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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
|
|
Komparátor placeba: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to Clinical Worsening (TTCW)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to First Event of CV Death, Hospitalization Due to Worsening HF or PH, or Urgent Visit Due to Worsening HF or PH
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Medical Director, Merck Sharp & Dohme LLC
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 7962-041
- 2025 (Grant/smlouva NIH USA)
- MK-7962-041 (Jiný identifikátor: MSD)
- 2025-524634-25-00 (Identifikátor registru: EU CT)
- U1111-1331-4324 (Identifikátor registru: UTN)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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