DAPA-HF | ACROSS T2D

DAPA-HF

The DAPA-HF trial assessed the efficacy and safety of dapagliflozin in patients with heart failure and a reduced ejection fraction, with or without diabetes. This module details the results.

DAPA-HF

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references
1. McMurray J et al. Eur J Heart Fail 2019;21:665
2. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. Eur J Heart Fail 2019;21:665
2. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. Eur J Heart Fail 2019;21:665
2. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
2. Petrie MC et al. JAMA 2020; doi:10.1001/jama.2020.1906
1. Docherty KF et al. Eur Heart J 2020; doi:10.1093/eurheartj/ehaa183
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
1. McMurray J et al. N Engl J Med 2019;381:1995
notes
Abbreviations
CV, cardiovascular; eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; HF, heart failure; HHF hospitalisation for heart failure; KCCQ, Kansas City Cardiomyopathy Questionnaire; SGLT2, sodium-glucose co-transporter-2

Recent worsening HF or other cardiovascular events or procedures (or planned procedures) include:
- Current acute decompensated HF or hospitalisation due to decompensated HF <4 weeks prior to enrolment
- Myocardial infarction, unstable angina, stroke or transient ischaemic attack within 12 weeks prior to enrolment
- Coronary revascularisation or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomisation
- Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
- HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or uncorrected primary valvular disease
Abbreviations
CRT, cardiac resynchronisation therapy; CV, cardiovascular; HF, heart failure
Reference
McMurray J et al. Eur J Heart Fail 2019;21:665

Exploratory outcomes:
-  Expanded composite worsening HF event (CV death, HHF, urgent HF visit, documented evidence of worsening HF symptoms/signs leading to initiation of a new treatment for HF sustained for ≥4 weeks or augmentation of existing oral therapy for HF sustained for ≥4 weeks)
-  Change in NYHA class from baseline
-  Proportion of patients without a history of AF at baseline with a new diagnosis of AF during the study
-  Time to the first occurrence of each of any of the following central lab levels of serum potassium:
•  >6.0 mmol/l
•  >5.5 mmol/l
•  <3.5 mmol/l
•  <3.0 mmol/l
-  Number of events with doubling of serum creatinine
Abbreviations
AF, atrial fibrillation; CV, cardiovascular; HF, heart failure; HHF, hospitalisation for heart failure; NYHA, New York Heart Association
Reference
McMurray J et al. Eur J Heart Fail 2019; doi: 10.1002/ejhf.1548
- Testing will continue down the hierarchy if superiority for the preceding endpoint is demonstrated at a two‑sided α=0.0499 level, and will stop if superiority is not achieved. The superiority for the composite worsening kidney function outcome was not achieved (HR 0.71, 95% CI 0.44 to 1.16); therefore, in the statistical testing hierarchy, the all-cause mortality endpoint should be considered exploratory.
- Data may not add up to 100% due to rounding
- Patients in NYHA functional class III or IV appeared to have less benefit than those in class II, although the p-value for interaction was not reported
Abbreviation
NYHA, New York Heart Association
Reference
McMurray J et al. N Engl J Med 2019; doi: 10.1056/NEJMoa1911303
- Outcomes with dapagliflozin were also consistent regardless of combination of therapy
Reference
Docherty KF et al. Eur Heart J 2020;doi: 10.1093/eurheartj/ehaa183
Related links

DAPA-HF
DAPA-HF
DAPA-HF
DAPA-HF: trial design^1,2
DAPA-HF: key inclusion and exclusion criteria^1,2
DAPA-HF: hierarchical analysis plan^1,2
DAPA-HF: hypothesis testing outcomes and subsequent analysis^1,2
DAPA-HF: baseline characteristics (1/2)
DAPA-HF: baseline characteristics (2/2)
DAPA-HF: baseline medication
DAPA-HF
DAPA-HF: primary composite outcome of worsening HF^* or CV death (1/2)
DAPA-HF: primary composite outcome of worsening HF^* or CV death (2/2)
DAPA-HF: CV death
DAPA-HF: hospitalisation for heart failure
DAPA-HF: primary composite outcome^* by prespecified subgroups (1/3)
DAPA-HF: primary composite outcome^* by prespecified subgroups (2/3)
DAPA-HF: primary composite outcome^* by prespecified subgroups (3/3)
DAPA-HF: primary composite outcome^* in patients with or without T2D at baseline
DAPA-HF
DAPA-HF: secondary efficacy outcomes
DAPA-HF: all-cause mortality
DAPA-HF: secondary outcome of change in KCCQ total symptom score
DAPA-HF
In DAPA-HF, the effect of dapagliflozin on CV and HHF outcomes was generally consistent between patients with or without T2D at baseline
Effects of dapagliflozin in CV death and HHF were consistent regardless of background therapy and dose in DAPA-HF
DAPA-HF
DAPA-HF: metabolic parameters
DAPA-HF
DAPA-HF: safety summary
DAPA-HF
DAPA-HF: summary^1,2
DAPA-HF: patient population