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

  • STATUS
    Recruiting
  • End date
    Jan 8, 2025
  • participants needed
    432
  • sponsor
    Eli Lilly and Company
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Updated on 10 September 2023
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Summary

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

Details
Condition Heart Failure, Heart Failure With Preserved Ejection Fraction
Treatment Placebo, LY3540378
Clinical Study IdentifierNCT05592275
SponsorEli Lilly and Company
Last Modified on10 September 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
Chronic HF diagnosed for at least 3 months before V1 (screening)
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
Had evidence of clinical HF syndrome consisting of
Documented LVEF of ≥50% within 12 months prior to screening; as measured by
echocardiography, radionuclide ventriculography, invasive angiography
dyspnea
magnetic resonance imaging (MRI), or computerized tomograph (CT)
jugular venous distention
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
pitting edema in lower extremities (>1+)
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
ascites
pulmonary congestion on chest X-ray
following
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

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
Uncorrected thyroid disease
Have severe chronic obstructive pulmonary disease (COPD), (pulmonary arterial
hypertension, etc) as defined by chronic oxygen dependence. Night-time oxygen is not
exclusionary
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