Heart failure & cardiomyopathies
Sotatercept for Combined Post- and Precapillary Pulmonary Hypertension Associated With Heart Failure: Results From the Phase 2, Randomized, Placebo-Controlled CADENCE Study
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
Methodological detailsmulticentre, placebo-controlled, phase 2
- Multicentre
- Placebo-controlled
- Phase 2
Primary result
As reported in the abstract
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
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
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