Heart Failure , Heart Failure With Preserved Ejection Fraction
Conditions
Interventions
-Drug: LY3540378
Administered SC
-Drug: Placebo
Administered SC
Study Arms
-Experimental: LY3540378 Dose 1
Participants will receive LY3540378 subcutaneously (SC).
Intervention: Drug:
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Prior chronic treatment, or prescription, with a loop diuretic (for example, furosemide, torsemide, bumetanide) for >=30 days prior to the index event. Index event is defined as a recent hospitalization for HF requiring at least 2 doses of intravenous diuretics or an out- of- hospital encounter (for example, Emergency Room, clinic visit, infusion clinic, etc.) for HF requiring at least 2 doses of intravenous diuretics. -Chronic HF diagnosed for at least 3 months before V1 (screening). -Documented LVEF of >=50% within 6 months prior to screening; as measured by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computerized tomograph (CT). -Had evidence of clinical HF syndrome consisting of -Hospitalization for HF within the past 2 weeks from randomization, 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 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.
Exclusion criteria
Exclusion criteria: -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) as defined by chronic oxygen dependence. Night-time oxygen is not exclusionary. -Uncorrected thyroid disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Left Atrial Reservoir Strain (LARS) [ Time Frame: Baseline, Week 26 ] | — |
Countries
Argentina, Brazil, Canada, Hungary, Japan, Poland, Spain, United Kingdom, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed