Heart Failure Clinical Trial
A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
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
Eligibility 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. 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.
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) as defined by chronic oxygen dependence. Night-time oxygen is not exclusionary.
Uncorrected thyroid disease.
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There are 97 Locations for this study
Covina California, 91723, United States More Info
Principal Investigator
Northridge California, 91325, United States More Info
Principal Investigator
Orange California, 92868, United States More Info
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Pasadena California, 91105, United States More Info
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Redondo Beach California, 90277, United States More Info
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Santa Ana California, 92704, United States More Info
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Boca Raton Florida, 33434, United States More Info
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Miami Florida, 33133, United States More Info
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Pembroke Pines Florida, 33028, United States More Info
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Boston Massachusetts, 02118, United States More Info
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Detroit Michigan, 48202, United States More Info
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Chapel Hill North Carolina, 27514, United States More Info
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Abington Pennsylvania, 19001, United States More Info
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Amarillo Texas, 79109, United States More Info
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Dallas Texas, 75246, United States More Info
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Dallas Texas, 75390, United States More Info
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Galveston Texas, 77555, United States More Info
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Houston Texas, 77030, United States More Info
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Houston Texas, 77094, United States More Info
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McKinney Texas, 75071, United States More Info
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Zárate Buenos Aires, B2800, Argentina More Info
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Ciudad Autónoma de Buenos Aire Buenos Air, C1027, Argentina More Info
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Buenos Aires Ciudad Autónoma De Buenos Aire, C1128, Argentina More Info
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Buenos Aires Ciudad Autónoma De Buenos Aire, C1179, Argentina More Info
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Río Cuarto Córdoba, X5800, Argentina More Info
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Rosario Santa Fe, S2002, Argentina More Info
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San Miguel de Tucuman Tucumán, 4000, Argentina More Info
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Buenos Aires , C1426, Argentina More Info
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Formosa , 3600, Argentina More Info
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Santa Fe , 3000, Argentina More Info
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Santa Fe , S3000, Argentina More Info
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Goiania Goiás, 74605, Brazil More Info
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Curitiba Paraná, 80230, Brazil More Info
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Aracaju Sergipe, 49055, Brazil More Info
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Campinas São Paulo, 13060, Brazil More Info
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Campinas São Paulo, 13060, Brazil More Info
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Marilia São Paulo, 17515, Brazil More Info
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Ribeirao Preto São Paulo, 14026, Brazil More Info
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Santo André São Paulo, 09080, Brazil More Info
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Sao Paulo São Paulo, 04556, Brazil More Info
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Sao Paulo São Paulo, 05403, Brazil More Info
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Tatui São Paulo, 18270, Brazil More Info
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Rio de Janeiro , 22061, Brazil More Info
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Edmonton Alberta, T5R 4, Canada More Info
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Surrey British Co, V3V 0, Canada More Info
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Cambridge Ontario, N1R 7, Canada More Info
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North York Ontario, M6B 3, Canada More Info
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Oakville Ontario, L6M 1, Canada More Info
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Scarborough Ontario, M1B 4, Canada More Info
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Waterloo Ontario, N2J 1, Canada More Info
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Szeged Csongrád, 6720, Hungary More Info
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Nyiregyhaza Nyíregyháza, 4400, Hungary More Info
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Zalaegerszeg Zala, 8900, Hungary More Info
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Kasugai Aichi, 486-8, Japan More Info
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Chikushino Fukuoka, 818-8, Japan More Info
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Itoshima Fukuoka, 819-1, Japan More Info
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Takasaki Gunma, 370-0, Japan More Info
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Yokohama Kanagawa, 232-0, Japan More Info
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Yokohama Kanagawa, 236-0, Japan More Info
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Yokohama Kanagawa, 236-0, Japan More Info
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Hachioji Tokyo, 192-0, Japan More Info
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Kofu Yamanashi, 400-8, Japan More Info
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Okayama , 701-1, Japan More Info
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Osaka , 540-0, Japan More Info
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Toyama , 930-0, Japan More Info
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Bydgoszcz Kujawsko-pomorskie, 85-23, Poland More Info
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Bydgoszcz Kujawsko-pomorskie, 85-60, Poland More Info
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Lublin Lubelskie, 20-04, Poland More Info
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Krakow Małopolskie, 30-08, Poland More Info
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Oświęcim Małopolskie, 32-66, Poland More Info
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Przemysl Podkarpackie, 37-70, Poland More Info
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Białystok Podlaskie, 15-70, Poland More Info
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Santiago de Compostela A Coruña [La Coruña], 15706, Spain More Info
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Sevilla Andalucía, 41014, Spain More Info
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L'Hospitalet de Llobregat Catalunya [Cataluña], 08907, Spain More Info
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Madrid Madrid, Comunidad De, 28034, Spain More Info
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El Palmar, Murcia Murcia, Región De, 30120, Spain More Info
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Valencia Valenciana, Comunitat, 46010, Spain More Info
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Madrid , 28041, Spain More Info
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High Wycombe Buckinghamshire, HP11 , United Kingdom More Info
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Harrow London, City Of, HA1 3, United Kingdom More Info
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Glasgow Scotland, G31 2, United Kingdom More Info
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Liverpool , L9 7A, United Kingdom More Info
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Manchester , M23 9, United Kingdom More Info
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