A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction

CompletadoFase 3ClinicalTrials.gov

ID: NCT05093933Tipo: INTERVENTIONALInicio: 2 de nov de 2021Fin estimado: 5 de feb de 2025

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

History of chronic HF \[New York Heart Association (NYHA) Class II to IV\] on guideline-directed medical therapy for heart failure (GDMT) with no HF hospitalization within 6 months or outpatient IV diuretic use within 3 months before randomization.
Left ventricular ejection fraction (LVEF) of ≤40%, assessed within 12 months before randomization by any imaging method.
Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.
A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 1 month after the last dose of study intervention.

Criterios de exclusión

Has SBP \<100 mm Hg or symptomatic hypotension.
Awaiting heart transplantation, is receiving continuous IV infusion of an inotrope, or has or anticipates receiving an implanted ventricular assist device.
Amyloidosis or sarcoidosis.
Primary valvular heart disease requiring surgical procedure or intervention or has undergone a valvular surgical procedure or intervention within 3 months before randomization.
Hypertrophic cardiomyopathy.
Acute myocarditis or Takotsubo cardiomyopathy.
History of heart transplant.
Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia.
Acute coronary syndrome, or undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 3 months before randomization.
History of symptomatic carotid stenosis, transient ischemic attack (TIA), or stroke within 3 months before randomization.
Malignancy or other noncardiac condition limiting life expectancy to \<3 years.
Requires continuous home oxygen for severe pulmonary disease.
Interstitial lung disease.
Discontinuation or dose modification of GDMT or vericiguat within 4 weeks before randomization.
Recent history (within the last year) of drug or alcohol abuse or dependence.

Intervenciones

drug

Vericiguat

2.5, 5.0, or 10.0 mg orally once daily

drug

Placebo

0 mg matching placebo for 2.5 mg, 5 mg, and 10 mg of vericiguat

Ubicaciones

CEDIC ( Site 4363)

CABA, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 4352)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

DIM Clínica Privada ( Site 4359)

Ramos Mejía, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Zarate ( Site 4360)

Zárate, Buenos Aires, Argentina

Centro Médico Viamonte-Clinical Research ( Site 4361)

Buenos Aires, Buenos Aires F.D., Argentina

Fundacion Estudios Clinicos ( Site 4356)

Rosario, Santa Fe Province, Argentina

Centro de Investigaciones Clinicas del Litoral ( Site 4354)

Santa Fe, Argentina

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Pivotal Phase 3 Randomized, Placebo-controlled Clinical... | EligiMed