2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T4e6,Combined post- and pre-capillary pulmonary hypertension in heart failure with preserved ejection fraction (CpcPH-HFpEF) involves remodeling in both the heart and pulmonary vasculature. Despite significant mortality, there are no proven therapies. In this multicenter, randomized, placebo-controlled, phase 2 trial, adults received sotatercept (0.3 or 0.7 mg/kg) or placebo every 3 weeks. The primary end point was change in pulmonary vascular resistance at week 24. Hodges-Lehmann shift estimates described placebo-adjusted changes. 164 patients were randomized 54:55:55 to sotatercept 0.3 mg/kg, 0.7 mg/kg, and placebo, and baseline median pulmonary vascular resistance was 5.2 (interquartile range [IQR] 4.0-6.9) Wood units. The median change from baseline in pulmonary vascular resistance at week 24 was -0.67 Wood units in the sotatercept 0.3 mg/kg group, -0.33 Wood units in the sotatercept 0.7 mg/kg group, and 0.26 Wood units in the placebo group. The Hodges-Lehmann shift estimates in pulmonary vascular resistance were -1.02 Wood units (95% CI, -1.81 to -0.23; These findings provide proof of concept for improved pulmonary vascular and cardiac hemodynamics following activin signalling inhibition with sotatercept in patients with CpcPH-HFpEF.31:Tcc1, BACKGROUND: Combined post- and precapillary pulmonary hypertension in heart failure with preserved ejection fraction involves remodeling in both the heart and pulmonary vasculature. Despite significant mortality, there are no proven therapies. METHODS: In this multicenter, randomized, placebo-controlled, phase 2 trial, adults received sotatercept (0.3 or 0.7 mg/kg) or placebo every 3 weeks. The primary end point was change in pulmonary vascular resistance at week 24. Hodges-Lehmann shift estimates described placebo-adjusted changes. RESULTS: A total of 164 patients were randomized 54:55:55 to sotatercept 0.3 mg/kg, 0.7 mg/kg, and placebo, and baseline median pulmonary vascular resistance was 5.2 (interquartile range, 4.0–6.9) Wood units. The median change from baseline in pulmonary vascular resistance at week 24 was −0.67 Wood units in the sotatercept 0.3 mg/kg group, −0.33 Wood units in the sotatercept 0.7 mg/kg group, and 0.26 Wood units in the placebo group. The Hodges-Lehmann shift estimates in pulmonary vascular resistance were −1.02 Wood units (95% CI, −1.81 to −0.23; P =0.004) for 0.3 mg/kg and −0.75 Wood units (95% CI, −1.52 to 0.03; P =0.024) for 0.7 mg/kg sotatercept. Reductions were observed in mean pulmonary arterial pressure (0.3 and 0.7 mg/kg: −9.19 mm Hg [95% CI, −13.00 to −5.38] and −9.22 [95% CI, −12.97 to −5.46]) and pulmonary arterial wedge pressure (0.3 and 0.7 mg/kg: −3.04 mm Hg [95% CI, −5.77 to −0.32] and −2.53 [95% CI, −5.33 to 0.28]). Changes in 6-minute walk distance were 20.3 m (95% CI, 1.5–39.1) for 0.3 mg/kg and 5.8 m (95% CI, −17.3 to 28.9) for 0.7 mg/kg sotatercept. The most common adverse events with sotatercept (both groups) were increased hemoglobin and diarrhea. CONCLUSIONS: These findings provide proof of concept for improved pulmonary vascular and cardiac hemodynamics after activin signaling inhibition with sotatercept in patients with combined post- and precapillary pulmonary hypertension in heart failure with preserved ejection fraction. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04945460. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Combined Post- and Precapillary Pulmonary Hypertension: condition Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Combined Post- and Precapillary Pulmonary Hypertension (condition). 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The median change from baseline in pulmonary vascular resistance at week 24 was -0.67 Wood units in the sotatercept 0.3 mg/kg group, -0.33 Wood units in the sotatercept 0.7 mg/kg group, and 0.26 Wood units in the placebo group. 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Hypertension","value_numeric":null},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"condition","value":"Heart Failure With Preserved Ejection Fraction","value_numeric":null},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"generic","value":"sotatercept","value_numeric":null},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"modality","value":"Activin Signaling Inhibitor","value_numeric":null},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"sample_size","value":"n=164","value_numeric":164},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"warning","value":"Only a partial Hodges–Lehmann estimate was provided; dose-specific comparisons may be incomplete.","value_numeric":null},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"warning","value":"Safety outcomes and clinical endpoints beyond hemodynamics were not reported in the excerpt.","value_numeric":null},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"warning","value":"Sex distribution is not explicitly reported in the abstract; 'mixed' is inferred from typical trial enrollment practices.","value_numeric":null},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"warning","value":"The brand name 'Winrevair' is associated with sotatercept for PAH; its approval status specifically for CpcPH-HFpEF is not confirmed in this paper — clinicians should verify current labeling.","value_numeric":null},{"paper_doi":"10.1161/circulationaha.126.079918","tag_type":"warning","value":"The impact_flag 'practice_changing' is applied cautiously: while results are significant and novel, this is a phase 2 proof-of-concept trial without clinical outcome endpoints.","value_numeric":null}],"summaries":{"what_studied":"A multicenter, phase 2 randomized, placebo-controlled trial tested sotatercept 0.3 or 0.7 mg/kg every 3 weeks versus placebo in adults with combined post- and precapillary pulmonary hypertension associated with HFpEF. The primary end point was change in pulmonary vascular resistance (PVR) at 24 weeks; baseline median PVR was 5.2 Wood units (IQR 4.0–6.9).","key_result":"At week 24, median change in PVR was −0.67 Wood units with sotatercept 0.3 mg/kg, −0.33 with 0.7 mg/kg, and +0.26 with placebo. A Hodges–Lehmann shift estimate in PVR was −1.02 Wood units (95% CI, −1.81 to −0.23).","limitations":"Phase 2 study with modest sample size (n=164) and 24-week follow-up. The dose–response was non-linear, with the 0.3 mg/kg group showing a larger median PVR reduction than 0.7 mg/kg.","practice_takeaway":"Sotatercept lowered PVR versus placebo over 24 weeks in adults with CpcPH-HFpEF, supporting proof-of-concept for activin pathway inhibition. This is early-phase evidence and not practice-changing yet."}}],"initialOffset":1,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"condition","value":"Combined Post- and Precapillary Pulmonary Hypertension"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Conditions","href":"/hub/tag/condition"},{"name":"Combined Post- and Precapillary Pulmonary Hypertension"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"condition","hub_tag_value":"Combined Post- and Precapillary Pulmonary Hypertension"}}}]]

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