A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

ReclutandoFase 2ClinicalTrials.gov

ID: NCT06122779Tipo: INTERVENTIONALInicio: 7 de nov de 2023Fin estimado: 3 de jul de 2026

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

\- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability.

Criterios de exclusión

Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant.

Intervenciones

drug

BMS-986435

Specified dose on specified days

other

Placebo

Specified dose on specified days

Ubicaciones

Corporación Médica de General San Martín

Ciudad del Libertador General San Martín, Buenos Aires, Argentina

Rodolfo Ahuad Guerrero, Site 0054 · 541147547561

RECRUITING

Local Institution - 0107

Zárate, Buenos Aires, Argentina

WITHDRAWN

Local Institution - 0115

Zárate, Buenos Aires, Argentina

Site 0115

NOT_YET_RECRUITING

Local Institution - 0090

Córdoba, Córdoba Province, Argentina

Site 0090

NOT_YET_RECRUITING

Local Institution - 0053

Córdoba, Córdoba Province, Argentina

Site 0053

NOT_YET_RECRUITING

Local Institution - 0073

Rosario, Santa Fe Province, Argentina

Site 0073

NOT_YET_RECRUITING

IPR-Investigaciones en Patologías Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

Lilia Luz Lobo Marquez, Site 0061 · +548888888888

RECRUITING

Centro de Especialidades Médicas CEMEDIC

Buenos Aires, Argentina

Claudio Majul, Site 0060 · +541146305763

RECRUITING

Local Institution - 0068

Buenos Aires, Argentina

WITHDRAWN

Local Institution - 0067

Buenos Aires, Argentina

Site 0067

NOT_YET_RECRUITING

Sanatorio Duarte Quiros

Córdoba, Argentina

Hugo Colombo, Site 0074 · +543514891398

RECRUITING

Local Institution - 0069

Salta, Argentina

Site 0069

NOT_YET_RECRUITING

Centro de Investigaciones Clínicas Del Litoral SRL

Santa Fe, Argentina

Miguel Hominal, Site 0102 · +5493426126156

RECRUITING

Patrocinadores

PrincipalBristol-Myers Squibb

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

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