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Patient‐reported outcomes in the SOluble guanylate Cyclase stimulatoR in heArT failurE patientS with PRESERVED ejection fraction ( SOCRATES‐PRESERVED ) study
Author(s) -
Filippatos Gerasimos,
Maggioni Aldo P.,
Lam Carolyn S.P.,
PieskeKraigher Elisabeth,
Butler Javed,
Spertus John,
Ponikowski Piotr,
Shah Sanjiv J.,
Solomon Scott D.,
Scalise AndreaViviana,
Mueller Katharina,
Roessig Lothar,
Bamber Luke,
Gheorghiade Mihai,
Pieske Burkert
Publication year - 2017
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1002/ejhf.800
Subject(s) - medicine , ejection fraction , heart failure , placebo , decompensation , randomized controlled trial , cardiology , minimal clinically important difference , pathology , alternative medicine
Aims Exploratory assessment of the potential benefits of the novel soluble guanylate cyclase stimulator vericiguat on health status in patients with heart failure ( HF ) with preserved ejection fraction. Methods and results The SOCRATES‐PRESERVED trial randomized patients with chronic HF and ejection fraction ≥ 45% within 4 weeks of decompensation to 12 weeks of treatment with titrated doses of vericiguat (1.25, 2.5, 5, and 10 mg once daily) or placebo. Health status was assessed with the disease‐specific Kansas City Cardiomyopathy Questionnaire ( KCCQ ) and the generic health‐related quality of life measure EQ‐5D . In total, 477 patients were randomized 12.9 ± 9.0 days after hospitalization or if requiring outpatient treatment with intravenous diuretics for HF . Baseline KCCQ clinical summary score ( CSS ), a combination of symptom and physical function domains, was 52.3 ± 20.4 in the 10 mg arm and 54.1 ± 23.0 in placebo, and EQ‐5D US index score was 0.74 ± 0.2 and 0.73 ± 0.2, respectively. A larger proportion of patients treated with vericiguat in the 10 mg arm, compared with placebo, achieved clinically meaningful improvements in KCCQ‐CSS (82.0% vs. 59.0%, number needed to treat = 4.35, P = 0.0052). Important domains of the KCCQ as well as EQ‐5D scores demonstrated a dose‐dependent relationship with vericiguat. In the 10 mg arm, the mean physical limitations domain increased by +17.2 ± 19.1 at 12 weeks, compared with +4.5 ± 21.6 in placebo ( P = 0.0009). The EQ‐5D US index score increased by +0.064 ± 0.167 in the 10 mg arm, compared with a decrease of −0.009 ± 0.195 in placebo ( P = 0.0461). Improvements in KCCQ and EQ‐5D scores paralleled physician‐assessed NYHA class and clinical congestion. Conclusion Vericiguat, in exploratory hypothesis‐generating analyses, was associated with clinically important improvements in patients' health status, as assessed by the KCCQ and EQ‐5D . Further studies should be conducted to test the hypothesis that vericiguat improves physical functioning and health‐related quality of life in patients with HF with preserved ejection fraction.