Heart failure & cardiomyopathiesRandomised controlled trial
Effect of Dapagliflozin Versus Placebo on Symptoms and 6-Minute Walk Distance in Patients With Heart Failure: The DETERMINE Randomized Clinical Trials
- Randomised controlled trial
- double-blind
- placebo-controlled
- multicentre
- two trials (DETERMINE-Reduced, DETERMINE-Preserved)
Authors' conclusion
Dapagliflozin improved the KCCQ-TSS in patients with HF with reduced ejection fraction but did not improve KCCQ-PLS or 6MWD. Dapagliflozin did not improve these outcomes in patients with HF with preserved ejection fraction. In a post hoc analysis including all patients across the full spectrum of ejection fraction, there was a beneficial effect of dapagliflozin on KCCQ-TSS and KCCQ-PLS but not 6MWD.
Study context
- Population
- Heart failure (HF) (HFrEF: DETERMINE-Reduced; HFpEF: DETERMINE-Preserved) with NYHA class II or III symptoms and elevated natriuretic peptide levels313 HFrEF
- Comparison
- Dapagliflozin vs placebo
- Primary endpoint
- Changes in KCCQ-TSS, KCCQ-PLS and 6MWD
- Follow-up
- 16 weeks
Primary result
As reported in the abstract
Change from baseline in KCCQ-TSS, KCCQ-PLS and 6MWD
Dapagliflozin vs PlaceboMedian placebo-corrected differenceP value
DETERMINE-Reduced (HFrEF): KCCQ-TSS
4.2(95% CI 1.0–8.2)
P = 0.022DETERMINE-Reduced (HFrEF): KCCQ-PLS
4.2(95% CI 0.0–8.3)
P = 0.058DETERMINE-Preserved (HFpEF): KCCQ-TSS
3.2(95% CI 0.4–6.0)
P = 0.079DETERMINE-Preserved (HFpEF): KCCQ-PLS
3.1(CI −0.1 to 5.4)
P = 0.23Dapagliflozin vs PlaceboMedian placebo-corrected difference, meters (95% CI)P value
DETERMINE-Reduced (HFrEF): 6MWD
3.2(−6.5 to 13.0)
P = 0.69- DETERMINE-Preserved (HFpEF): median 16-week difference in 6MWD
- 1.6 meters (95% CI, −5.9, 9.0; P=0.67)
Further findings
| Outcome | median placebo-corrected difference (CI) | P value | |
|---|---|---|---|
| DETERMINE-Pooled (exploratory post hoc analysis of both trials) · 16 weeks — Dapagliflozin vs Placebo · KCCQ-TSS · exploratory post hoc analysis | 3.7 (1.5–5.9) | P = 0.005 | |
| DETERMINE-Pooled (exploratory post hoc analysis of both trials) · 16 weeks — Dapagliflozin vs Placebo · KCCQ-PLS · exploratory post hoc analysis | 4.0 (0.3–4.9) | P = 0.036 | |
| −50510Difference (linear scale) |
| Outcome | median placebo-corrected difference (meters) (CI) | P value | |
|---|---|---|---|
| DETERMINE-Pooled (exploratory post hoc analysis of both trials) · 16 weeks — Dapagliflozin vs Placebo · 6MWD · exploratory post hoc analysis | 2.5 (−3.5 to 8.4) | P = 0.50 | |
| −50510Difference, meters (linear scale) |
Original publication
Effect of Dapagliflozin Versus Placebo on Symptoms and 6-Minute Walk Distance in Patients With Heart Failure: The DETERMINE Randomized Clinical Trials. Circulation. Published 7 December 2023. doi:10.1161/circulationaha.123.065061
Summarised from the published abstract; every number is checked against it