Pulmonary Hypertension: Sotatercept versus Placebo

Summary

This study focuses on individuals who have been diagnosed with a form of pulmonary hypertension (PH) associated with left heart disease, known as heart failure with preserved ejection fraction (HFpEF). PH is a disease affecting the blood vessels of the lungs, leading to increased pressure in the blood vessels of the lungs and straining of the right side of the heart. The purpose of the study is to determine whether an experimental treatment called sotatercept (given with participants’ current medications) is safe and can help slow the progression of PH caused by left heart disease, compared with current medications alone. Participants will be randomly assigned to receive sotatercept in one of 2 doses (0.3 mg/kg or 0.7 mg/kg) or placebo (inactive substance).


Inclusion Criteria

  • Participants must meet the following criteria to be enrolled in this proof-of-concept study:
  • Age 18 to 85 years
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

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

Details
Disease Type/Condition

Other

Principal Investigator

Hage, Antoine

Age Group

Adult

Phase

II

IRB Number

STUDY00001839

ClinicalTrials.gov ID

NCT04945460

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Hage, Antoine

Age Group

Adult

Phase

II

IRB Number

A011-16-CADENCE

ClinicalTrials.gov ID

NCT04945460

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?