Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Andy Yen-Tang Lee
Headshot of Andy Yen-Tang Lee
Andy Yen-Tang Lee

Description

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

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3540378 in Adults With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)

Keywords

Heart Failure, Heart Failure With Preserved Ejection Fraction

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join 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 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.

Locations

  • University of California Irvine Medical Center
    Orange California 92868 United States
  • Velocity Clinical Research, Coastal Heart Medical Group
    Santa Ana California 92704 United States
  • Valley Clinical Trials, Inc.
    Covina California 91723 United States

Lead Scientist at UC Irvine

  • Andy Yen-Tang Lee
    Assistant Health Sciences Professor, Medicine, School of Medicine

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT05592275
Phase
Phase 2 Heart Failure Research Study
Study Type
Interventional
Participants
Expecting 432 study participants
Last Updated