Heart failure & cardiomyopathies

Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure: Results From SOLOIST-WHF

J Am Coll CardiolPublished Prespecified secondary analysis of the SOLOIST-WHF randomised trial

Primary result · Change in KCCQ-12Result — go to the resultAdjusted mean change 4.1 points 95% CI 1.3–7.0

Authors' conclusion

Sotagliflozin improved symptoms, physical limitations, and quality of life within 4 months after worsening HF, with consistent benefits across baseline demographic and clinical characteristics.

Study context

Population
Patients hospitalized or recently discharged after a worsening heart failure (HF) episode1,113 (91%) complete KCCQ-12 data
Participants
1,222 patients
Comparison
Sotagliflozin vs placebo
Primary endpoint
Total number of HF hospitalizations, urgent HF visits and CV death (trial primary endpoint); this analysis: change in KCCQ-12 score from baseline to month 4 (prespecified secondary endpoint)
Methodological detailsprespecified analyses
  • Prespecified analyses

Primary result

Change in KCCQ-12 · 4 months

Adjusted mean change

4.1 points

95% CI 1.3–7.0

P = 0.005

Sotagliflozinvs Placebo
adjusted mean change 4.1 points (95% CI 1.3–7.0); P = 0.005

As reported in the abstract

Secondary outcomes

OutcomeOR (95% CI)P value
At least small (≥5 points) improvement in KCCQ-12 · 4 months1.38 (1.06–1.80)P = 0.017

Trial primary endpoint (total HF hospitalizations, urgent HF visits and CV death) by KCCQ-12 tertile

Risk reduced consistently across KCCQ-12 tertiles
P for trend = 0.54

KCCQ-12 change by prespecified subgroups (incl. LVEF <50% or ≥50%)

Improvements consistent across prespecified subgroups

Baseline KCCQ-12 score (overall)

Median 41.7 (Q1-Q3: 27.1-58.3); improved by 4 months in both groups

Original publication

Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure: Results From SOLOIST-WHF. J Am Coll Cardiol. Published 17 September 2024. doi:10.1016/j.jacc.2024.06.036

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