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Heart failure & cardiomyopathiesRandomised controlled trial

Sotatercept for Combined Post- and Precapillary Pulmonary Hypertension Associated With Heart Failure: Results From the Phase 2, Randomized, Placebo-Controlled CADENCE Study

CirculationPublished

  • Randomised controlled trial
  • multicentre
  • placebo-controlled
  • phase 2
Read the original article ↗

Authors' conclusion

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.

Study context

Population
Adults with combined post- and precapillary pulmonary hypertension in HFpEF
Participants
164 adults
Comparison
Sotatercept vs placebo
  • Sotatercept 0.3 mg/kgn = 54
  • Sotatercept 0.7 mg/kgn = 55
  • Placebon = 55reference
Primary endpoint
Change in pulmonary vascular resistance
Follow-up
Week 24

Primary result

As reported in the abstract

Change from baseline in pulmonary vascular resistance

Sotatercept 0.3 mg/kg

−0.67

median change · Wood units

Sotatercept 0.7 mg/kg

−0.33

median change · Wood units

Placebo

0.26

median change · Wood units

Sotatercept 0.3 mg/kg
Hodges-Lehmann shift estimate −1.02 Wood units (95% CI −1.81 to −0.23); P = 0.004
Sotatercept 0.7 mg/kg
Hodges-Lehmann shift estimate −0.75 Wood units (95% CI −1.52 to 0.03); P = 0.024

Further findings

Mean pulmonary arterial pressure (placebo-adjusted change) · week 24

0.3 mg/kg
−9.19 mm Hg (95% CI, −13.00 to −5.38)
0.7 mg/kg
−9.22 (95% CI, −12.97 to −5.46)
  • Hodges-Lehmann shift estimates

Pulmonary arterial wedge pressure (placebo-adjusted change) · week 24

0.3 mg/kg
−3.04 mm Hg (95% CI, −5.77 to −0.32)
0.7 mg/kg
−2.53 (95% CI, −5.33 to 0.28)
  • Hodges-Lehmann shift estimates

6-minute walk distance (placebo-adjusted change) · week 24

m

0.3 mg/kg
20.3 (95% CI, 1.5-39.1)
0.7 mg/kg
5.8 (95% CI, −17.3 to 28.9)
  • Hodges-Lehmann shift estimates

Safety

Adverse events

Most common AEs with sotatercept (both doses): increased hemoglobin and diarrhea

Original publication

Sotatercept for Combined Post- and Precapillary Pulmonary Hypertension Associated With Heart Failure: Results From the Phase 2, Randomized, Placebo-Controlled CADENCE Study. Circulation. Published 29 March 2026. doi:10.1161/circulationaha.126.079918
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Summarised from the published abstract; every number is checked against it