A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
- Conditions
- Heart FailureHeart Failure With Preserved Ejection Fraction
- Registration Number
- NCT05592275
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 456
Inclusion Criteria:<br><br> - Experienced an index event, defined as a recent hospitalization for HF requiring =1<br> bolus doses of intravenous diuretics or an out- of- hospital encounter (for example,<br> Emergency Room, clinic visit, infusion clinic, etc.) for HF requiring =1 bolus doses<br> of intravenous diuretics.<br><br> - Documented LVEF of =50% within 12 months prior to screening; as measured by<br> echocardiography, radionuclide ventriculography, invasive angiography, magnetic<br> resonance imaging (MRI), or computerized tomograph (CT).<br><br> - Evidence of documentation of LVEF of =50% may also include participant medical<br> records, discharge notes or a referral letter from the participant's physician or<br> referring physician that details the participant's medical history.<br><br> - Had evidence of clinical HF syndrome consisting of hospitalization for worsening<br> heart failure (WHF) with intravascular volume overload (the index event), as<br> determined by the investigator, based on appropriate supportive documentation at<br> randomization, and defined by =2 of the following:<br><br> - dyspnea<br><br> - jugular venous distention<br><br> - pitting edema in lower extremities (>1+)<br><br> - ascites<br><br> - pulmonary congestion on chest X-ray<br><br> - pulmonary rales AND participant received treatment with IV diuretics.<br><br>OR<br><br> - Treatment for an urgent visit outside of of being hospitalized with WHF and<br> intravascular volume overload (the index visit) requiring treatment with IV<br> diuretics (defined as =2 IV doses) such as in the outpatient setting/emergency<br> room/observation unit/infusion clinic with a clinical response within the past 2<br> weeks prior to randomization. Urgent visit is defined as an unplanned visit for HF<br> defined by =2 of the following:<br><br> - dyspnea<br><br> - jugular venous distention<br><br> - pitting edema in lower extremities (>1+)<br><br> - ascites<br><br> - pulmonary rales on lung examination.<br><br> - NT-proBNP (>300 [sinus rhythm] or 600 pg/mL [atrial fibrillation or atrial flutter]<br> OR BNP (>100 [sinus rhythm] or 200 pg/mL [atrial fibrillation or atrial flutter]) at<br> screening.<br><br> - eGFR of >20 mL/min/1.73 m² at V1 (screening; determined by local laboratory),<br> derived from serum creatinine values, age, and sex based on the CKD-EPI equation.<br><br>Exclusion Criteria<br><br> - Prior documentation of low ventricle ejection fraction (LVEF) =45% in the past 12<br> months.<br><br> - Have had acute coronary syndrome or percutaneous coronary intervention, coronary<br> artery bypass graft, cardiac mechanical support implantation, within 3 months prior<br> to V2. (randomization), - or any other cardiac surgery planned during the study.<br><br> - Have had left ventricular assist device (LVAD) or cardiac transplantation or have<br> cardiac transplantation planned during the study.<br><br> - Have hypertrophic cardiomyopathy (obstructive or nonobstructive), restrictive<br> cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac sarcoidosis,<br> known amyloid cardiomyopathy, or inherited cardiomyopathy.<br><br> - Have a chronic pulmonary/lung disease (COPD), (pulmonary arterial hypertension, etc)<br> as defined by chronic oxygen dependence. Night-time oxygen is not exclusionary.<br><br> - Uncorrected thyroid disease.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in Left Atrial Reservoir Strain (LARS)
- Secondary Outcome Measures
Name Time Method Change from Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP);Change from Baseline in Left Atrial End-Diastolic Volume Index (LAEDVI);Change from Baseline Left Atrial End-Systolic Volume Index (LAESVI);Change from Baseline in Estimated Glomerular Filtration Rate (eGFR);Change from Baseline in Serum Creatinine;Change from Baseline in cystatin-C