The Phase 2 CADENCE randomised controlled trial tested sotatercept in patients with combined post- and pre-capillary pulmonary hypertension in heart failure with preserved ejection fraction (CpcPH-HFpEF) — a serious condition with high mortality and no proven treatments (Group 2 WHO pulmonary hypertension classification).
164 patients received either sotatercept (at one of two doses) or placebo every three weeks for 24 weeks. Both doses significantly reduced pulmonary vascular resistance compared to placebo, with additional improvements in mean pulmonary arterial pressure and pulmonary arterial wedge pressure. The lower dose (0.3 mg/kg) also showed a meaningful improvement in six-minute walk distance. The most common side effects were increased haemoglobin and diarrhoea.
The authors conclude that sotatercept shows promising proof-of-concept results for improving pulmonary vascular and cardiac haemodynamics in this patient population, supporting further investigation.
Read more at this link on Circulation
Citation
Gomberg-Maitland M, Tedford RJ, Langleben D, Rosenkranz S, Miller B, Jones AD, Urbinati A, McMullan CJ, Cornell AG, Vachiery JL. Sotatercept for Combined Post- and Pre-capillary Pulmonary Hypertension Associated With Heart Failure: Results from the Phase 2, Randomized, Placebo-Controlled CADENCE Study. Circulation. 2026 Mar 29. doi: 10.1161/CIRCULATIONAHA.126.079918. Epub ahead of print. PMID: 41904795.