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• W3093011007 abstract "<h3>Importance</h3> Heart failure with preserved ejection fraction (HFpEF) is often characterized by nitric oxide deficiency. <h3>Objective</h3> To evaluate the efficacy and adverse effects of praliciguat, an oral soluble guanylate cyclase stimulator, in patients with HFpEF. <h3>Design, Setting, and Participants</h3> CAPACITY HFpEF was a randomized, double-blind, placebo-controlled, phase 2 trial. Fifty-nine sites enrolled 196 patients with heart failure and an ejection fraction of at least 40%, impaired peak rate of oxygen consumption (peak V̇o₂), and at least 2 conditions associated with nitric oxide deficiency (diabetes, hypertension, obesity, or advanced age). The trial randomized patients to 1 of 3 praliciguat dose groups or a placebo group, but was refocused early to a comparison of the 40-mg praliciguat dose vs placebo. Participants were enrolled from November 15, 2017, to April 30, 2019, with final follow-up on August 19, 2019. <h3>Interventions</h3> Patients were randomized to receive 12 weeks of treatment with 40 mg of praliciguat daily (n = 91) or placebo (n = 90). <h3>Main Outcomes and Measures</h3> The primary efficacy end point was the change from baseline in peak V̇o₂in patients who completed at least 8 weeks of assigned dosing. Secondary end points included the change from baseline in 6-minute walk test distance and in ventilatory efficiency (ventilation/carbon dioxide production slope). The primary adverse event end point was the incidence of treatment-emergent adverse events (TEAEs). <h3>Results</h3> Among 181 patients (mean [SD] age, 70 [9] years; 75 [41%] women), 155 (86%) completed the trial. In the placebo (n = 78) and praliciguat (n = 65) groups, changes in peak V̇o₂were 0.04 mL/kg/min (95% CI, –0.49 to 0.56) and −0.26 mL/kg/min (95% CI, −0.83 to 0.31), respectively; the placebo-adjusted least-squares between-group difference in mean change from baseline was −0.30 mL/kg/min ([95% CI, −0.95 to 0.35];<i>P</i> = .37). None of the 3 prespecified secondary end points were statistically significant. In the placebo and praliciguat groups, changes in 6-minute walk test distance were 58.1 m (95% CI, 26.1-90.1) and 41.4 m (95% CI, 8.2-74.5), respectively; the placebo-adjusted least-squares between-group difference in mean change from baseline was –16.7 m (95% CI, −47.4 to 13.9). In the placebo and praliciguat groups, the placebo-adjusted least-squares between-group difference in mean change in ventilation/carbon dioxide production slope was −0.3 (95% CI, −1.6 to 1.0). There were more dizziness (9.9% vs 1.1%), hypotension (8.8% vs 0%), and headache (11% vs 6.7%) TEAEs with praliciguat compared with placebo. The frequency of serious TEAEs was similar between the groups (10% in the praliciguat group and 11% in the placebo group). <h3>Conclusions and Relevance</h3> Among patients with HFpEF, the soluble guanylate cyclase stimulator praliciguat, compared with placebo, did not significantly improve peak V̇o₂from baseline to week 12. These findings do not support the use of praliciguat in patients with HFpEF. <h3>Trial Registration</h3> ClinicalTrials.gov Identifier:NCT03254485" @default.
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• W3093011007 date "2020-10-20" @default.
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• W3093011007 title "Effect of Praliciguat on Peak Rate of Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction" @default.
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• W3093011007 doi "https://doi.org/10.1001/jama.2020.16641" @default.
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