El objetivo principal de este estudio es evaluar la eficacia y seguridad de LY3540378 en adultos con insuficiencia cardíaca en deterioro con fracción de eyección preservada.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Experienced an index event, defined as a recent hospitalization for HF requiring ≥1 bolus doses of intravenous diuretics or an out- of- hospital encounter (for example, Emergency Room, clinic visit, infusion clinic, etc.) for HF requiring ≥1 bolus doses of intravenous diuretics.
Documented LVEF of ≥50% within 12 months prior to screening; as measured by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computerized tomograph (CT).
Evidence of documentation of LVEF of ≥50% may also include participant medical records, discharge notes or a referral letter from the participant's physician or referring physician that details the participant's medical history.
Had evidence of clinical HF syndrome consisting of hospitalization for worsening heart failure (WHF) with intravascular volume overload (the index event), as determined by the investigator, based on appropriate supportive documentation at randomization, and defined by ≥2 of the following:
dyspnea
jugular venous distention
pitting edema in lower extremities (\>1+)
ascites
pulmonary congestion on chest X-ray
pulmonary rales AND participant received treatment with IV diuretics.
OR
Treatment for an urgent visit outside of of being hospitalized with WHF and intravascular volume overload (the index visit) requiring treatment with IV diuretics (defined as ≥2 IV doses) such as in the outpatient setting/emergency room/observation unit/infusion clinic with a clinical response within the past 2 weeks prior to randomization. Urgent visit is defined as an unplanned visit for HF defined by ≥2 of the following:
dyspnea
jugular venous distention
pitting edema in lower extremities (\>1+)
ascites
pulmonary rales on lung examination.
NT-proBNP (\>300 \[sinus rhythm\] or 600 pg/mL \[atrial fibrillation or atrial flutter\] OR BNP (\>100 \[sinus rhythm\] or 200 pg/mL \[atrial fibrillation or atrial flutter\]) at screening.
eGFR of \>20 mL/min/1.73 m² at V1 (screening; determined by local laboratory), derived from serum creatinine values, age, and sex based on the CKD-EPI equation.

Criterios de exclusión

Prior documentation of low ventricle ejection fraction (LVEF) ≤45% in the past 12 months.
Have had acute coronary syndrome or percutaneous coronary intervention, coronary artery bypass graft, cardiac mechanical support implantation, within 3 months prior to V2. (randomization), - or any other cardiac surgery planned during the study.
Have had left ventricular assist device (LVAD) or cardiac transplantation or have cardiac transplantation planned during the study.
Have hypertrophic cardiomyopathy (obstructive or nonobstructive), restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac sarcoidosis, known amyloid cardiomyopathy, or inherited cardiomyopathy.
Have a chronic pulmonary/lung disease (COPD), (pulmonary arterial hypertension, etc) as defined by chronic oxygen dependence. Night-time oxygen is not exclusionary.
Uncorrected thyroid disease.

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Zarate

Zárate, Buenos Aires, Argentina

Investigaciones Medicas Imoba Srl

Balvanera, Buenos Aires F.D., Argentina

Sanatorio Anchorena Recoleta

Buenos Aires, Buenos Aires F.D., Argentina

Mautalen Salud e Investigación

Buenos Aires, Buenos Aires F.D., Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Buenos Aires F.D., Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

Hospital Provincial del Centenario

Rosario, Santa Fe Province, Argentina

Instituto de Investigaciones Clinicas Rosario

Rosario, Santa Fe Province, Argentina

Sanatorio San Martin

Venado Tuerto, Santa Fe Province, Argentina

Investigaciones Clínicas Tucumán

San Miguel de Tucumán, Tucumán Province, Argentina

CEMEDIC

Buenos Aires, Argentina

Fundación Respirar

Buenos Aires, Argentina

Centro de Investigaciones Clinicas del Litoral

Santa Fe, Argentina

Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

Santa Fe, Argentina

Estudio de fase 2, aleatorizado, doble ciego, controlado con placebo para investigar la eficacia y seguridad de LY3540378 en adultos con insuficiencia cardíaca crónica en deterioro con fracción de eyección preservada (ICFEp)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

LY3540378

Placebo

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)

Instituto de Investigaciones Clinicas Zarate

Investigaciones Medicas Imoba Srl

Sanatorio Anchorena Recoleta

Mautalen Salud e Investigación

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Instituto Médico Río Cuarto

Hospital Provincial del Centenario

Instituto de Investigaciones Clinicas Rosario

Sanatorio San Martin

Investigaciones Clínicas Tucumán

CEMEDIC

Fundación Respirar

Centro de Investigaciones Clinicas del Litoral

Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

Patrocinadores