A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Heart Failure, Heart Failure With Preserved Ejection Fraction

In brief

The main purpose of this study is to assess the efficacy and safety of LY3540378 in adults with worsening heart failure with preserved ejection fraction

Key facts

Study ID

NCT05592275

Run by

Eli Lilly and Company

People needed

332

Starts

2023-02-03

Expected to finish

2025-01-22

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Valley Clinical Trials, Inc. — Covina, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• Pasadena Clinical Research — Pasadena, California, United States
• Velocity Clinical Research, Coastal Heart Medical Group — Santa Ana, California, United States
• Excel Medical Clinical Trials — Boca Raton, Florida, United States
• Infinite Clinical Research — Miami, Florida, United States
• South Florida Research Solutions - North Flamingo Road — Pembroke Pines, Florida, United States
• University Medical Center New Orleans — New Orleans, Louisiana, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States
• University of North Carolina Medical Center — Chapel Hill, North Carolina, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States
• PharmaTex Research — Amarillo, Texas, United States
• Baylor Scott & White Health-Advanced Heart and Lung Disease — Dallas, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• West Houston Area Clinical Trial Consultants — Houston, Texas, United States
• Texas Institute of Cardiology, PA — McKinney, Texas, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• 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
• Pima Heart — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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