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NCT07839585
A Clinical Study of Sotatercept (MK-7962) in People With Combined Postcapillary and Precapillary Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (MK-7962-041)
Conditions: Pulmonary Hypertension
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 352
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for other ways to treat people with combined postcapillary and precapillary pulmonary hypertension (CpcPH). This trial focuses on CpcPH that is related to heart failure with preserved ejection fraction (HFpEF). The goal of the study is to learn if participants who receive sotatercept live longer without their CpcPH-HFpEF getting worse than those who receive placebo.
Eligibility Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has clinical diagnosis of HF with preserved ejection fraction on optimized guideline-directed medical therapy
* Has CpcPH confirmed by right-heart catheterization
* Has NYHA FC II or III
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has a diagnosis of PH in World Health Organization Group 1, 3, 4, or 5
* Has CV comorbidities:
* History of surgical or transcatheter correction of mitral or aortic stenosis or regurgitation within 12 months before Screening
* More than one valve replacement or repair (mechanical or bioprosthetic), or anticipated valve replacement or repair during the study
* History of serious, life-threatening, or hemodynamically significant arrhythmia, long corrected QT interval syndrome, or Brugada syndrome
* History of hypertrophic cardiomyopathy, infiltrative cardiomyopathy (including, but not limited to, cardiac amyloidosis), dilated cardiomyopathy, arrhythmogenic ventricular cardiomyopathy, or restrictive cardiomyopathy
* History or evidence of chronic liver disease
* Has a current diagnosis of end-stage renal disease
* History of organ transplantation (except corneal transplant) or bone marrow transplantation ≤5 years before Screening or has a life expectancy of \
Source: ClinicalTrials.gov (NCT07839585). StuddyBuddy aggregates publicly available trial information.