European journal of heart failure · 2026
Dipstick proteinuria and outcomes in patients with heart failure and reduced ejection fraction: insights from GALACTIC-HF.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Ono Ryohei, Chimura Misato, Docherty Kieran F, Jhund Pardeep S, Yang Mingming, Henderson Alasdair D, Tolomeo Paolo, Metra Marco, Liu Genzhou, Divanji Punag H, Heitner Stephen B, Kupfer Stuart, Malik Fady I, Felker Gary Michael, Solomon Scott D, Teerlink John R, McMurray John J V
Аннотация
AIMS: Dipstick urine testing is often performed in primary and secondary care, although the results may not be routinely inspected or acted upon. We aimed to examine the prognostic value of semiquantitative urine dipstick proteinuria (DP) assessments in patients with heart failure (HF) and reduced ejection fraction.
METHODS: This retrospective analysis utilized data from GALACTIC-HF, a randomized trial that investigated the efficacy and safety of the cardiac myosin activator, omecamtiv mecarbil, compared with placebo in patients with HF with reduced ejection fraction. The primary outcome was the composite of a first HF event (hospitalization or urgent visit for HF) or cardiovascular death, and secondary outcomes were a HF event, cardiovascular death, and all-cause death. Cox proportional hazard models were used to examine the relationship between DP levels and clinical outcomes.
RESULTS: Baseline DP data were available for 7790 patients, of whom 5910 (75.9%) had a negative test or trace proteinuria, 995 (12.8%) had 1+, and 885 (11.4%) had ≥2+ proteinuria. The incidence rate of the primary outcome (per 100 person-years) increased significantly with increasing DP: negative/trace (21.8, 95% confidence interval 20.8-22.7); 1+ (34.8, 31.8-38.0); and ≥2+ (38.1, 34.7-41.9). Similar trends were observed for the components of the primary outcome and all-cause mortality. The association between greater DP and worse outcomes was stronger in patients with preserved (≥60 ml/min/1.73 m2) estimated glomerular filtration rate compared with reduced estimated glomerular filtration rate (<60 ml/min/1.73 m2).
CONCLUSION: In GALACTIC-HF, higher DP levels were independently associated with increased risk of adverse clinical outcomes in patients with reduced ejection fraction.
TRIAL REGISTRATION: GALACTIC-HF ClinicalTrials.gov Identifier: NCT02929329; EudraCT number, 2016-002299-28.
METHODS: This retrospective analysis utilized data from GALACTIC-HF, a randomized trial that investigated the efficacy and safety of the cardiac myosin activator, omecamtiv mecarbil, compared with placebo in patients with HF with reduced ejection fraction. The primary outcome was the composite of a first HF event (hospitalization or urgent visit for HF) or cardiovascular death, and secondary outcomes were a HF event, cardiovascular death, and all-cause death. Cox proportional hazard models were used to examine the relationship between DP levels and clinical outcomes.
RESULTS: Baseline DP data were available for 7790 patients, of whom 5910 (75.9%) had a negative test or trace proteinuria, 995 (12.8%) had 1+, and 885 (11.4%) had ≥2+ proteinuria. The incidence rate of the primary outcome (per 100 person-years) increased significantly with increasing DP: negative/trace (21.8, 95% confidence interval 20.8-22.7); 1+ (34.8, 31.8-38.0); and ≥2+ (38.1, 34.7-41.9). Similar trends were observed for the components of the primary outcome and all-cause mortality. The association between greater DP and worse outcomes was stronger in patients with preserved (≥60 ml/min/1.73 m2) estimated glomerular filtration rate compared with reduced estimated glomerular filtration rate (<60 ml/min/1.73 m2).
CONCLUSION: In GALACTIC-HF, higher DP levels were independently associated with increased risk of adverse clinical outcomes in patients with reduced ejection fraction.
TRIAL REGISTRATION: GALACTIC-HF ClinicalTrials.gov Identifier: NCT02929329; EudraCT number, 2016-002299-28.