Trial reportEuropean heart journal. Cardiovascular pharmacotherapy2025
Sacubitril/valsartan and quality of life assessed using the EuroQol Five-dimension Three-level questionnaire level sum score (EQ-5D-3L-LSS) in patients with HFrEF and HFmrEF/HFpEF.
Trial report in European heart journal. Cardiovascular pharmacotherapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction (PARAGON-HF)
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19 authors.
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Abstract
aimsTo investigate the EQ-5D-3L Level Sum Score (LSS) in patients with heart failure (HF) and reduced (HFrEF) and mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) and the effect of sacubitril/valsartan on this score using patient-level data from the PARADIGM-HF and PARAGON-HF trials. METHODS AND
resultsThe LSS was calculated by summing the three levels (1-3) for each of the five domains (minimum sum score = 5; maximum sum score = 15). Patient characteristics and outcomes were compared across LSS tertiles (T1-T3) at baseline. Cox models were used to evaluate the primary endpoint [first HF hospitalization or cardiovascular death (CVD)] according to tertiles of LSS. Changes in LSS severity at 8 months were analysed using ordinal logistic regression models to estimate the effect of sacubitril/valsartan vs. enalapril or valsartan. Of 13 195 patients, 12 974 had a baseline LSS. Compared to lower LSS, patients with higher (worse) scores were older, more often women and White, and had more comorbidities and more severe HF. At 8 months, patients assigned to sacubitril/valsartan experienced more improvement and less worsening of LSS vs. the comparator: OR:1.16 (95%CI: 1.08-1.24). Sacubitril/valsartan also reduced the risk of the primary outcome across LSS tertiles: T1: HR: 0.87 (95%CI: 0.75-1.00); T2: 0.80 (95%CI: 0.71-0.90); T3: 0.87 (95%CI: 0.77-0.97); Pinteraction = 0.59. Higher LSS was independently associated with a greater risk of the primary endpoint, and the achieved LSS at 8 months may be more strongly associated with subsequent outcomes.
conclusionSacubitril/valsartan significantly reduced the risk of HF events and improved health status across the LSS spectrum in HFrEF and HFmrEF/HFpEF. CLINICAL
trial registrationhttps://www.clinicaltrials.gov. Unique identifiers: NCT01920711 (PARAGON-HF), NCT01035255 (PARADIGM-HF).
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