A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection… (NCT05592275) | Clinical Trial Compass
TerminatedPhase 2
A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
Stopped: An interim was conducted and after review of available data, including efficacy evaluation of heart failure events, Lilly is terminating the study due to low likelihood of study success for this HFpEF patient population.
United States332 participantsStarted 2023-02-03
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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/o…
What they're measuring
1
Change From Baseline in Left Atrial Reservoir Strain (LARS) at Week 26