurrence of any of the components of the composite outcome: ≥50% sustained decline in eGFR or reaching ESRD or CV death or renal death |
Abbreviations: CKD, chronic kidney disease; HF, heart failure; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; mo, months; NTproBNP, N-terminal pro b-type natriuretic peptide; T2DM, type 2 diabetes mellitus.