CADENCE Study

A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF)

medical-cross
Heart failure, Pulmonary hypertension
user
All genders
person-wave 18-85
world
Recruiting now
More information  

Overview
Principal Investigator: Harrison Farber, MD

This study is designed to evaluate the safety and efficacy of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. 

Study details
Inclusion Criteria
  • Clinical diagnosis of HFpEF and demonstrated Cpc-PH through right heart catheterization
  • New York Heart Association FC of II or III
Exclusion Criteria
  • Diagnosis of WHO Group 1,3,4, or 5 Pulmonary Hypertension
  • Restrictive lung diseases such as COPD, diffuse interstitial fibrosis, or pulmonary thromboembolism
  • Certain cardiovascular conditions including atrial fibrillation, anticipated heart transplant or ventricular assist device implantation, heart attack within 90 days of first visit, history of more than mild mitral or aortic regurgitation or more than mild aortic or mitral stenosis
Study Requirements

Participants will receive subcutaneous injections of sotatarcept or placebo every 3 weeks for 24 weeks. Participants will be required to undergo a right heart catherization at screening and at 24 weeks, a total of 6 echocardiograms, 6 six minute walk tests, 9 electrocardiograms, and safety blood tests which will occur at each in-clinic visit. After the 24 week period, participants will enter an 18 month extension period where all participants will receive active study drug either at their previously assigned dose level if they were on drug previously or they will be randomized to receive either 0.3 or 0.7 mg/kg. An additional right heart catheterization will be obtained at Week 48.