Gerasimos Filippatos1, Aldo P Maggioni2, Carolyn S P Lam3, Elisabeth Pieske-Kraigher4, Javed Butler5, John Spertus6, Piotr Ponikowski7, Sanjiv J Shah8, Scott D Solomon9, Andrea-Viviana Scalise10, Katharina Mueller10, Lothar Roessig10, Luke Bamber10, Mihai Gheorghiade11, Burkert Pieske12. 1. National and Kapodistrian University of Athens, School of Medicine, Attikon University Hospital, Athens, Greece. 2. Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy. 3. National Heart Centre, Singapore and Duke-National University of Singapore, Singapore. 4. Charité Universitätsmedizin, Department of Internal Medicine and Cardiology, Charité University Medicine Berlin, Germany. 5. Division of Cardiology, Stony Brook University, Stony Brook, NY, USA. 6. Mid America Heart Institute of Saint Luke's Hospital, Kansas City, MO, USA. 7. Military Hospital of Wroclaw, Wroclaw, Poland. 8. Northwestern University, Chicago, IL, USA. 9. Brigham and Women's Hospital, Cardiovascular Division, Boston, MA, USA. 10. Bayer AG, Wuppertal, Germany. 11. Northwestern University Feinberg School of Medicine, Center for Cardiovascular Innovation, Chicago, IL, USA. 12. Department of Internal Medicine and Cardiology, Campus Virchow Klinikum; Charité University Medicine Berlin, and Department of Internal Medicine and Cardiology, German Heart Center Berlin, and DZHK (German Center for Cardiovascular Research), Berlin, Germany.
Abstract
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 ofvericiguat (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 withintravenous 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.
RCT Entities:
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.
Authors: Yogesh N V Reddy; Masaru Obokata; Katlyn E Koepp; Alexander C Egbe; Brandon Wiley; Barry A Borlaug Journal: Circ Res Date: 2019-01-18 Impact factor: 17.367
Authors: Chakradhari Inampudi; Daniel Silverman; Marc A Simon; Peter J Leary; Kavita Sharma; Brian A Houston; Jean-Luc Vachiéry; Francois Haddad; Ryan J Tedford Journal: Chest Date: 2021-08-12 Impact factor: 9.410