[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577059":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":37,"armGroups":48,"interventions":75,"overallOfficials":87,"centralContacts":91,"locations":96,"responsibleParty":341,"collaborators":37,"id":343,"slug":37,"hasResults":344,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":344,"sex":350,"minAge":351,"maxAge":352,"enrollmentInfo":353,"targetDuration":37,"studyType":356,"phases":357,"briefSummary":359,"conditions":360,"keywords":362,"overallStatus":99,"whyStopped":37,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":381},{"fullName":5,"class":6},"Cytokinetics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":37},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Incidence of early drug discontinuation","Incidence of early drug discontinuation observed during dosing of CK 4021586 in patients with HFpEF","12 weeks",{"measure":14,"description":15,"timeFrame":12},"Incidence of LVEF \u003C 40%","Incidence of left-ventricular ejection fraction (LVEF) \\\u003C 40% observed during dosing of CK-4021586 in patients with HFpEF",{"measure":17,"description":18,"timeFrame":12},"Incidence of AEs","Incidence of adverse events observed during dosing of CK-4021586 in patients with HFpEF",[20,24,27,31,34],{"measure":21,"description":22,"timeFrame":23},"Change in NT-proBNP","Change from baseline values in NT-proBNP to Week 6 and Week 12","Baseline to Week 6 and Week 12",{"measure":25,"description":26,"timeFrame":12},"Plasma concentrations of CK-4021586","Observed 2-hour post dose plasma concentration (C2hr) and minimum plasma concentration (Cmin) for CK-4021586 over the dosing interval",{"measure":28,"description":29,"timeFrame":30},"Concentration-response relationship of CK-4021586 on NT-proBNP change","Slope of the relationship of plasma concentration of CK-4021586 to the change from baseline in the NT-proBNP","Baseline to Week 12",{"measure":32,"description":33,"timeFrame":30},"Concentration-response relationship of CK-4021586 to LVEF change","Slope of the relationship of plasma concentration of CK-4021586 to the change from baseline in the LVEF",{"measure":35,"description":36,"timeFrame":23},"Change in LVEF","Change from baseline in LVEF at Week 6 and Week 12",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":44},"TRIPLE",[45,46,47],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[49,55,61,65,68,72],{"label":50,"type":51,"description":52,"interventionNames":53},"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.",[54],"Drug: CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)",{"label":56,"type":57,"description":58,"interventionNames":59},"Placebo - Cohort 1","PLACEBO_COMPARATOR","Participants will receive placebo daily for up to 12 weeks.",[60],"Drug: Placebo to match CK-4021586",{"label":62,"type":51,"description":63,"interventionNames":64},"CK-4021586 - Cohort 2","Participants may receive 300 mg or 450 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.",[54],{"label":66,"type":57,"description":58,"interventionNames":67},"Placebo - Cohort 2",[60],{"label":69,"type":51,"description":70,"interventionNames":71},"CK-4021586 - Cohort 3","Participants may receive 450 mg or 600 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.",[54],{"label":73,"type":57,"description":58,"interventionNames":74},"Placebo - Cohort 3",[60],[76,83],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"DRUG","CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)","CK-4021586 administered orally",[50,62,69],[82],"ulacamten",{"type":77,"name":84,"description":85,"armGroupLabels":86,"otherNames":37},"Placebo to match CK-4021586","Placebo administered orally",[56,66,73],[88],{"name":89,"affiliation":5,"role":90},"Cytokinetics MD","STUDY_DIRECTOR",[92],{"name":89,"role":93,"phone":94,"phoneExt":37,"email":95},"CONTACT","650-624-2929","medicalaffairs@cytokinetics.com",[97,111,121,131,141,150,159,168,177,187,196,206,216,226,236,246,256,265,271,281,291,301,310,321,331],{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":37},"Eastern Shore Research Institute, LLC","RECRUITING","Fairhope","Alabama","36532","United States","US",{"type":106,"coordinates":107},"Point",[108,109],-87.90333,30.52297,{"lat":109,"lon":108},{"facility":112,"status":99,"city":113,"state":114,"zip":115,"country":103,"countryCode":104,"cosmosGeoPoint":116,"geoPoint":120,"contacts":37},"University of Arizona Sarver Heart Center","Tucson","Arizona","85724",{"type":106,"coordinates":117},[118,119],-110.92648,32.22174,{"lat":119,"lon":118},{"facility":122,"status":99,"city":123,"state":124,"zip":125,"country":103,"countryCode":104,"cosmosGeoPoint":126,"geoPoint":130,"contacts":37},"John L. McClellan Memorial Veterans Hospital","Little Rock","Arkansas","72205",{"type":106,"coordinates":127},[128,129],-92.28959,34.74648,{"lat":129,"lon":128},{"facility":132,"status":99,"city":133,"state":134,"zip":135,"country":103,"countryCode":104,"cosmosGeoPoint":136,"geoPoint":140,"contacts":37},"BioSolutions Clinical Research Center","Imperial","California","92251",{"type":106,"coordinates":137},[138,139],-115.56944,32.84755,{"lat":139,"lon":138},{"facility":142,"status":99,"city":143,"state":134,"zip":144,"country":103,"countryCode":104,"cosmosGeoPoint":145,"geoPoint":149,"contacts":37},"Profound Research LLC","Pasadena","91105",{"type":106,"coordinates":146},[147,148],-118.14452,34.14778,{"lat":148,"lon":147},{"facility":151,"status":99,"city":152,"state":134,"zip":153,"country":103,"countryCode":104,"cosmosGeoPoint":154,"geoPoint":158,"contacts":37},"University of California, San Francisco - Heart and Vascular Center","San Francisco","94143",{"type":106,"coordinates":155},[156,157],-122.41942,37.77493,{"lat":157,"lon":156},{"facility":160,"status":99,"city":161,"state":134,"zip":162,"country":103,"countryCode":104,"cosmosGeoPoint":163,"geoPoint":167,"contacts":37},"FOMAT - Comprehensive Cardiovascular Care","Santa Maria","93454",{"type":106,"coordinates":164},[165,166],-120.43572,34.95303,{"lat":166,"lon":165},{"facility":169,"status":99,"city":170,"state":134,"zip":171,"country":103,"countryCode":104,"cosmosGeoPoint":172,"geoPoint":176,"contacts":37},"Blue Coast Research Center, LLC","Vista","92081",{"type":106,"coordinates":173},[174,175],-117.24254,33.20004,{"lat":175,"lon":174},{"facility":178,"status":99,"city":179,"state":180,"zip":181,"country":103,"countryCode":104,"cosmosGeoPoint":182,"geoPoint":186,"contacts":37},"New Generation of Medical Research","Hialeah","Florida","33016",{"type":106,"coordinates":183},[184,185],-80.27811,25.8576,{"lat":185,"lon":184},{"facility":188,"status":99,"city":189,"state":180,"zip":190,"country":103,"countryCode":104,"cosmosGeoPoint":191,"geoPoint":195,"contacts":37},"Cleveland Clinic Florida","Weston","33331",{"type":106,"coordinates":192},[193,194],-80.39977,26.10037,{"lat":194,"lon":193},{"facility":197,"status":99,"city":198,"state":199,"zip":200,"country":103,"countryCode":104,"cosmosGeoPoint":201,"geoPoint":205,"contacts":37},"Methodist Medical Center of Illinois","Peoria","Illinois","61636",{"type":106,"coordinates":202},[203,204],-89.58899,40.69365,{"lat":204,"lon":203},{"facility":207,"status":99,"city":208,"state":209,"zip":210,"country":103,"countryCode":104,"cosmosGeoPoint":211,"geoPoint":215,"contacts":37},"Louisiana Heart Center","Slidell","Louisiana","70458",{"type":106,"coordinates":212},[213,214],-89.78117,30.27519,{"lat":214,"lon":213},{"facility":217,"status":99,"city":218,"state":219,"zip":220,"country":103,"countryCode":104,"cosmosGeoPoint":221,"geoPoint":225,"contacts":37},"Massachusetts General Hospital","Boston","Massachusetts","02214",{"type":106,"coordinates":222},[223,224],-71.05977,42.35843,{"lat":224,"lon":223},{"facility":227,"status":99,"city":228,"state":229,"zip":230,"country":103,"countryCode":104,"cosmosGeoPoint":231,"geoPoint":235,"contacts":37},"Mayo Clinic","Rochester","Minnesota","55905",{"type":106,"coordinates":232},[233,234],-92.4699,44.02163,{"lat":234,"lon":233},{"facility":237,"status":99,"city":238,"state":239,"zip":240,"country":103,"countryCode":104,"cosmosGeoPoint":241,"geoPoint":245,"contacts":37},"Washington University Center for Advanced Medicine","St Louis","Missouri","63110",{"type":106,"coordinates":242},[243,244],-90.19789,38.62727,{"lat":244,"lon":243},{"facility":247,"status":99,"city":248,"state":249,"zip":250,"country":103,"countryCode":104,"cosmosGeoPoint":251,"geoPoint":255,"contacts":37},"Morristown Medical Center","Morristown","New Jersey","07960",{"type":106,"coordinates":252},[253,254],-74.48154,40.79677,{"lat":254,"lon":253},{"facility":257,"status":99,"city":258,"state":258,"zip":259,"country":103,"countryCode":104,"cosmosGeoPoint":260,"geoPoint":264,"contacts":37},"NYU Langone Health","New York","10016",{"type":106,"coordinates":261},[262,263],-74.00597,40.71427,{"lat":263,"lon":262},{"facility":266,"status":99,"city":258,"state":258,"zip":267,"country":103,"countryCode":104,"cosmosGeoPoint":268,"geoPoint":270,"contacts":37},"Mount Sinai West","10019",{"type":106,"coordinates":269},[262,263],{"lat":263,"lon":262},{"facility":272,"status":99,"city":273,"state":274,"zip":275,"country":103,"countryCode":104,"cosmosGeoPoint":276,"geoPoint":280,"contacts":37},"The Lindner Center for Research & Education at The Christ Hospital","Cincinnati","Ohio","45219",{"type":106,"coordinates":277},[278,279],-84.51439,39.12711,{"lat":279,"lon":278},{"facility":282,"status":99,"city":283,"state":284,"zip":285,"country":103,"countryCode":104,"cosmosGeoPoint":286,"geoPoint":290,"contacts":37},"Oregon Health and Science University","Portland","Oregon","97239",{"type":106,"coordinates":287},[288,289],-122.67621,45.52345,{"lat":289,"lon":288},{"facility":292,"status":99,"city":293,"state":294,"zip":295,"country":103,"countryCode":104,"cosmosGeoPoint":296,"geoPoint":300,"contacts":37},"University of Texas Southwestern Medical Center, Dallas","Dallas","Texas","75390",{"type":106,"coordinates":297},[298,299],-96.80667,32.78306,{"lat":299,"lon":298},{"facility":302,"status":99,"city":303,"state":294,"zip":304,"country":103,"countryCode":104,"cosmosGeoPoint":305,"geoPoint":309,"contacts":37},"Center for Advanced Heart Failure","Houston","77030",{"type":106,"coordinates":306},[307,308],-95.36327,29.76328,{"lat":308,"lon":307},{"facility":311,"status":312,"city":313,"state":314,"zip":315,"country":103,"countryCode":104,"cosmosGeoPoint":316,"geoPoint":320,"contacts":37},"DelRicht Research","WITHDRAWN","Vienna","Virginia","22182",{"type":106,"coordinates":317},[318,319],-77.26526,38.90122,{"lat":319,"lon":318},{"facility":322,"status":99,"city":323,"state":324,"zip":325,"country":103,"countryCode":104,"cosmosGeoPoint":326,"geoPoint":330,"contacts":37},"Swedish Heart & Vascular Institute, Advanced Cardiac Support Program","Seattle","Washington","98122",{"type":106,"coordinates":327},[328,329],-122.33207,47.60621,{"lat":329,"lon":328},{"facility":332,"status":99,"city":333,"state":334,"zip":335,"country":103,"countryCode":104,"cosmosGeoPoint":336,"geoPoint":340,"contacts":37},"Froedtert Hospital - Center for Advanced Care","Milwaukee","Wisconsin","53226",{"type":106,"coordinates":337},[338,339],-87.90647,43.0389,{"lat":339,"lon":338},{"type":342,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","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":354,"type":355},60,"ESTIMATED","INTERVENTIONAL",[358],"PHASE2","This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.",[361],"Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)",[363,364,365,366,367,348,368,369,370,371,82],"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":374,"type":375},"2026-05-29","ACTUAL",{"date":377,"type":375},"2025-02-06",{"date":379,"type":355},"2026-09",{"name":5,"class":6},25]