The trial is taking place at:
H

Hospital Universitario Virgen de la Victoria | Cardiology Department

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

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Lilly

Status and phase

Enrolling
Phase 2

Conditions

Heart Failure With Preserved Ejection Fraction
Heart Failure

Treatments

Drug: LY3540378
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05592275
J3E-MC-EZDB (Other Identifier)
18473
2023-505902-40-00 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

432 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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. 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 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 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.
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

432 participants in 4 patient groups, including a placebo group

LY3540378 Dose 1
Experimental group
Description:
Participants will receive LY3540378 subcutaneously (SC).
Treatment:
Drug: LY3540378
LY3540378 Dose 2
Experimental group
Description:
Participants will receive LY3540378 SC.
Treatment:
Drug: LY3540378
LY3540378 Dose 3
Experimental group
Description:
Participants will receive LY3540378 SC.
Treatment:
Drug: LY3540378
Placebo
Placebo Comparator group
Description:
Participants will be given placebo SC.
Treatment:
Drug: Placebo

Trial contacts and locations

131

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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