Last updated 59 days ago
A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
456 patients around the world
Available in Argentina, United States, Brazil, Spain
Eli Lilly and Company
29Research sites
456Patients around the world
This study is for people with
Heart failure
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Prior chronic treatment, or prescription, with a loop diuretic (for example, furosemide, torsemide, bumetanide) for ≥30 days prior to the index event. Medical records, discharge notes and physician referral letters may serve as documentation for prior chronic treatment with a loop diuretic.Experienced an index event, defined as a recent hospitalization for HF requiring ≥2 bolus doses of intravenous diuretics or an out- of- hospital encounter (for example, Emergency Room, clinic visit, infusion clinic, etc.) for HF requiring ≥2 bolus doses of intravenous diuretics.Chronic HF diagnosed for at least 3 months before V1 (screening)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 ofTreatment 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:NT-proBNP (>300 [sinus rhythm] or 900 picograms/milliliter (pg/mL) [atrial fibrillation or atrial flutter] OR brain natriuretic (BNP) (>100 [sinus rhythm] or 300 pg/mL [atrial fibrillation or atrial flutter]) at screening.Note: The presence or absence of atrial fibrillation or atrial flutter to determine the appropriate cut-off for a given BNP or NT-proBNP sample should be evaluated using electrocardiogram (ECG) performed at screening prior to the collection of the BNP or NT-proBNP sample.
- 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 day 2. (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 severe chronic obstructive pulmonary disease (COPD), (pulmonary arterial hypertension, etc) as defined by chronic oxygen dependence. Night-time oxygen is not exclusionary.Uncorrected thyroid disease.
Sites
Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
Instituto de Investigaciones Clínicas Tucumán
Recruiting
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Recruiting
Instituto Médico Río Cuarto
Recruiting
Centro Especialidades Médicas SRL (CEMEDIC)
Recruiting
Centro de Investigaciones Clínicas del Litoral SRL
Recruiting
Investigaciones Médicas IMOBA SRL
Recruiting
Instituto de Investigaciones Clínicas Zárate
Recruiting
Clínica de Nefrología Urología y Enfermedades Cardiovasculares - Santa Fe
Recruiting
Pontifícia Universidade Católica do Paraná - PUCPR
Recruiting
StudyHFpEF
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Heart failure
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05592275
