[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07436689":3,"trial-entities:NCT07436689":116,"trial-summary:NCT07436689":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":17,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":46,"std_ages":57,"locations":61,"central_contacts":112,"overall_officials":113,"references":114,"see_also_links":115},"NCT07436689","TNX-103-08","Long-Term Open-Label Extension Study of Oral Levosimendan","A Multicenter, Open-Label, Long-Term Extension Study for Oral Levosimendan (TNX-103)","ENROLLING_BY_INVITATION","2029-03","2026-07","2026-07-20","2026-03-13","Tenax Therapeutics, Inc.","INDUSTRY",false,"The purpose of this study is to provide continued access to treatment with oral levosimendan (TNX-103) and to describe the safety of continued use of TNX-103 in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) who received TNX-103 in a parent study.",null,[19],"Pulmonary Hypertension Associated With HFpEF",[21,22,23,24,25],"PH-HFpEF","levosimendan","HFpEF","Heart Failure","Pulmonary Hypertension Group 2","INTERVENTIONAL","TREATMENT",[29],"PHASE3",{"count":31,"type":32},800,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","TNX-103","Open-label oral levosimendan 1-3mg",[36],[40],{"measure":41,"description":42,"timeFrame":43},"The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE\u002FSAEs","The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE\u002FSAEs will be tabulated by system organ class and preferred term.","From enrollment through study completion (up to 3 years)",[],"ALL",{"inclusion":47,"exclusion":51,"raw_text":56},[48,49,50],"Completed a TNX-103 parent study","Investigator confirmation that participant may derive clinical benefit from continued access to TNX-103","Requirements related to childbearing potential, contraception, and egg\u002Fsperm donation",[52,53,54,55],"Investigator or Sponsor opinion that the participant is unsuitable due to safety, inability to comply, or factors that could compromise study integrity or participant well-being","Severe hepatic impairment or cirrhosis (Child-Pugh C) or active untreated hepatitis B or C with evidence of recent infection or viral replication","Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m²","Pregnancy or breastfeeding in females","Inclusion Criteria:\n\n* Completed a TNX-103 parent study\n* Investigator confirmation that participant may derive clinical benefit from continued access to TNX-103\n* Requirements related to childbearing potential, contraception, and egg\u002Fsperm donation\n\nExclusion Criteria:\n\n* Investigator or Sponsor opinion that the participant is unsuitable due to safety, inability to comply, or factors that could compromise study integrity or participant well-being\n* Severe hepatic impairment or cirrhosis (Child-Pugh C) or active untreated hepatitis B or C with evidence of recent infection or viral replication\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m²\n* Pregnancy or breastfeeding in females",[58,59,60],"CHILD","ADULT","OLDER_ADULT",[62,71,78,84,91,98,105],{"facility":63,"city":64,"state":65,"zip":66,"country":67,"geoPoint":68},"Tenax Investigational Site","Chicago","Illinois","60611","United States",{"lat":69,"lon":70},41.85003,-87.65005,{"facility":63,"city":72,"state":73,"zip":74,"country":67,"geoPoint":75},"Minneapolis","Minnesota","55455",{"lat":76,"lon":77},44.97997,-93.26384,{"facility":63,"city":79,"state":73,"zip":80,"country":67,"geoPoint":81},"Rochester","55905",{"lat":82,"lon":83},44.02163,-92.4699,{"facility":63,"city":85,"state":86,"zip":87,"country":67,"geoPoint":88},"St Louis","Missouri","63136",{"lat":89,"lon":90},38.62727,-90.19789,{"facility":63,"city":92,"state":93,"zip":94,"country":67,"geoPoint":95},"Omaha","Nebraska","68198",{"lat":96,"lon":97},41.25626,-95.94043,{"facility":63,"city":99,"state":100,"zip":101,"country":67,"geoPoint":102},"Charleston","South Carolina","29425",{"lat":103,"lon":104},32.77632,-79.93275,{"facility":63,"city":106,"state":107,"zip":108,"country":67,"geoPoint":109},"Madison","Wisconsin","53792",{"lat":110,"lon":111},43.07305,-89.40123,[],[],[],[],{"nct_id":4,"conditions":117,"biomarkers":118},[19],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]