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) (CHORUS)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sotatercept in Adults With Combined Postcapillary and Precapillary Pulmonary Hypertension (CpcPH) and Heart Failure With Preserved Ejection Fraction (HFpEF)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Participants will have the option to continue or start treatment with sotatercept in the extension study, MK-7962-023 (NCT06814145), after completing the End of Treatment visit.
Studietype
Registrering (Antatt)
Fase
- Fase 3
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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 <12 months
-
History of malignancy ≤5 years before Screening, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in situ, or ≤2 squamous cell carcinomas of the skin
-
Has any noncardiopulmonary condition or acute/chronic impairment(s) (other than dyspnea) that limits their ability to perform the 6-minute walk test
-
Has moderate or severe obstructive sleep apnea
-
Has a body mass index ≥50 kg/m^2
-
Has been treated with any approved pulmonary arterial hypertension-specific medications within 30 days of Randomization
-
Has background medication with the following agents: sodium-glucose cotransporter-2 inhibitor, renin-angiotensin-aldosterone system inhibitors, mineralocorticoid receptor antagonists, diuretics, and beta-blockers, that is not a stable dose for ≥30 days before Randomization
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Sotatercept
Participants will receive sotatercept 0.3 mg/kg via subcutaneous (SC) injection every 3 weeks until end of study (up to approximately 37 months). |
SC injection administered every 3 weeks.
Andre navn:
|
|
Placebo komparator: Placebo
Participants will receive matching placebo via SC injection every 3 weeks until end of study (up to approximately 37 months). |
SC injection administered every 3 weeks. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Clinical Worsening (TTCW)
Tidsramme: Up to ~37 months
|
TTCW was defined as time to first occurrence of any of the following events: cardiovascular (CV) death, hospitalization due to worsening heart failure (HF) or pulmonary hypertension (PH), urgent visits due to worsening HF or PH, or deterioration in exercise capacity (≥15% decrease from baseline in 6-minute walk distance [6MWD], confirmed by 2 tests) due to worsening HF or PH. CV deaths are defined as any deaths with a primary CV cause, including acute myocardial infarction (MI), sudden cardiac death, HF, PH worsening, stroke, and other CV causes. |
Up to ~37 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to First Event of CV Death, Hospitalization Due to Worsening HF or PH, or Urgent Visit Due to Worsening HF or PH
Tidsramme: Up to ~37 months
|
CV deaths are defined as any deaths with a primary CV cause, including acute MI, sudden cardiac death, HF, PH worsening, stroke, and other CV causes. The time to first event of CV death, hospitalization due to worsening HF or PH, or urgent visit due to worsening HF or PH will be presented. |
Up to ~37 months
|
|
Time to First Event of CV Death or Hospitalization Due to Worsening HF or PH
Tidsramme: Up to ~37 months
|
CV deaths are defined as any deaths with a primary CV cause, including acute MI, sudden cardiac death, HF, PH worsening, stroke, and other CV causes. The time to first event of CV death or hospitalization due to worsening HF or PH will be presented. |
Up to ~37 months
|
|
Change From Baseline in 6MWD at Week 24
Tidsramme: Baseline and Week 24
|
The 6MWD tests the distance walked in 6 minutes as an assessment of exercise capacity. The baseline value for 6MWD is the average of the 2 values collected during Screening. The change from baseline in 6MWD at Week 24 will be presented. |
Baseline and Week 24
|
|
Time to the Date of Death Due to Any Cause
Tidsramme: Up to ~37 months
|
The time to date of death (all causes) will be presented. |
Up to ~37 months
|
|
Time to First Hospitalization Due to Worsening HF or PH
Tidsramme: Up to ~37 months
|
The time to first hospitalization due to worsening HF or PH will be presented. |
Up to ~37 months
|
|
Time to First Urgent Visit Due to Worsening HF or PH
Tidsramme: Up to ~37 months
|
The time to first urgent visit due to worsening HF or PH will be presented. |
Up to ~37 months
|
|
Percentage of Participants Maintaining and/or Improving New York Heart Association (NYHA) Functional Class (FC) at Week 24
Tidsramme: Week 24
|
NYHA FC classifies the extent of heart failure. The percentage of participants maintaining and/or improving NYHA FC at Week 24 will be presented. |
Week 24
|
|
Change From Baseline in N-Terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Levels at Week 24
Tidsramme: Baseline and Week 24
|
NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP levels at Week 24 will be presented. |
Baseline and Week 24
|
|
Number of Participants Who Experience One or More Adverse Events (AEs)
Tidsramme: Up to ~37 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented. |
Up to ~37 months
|
|
Number of Participants Who Discontinue Study Intervention Due to an AE
Tidsramme: Up to ~37 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be presented. |
Up to ~37 months
|
|
Time to CV Death
Tidsramme: Up to ~37 months
|
CV deaths are defined as any deaths with a primary CV cause, including acute MI, sudden cardiac death, HF, PH worsening, stroke, and other CV causes. The time to CV death will be presented. |
Up to ~37 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 7962-041
- 2025 (U.S. NIH-stipend/kontrakt)
- MK-7962-041 (Annen identifikator: MSD)
- 2025-524634-25-00 (Registeridentifikator: EU CT)
- U1111-1331-4324 (Registeridentifikator: UTN)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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