[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577059":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":47,"centralContacts":51,"locations":56,"responsibleParty":301,"collaborators":46,"id":303,"slug":304,"hasResults":305,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":305,"sex":311,"minAge":312,"maxAge":313,"enrollmentInfo":314,"targetDuration":46,"studyType":317,"phases":318,"briefSummary":320,"conditions":321,"keywords":323,"overallStatus":59,"whyStopped":46,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},{"fullName":5,"class":6},"Cytokinetics","INDUSTRY",[8,14,20,24,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"CK-4021586 - Cohort 1","EXPERIMENTAL","Participants may receive 150 mg or 300 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.",[13],"Drug: CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo - Cohort 1","PLACEBO_COMPARATOR","Participants will receive placebo daily for up to 12 weeks.",[19],"Drug: Placebo to match CK-4021586",{"label":21,"type":10,"description":22,"interventionNames":23},"CK-4021586 - Cohort 2","Participants may receive 300 mg or 450 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.",[13],{"label":25,"type":16,"description":17,"interventionNames":26},"Placebo - Cohort 2",[19],{"label":28,"type":10,"description":29,"interventionNames":30},"CK-4021586 - Cohort 3","Participants may receive 450 mg or 600 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.",[13],{"label":32,"type":16,"description":17,"interventionNames":33},"Placebo - Cohort 3",[19],[35,42],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)","CK-4021586 administered orally",[9,21,28],[41],"ulacamten",{"type":36,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Placebo to match CK-4021586","Placebo administered orally",[15,25,32],null,[48],{"name":49,"affiliation":5,"role":50},"Cytokinetics MD","STUDY_DIRECTOR",[52],{"name":49,"role":53,"phone":54,"phoneExt":46,"email":55},"CONTACT","650-624-2929","medicalaffairs@cytokinetics.com",[57,71,81,91,101,110,119,128,137,147,156,166,176,186,196,206,216,225,231,241,251,261,270,281,291],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":46},"Eastern Shore Research Institute, LLC","RECRUITING","Fairhope","Alabama","36532","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-87.90333,30.52297,{"lat":69,"lon":68},{"facility":72,"status":59,"city":73,"state":74,"zip":75,"country":63,"countryCode":64,"cosmosGeoPoint":76,"geoPoint":80,"contacts":46},"University of Arizona Sarver Heart Center","Tucson","Arizona","85724",{"type":66,"coordinates":77},[78,79],-110.92648,32.22174,{"lat":79,"lon":78},{"facility":82,"status":59,"city":83,"state":84,"zip":85,"country":63,"countryCode":64,"cosmosGeoPoint":86,"geoPoint":90,"contacts":46},"John L. 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Francisco","94143",{"type":66,"coordinates":115},[116,117],-122.41942,37.77493,{"lat":117,"lon":116},{"facility":120,"status":59,"city":121,"state":94,"zip":122,"country":63,"countryCode":64,"cosmosGeoPoint":123,"geoPoint":127,"contacts":46},"FOMAT - Comprehensive Cardiovascular Care","Santa Maria","93454",{"type":66,"coordinates":124},[125,126],-120.43572,34.95303,{"lat":126,"lon":125},{"facility":129,"status":59,"city":130,"state":94,"zip":131,"country":63,"countryCode":64,"cosmosGeoPoint":132,"geoPoint":136,"contacts":46},"Blue Coast Research Center, LLC","Vista","92081",{"type":66,"coordinates":133},[134,135],-117.24254,33.20004,{"lat":135,"lon":134},{"facility":138,"status":59,"city":139,"state":140,"zip":141,"country":63,"countryCode":64,"cosmosGeoPoint":142,"geoPoint":146,"contacts":46},"New Generation of Medical 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Center","Slidell","Louisiana","70458",{"type":66,"coordinates":172},[173,174],-89.78117,30.27519,{"lat":174,"lon":173},{"facility":177,"status":59,"city":178,"state":179,"zip":180,"country":63,"countryCode":64,"cosmosGeoPoint":181,"geoPoint":185,"contacts":46},"Massachusetts General Hospital","Boston","Massachusetts","02214",{"type":66,"coordinates":182},[183,184],-71.05977,42.35843,{"lat":184,"lon":183},{"facility":187,"status":59,"city":188,"state":189,"zip":190,"country":63,"countryCode":64,"cosmosGeoPoint":191,"geoPoint":195,"contacts":46},"Mayo Clinic","Rochester","Minnesota","55905",{"type":66,"coordinates":192},[193,194],-92.4699,44.02163,{"lat":194,"lon":193},{"facility":197,"status":59,"city":198,"state":199,"zip":200,"country":63,"countryCode":64,"cosmosGeoPoint":201,"geoPoint":205,"contacts":46},"Washington University Center for Advanced Medicine","St Louis","Missouri","63110",{"type":66,"coordinates":202},[203,204],-90.19789,38.62727,{"lat":204,"lon":203},{"facility":207,"status":59,"city":208,"state":209,"zip":210,"country":63,"countryCode":64,"cosmosGeoPoint":211,"geoPoint":215,"contacts":46},"Morristown Medical Center","Morristown","New Jersey","07960",{"type":66,"coordinates":212},[213,214],-74.48154,40.79677,{"lat":214,"lon":213},{"facility":217,"status":59,"city":218,"state":218,"zip":219,"country":63,"countryCode":64,"cosmosGeoPoint":220,"geoPoint":224,"contacts":46},"NYU Langone Health","New York","10016",{"type":66,"coordinates":221},[222,223],-74.00597,40.71427,{"lat":223,"lon":222},{"facility":226,"status":59,"city":218,"state":218,"zip":227,"country":63,"countryCode":64,"cosmosGeoPoint":228,"geoPoint":230,"contacts":46},"Mount Sinai West","10019",{"type":66,"coordinates":229},[222,223],{"lat":223,"lon":222},{"facility":232,"status":59,"city":233,"state":234,"zip":235,"country":63,"countryCode":64,"cosmosGeoPoint":236,"geoPoint":240,"contacts":46},"The Lindner Center for Research & Education at The Christ Hospital","Cincinnati","Ohio","45219",{"type":66,"coordinates":237},[238,239],-84.51439,39.12711,{"lat":239,"lon":238},{"facility":242,"status":59,"city":243,"state":244,"zip":245,"country":63,"countryCode":64,"cosmosGeoPoint":246,"geoPoint":250,"contacts":46},"Oregon Health and Science University","Portland","Oregon","97239",{"type":66,"coordinates":247},[248,249],-122.67621,45.52345,{"lat":249,"lon":248},{"facility":252,"status":59,"city":253,"state":254,"zip":255,"country":63,"countryCode":64,"cosmosGeoPoint":256,"geoPoint":260,"contacts":46},"University of Texas Southwestern Medical Center, Dallas","Dallas","Texas","75390",{"type":66,"coordinates":257},[258,259],-96.80667,32.78306,{"lat":259,"lon":258},{"facility":262,"status":59,"city":263,"state":254,"zip":264,"country":63,"countryCode":64,"cosmosGeoPoint":265,"geoPoint":269,"contacts":46},"Center for Advanced Heart Failure","Houston","77030",{"type":66,"coordinates":266},[267,268],-95.36327,29.76328,{"lat":268,"lon":267},{"facility":271,"status":272,"city":273,"state":274,"zip":275,"country":63,"countryCode":64,"cosmosGeoPoint":276,"geoPoint":280,"contacts":46},"DelRicht Research","WITHDRAWN","Vienna","Virginia","22182",{"type":66,"coordinates":277},[278,279],-77.26526,38.90122,{"lat":279,"lon":278},{"facility":282,"status":59,"city":283,"state":284,"zip":285,"country":63,"countryCode":64,"cosmosGeoPoint":286,"geoPoint":290,"contacts":46},"Swedish Heart & Vascular Institute, Advanced Cardiac Support Program","Seattle","Washington","98122",{"type":66,"coordinates":287},[288,289],-122.33207,47.60621,{"lat":289,"lon":288},{"facility":292,"status":59,"city":293,"state":294,"zip":295,"country":63,"countryCode":64,"cosmosGeoPoint":296,"geoPoint":300,"contacts":46},"Froedtert Hospital - Center for Advanced Care","Milwaukee","Wisconsin","53226",{"type":66,"coordinates":297},[298,299],-87.90647,43.0389,{"lat":299,"lon":298},{"type":302,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100577059","phase-2-amber-hfpef-assessment-of-ck-4021586-in-a-multi-center-blinded-evaluation-of-safety-and-tolerability-results-in-hfpef-100577059",false,"NCT06793371","AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF","A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-4021586 in Adults With Symptomatic Heart Failure With Preserved Ejection Fraction","AMBER-HFpEF","Inclusion Criteria:\n\n* Males and females ≥ 40 years and ≤ 85 years of age at screening.\n* Diagnosed with HF with NYHA functional class II or III.\n* Screening echocardiography with LVEF ≥ 60%.\n* Screening NT-proBNP ≥ 300 pg\u002FmL for participants in sinus rhythm and ≥ 900 pg\u002FmL for participants with comorbid atrial fibrillation or flutter.\n* Body mass index \\\u003C 40 kg\u002Fm2.\n* Participants on beta-blockers, angiotensin-converting enzyme (ACE)\u002Fangiotensin II receptor blocker (ARB) or angiotensin receptor\u002Fneprilysin inhibitor (ARNI), must be on stable doses for more than 30 days prior to screening.\n* Participants on a glucagon-like peptide-1 (GLP-1) agonist must be on a stable dose for more than 24 weeks prior to screening with no anticipated plans to change dose during this study.\n\nExclusion Criteria:\n\n* History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the investigator or the Medical Monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","40 Years","85 Years",{"count":315,"type":316},60,"ESTIMATED","INTERVENTIONAL",[319],"PHASE2","This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.",[322],"Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)",[324,325,326,327,328,309,329,330,331,332,41],"Symptomatic heart failure with preserved ejection fraction","HFpEF","Heart failure","CK-4021586","CK-586","AMBER","Cardiac myosin inhibitor","CMI","CY 9021","2026-05-27",{"date":335,"type":336},"2026-05-29","ACTUAL",{"date":338,"type":336},"2025-02-06",{"date":340,"type":316},"2026-09",{"name":5,"class":6},25]