[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangzhou Manjing biomedicine technology co., ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100632139","a-study-to-evaluate-the-safety-and-efficacy-of-nt-88-100632139",false,"NCT07509801","A Study to Evaluate the Safety and Efficacy of NT-88","A Randomized, Single-center, Blinded Analysis Clinical Study to Evaluate the Safety and Efficacy of NT-88 in Patients With Heart Failure With Chronic Mildly Reduced Ejection Fraction","Inclusion Criteria:\n\n1. Aged ≥18 years, no gender restriction;\n2. Willing to participate in the study, understand and sign the informed consent form (ICF);\n3. Established diagnosis of heart failure with signs and\u002For symptoms of heart failure; Symptoms: Dyspnea, reduced exercise tolerance, fatigue, exhaustion, etc.;Signs: Scattered moist rales in limited lung fields (clinically defined as: sparse, discontinuous, fine bubbling sounds heard in 1-2 localized lung areas during mid-to-late inspiration) or accompanied by mild cardiac murmur; Diagnostic examinations (key for confirmation): Echocardiography, natriuretic peptide testing, electrocardiography.\n4. Cardiac imaging examination (primarily echocardiography) demonstrating LVEF 41%-49%;\n5. New York Heart Association (NYHA) functional Class II-III (see Appendix 1);\n6. Clinically stable condition with no significant changes in symptoms, signs, or treatment regimen for at least 3 months;\n7. Normal cognitive function.\n\nExclusion Criteria:\n\n1. Known allergy to any component of the investigational product;\n2. Complicated with cardiogenic shock, acute severe myocarditis, poorly controlled malignantarrhythmia, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, severevalvular disease requiring surgical intervention, or pulmonary embolism, among others;\n3. Hospitalization for acute heart failure decompensation within the past 3 months;\n4. Implantation of implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy(CRT) within 3 months;\n5. Uncontrolled hypertension, defined as resting systolic blood pressure ≥180 mmHg and\u002For diastolicblood pressure ≥110 mmHg at two separate assessments prior to randomization;\n6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or total bilirubin \\>3 times theupper limit of normal (ULN) due to non-cardiac causes; estimated glomerular filtration rate (eGFR) \\\u003C15mL\u002Fmin\u002F1.73 m²; or serum potassium \\>5.5 mmol\u002FL;\n7. Acute coronary syndrome, stroke, or transient ischemic attack within 3 months; cardiac, carotid, orother major vascular surgery; percutaneous coronary intervention (PCI), carotid angioplasty, coronary arterybypass grafting (CABG), or other cardiac surgery within 3 months; or recent onset of non-cardiac conditions affecting exercise capacity, or conditions that may be exacerbated by vigorous exercise (such as infection,hepatic or renal failure, thyrotoxicosis, etc.);\n8. Major surgery within 6 months;\n9. Serious primary diseases of the liver, kidney, hematopoietic system, nervous system, endocrinesystem, or other severe systemic diseases; malignancy; or psychiatric disorders;\n10. Acute infection;\n11. Positive for human immunodeficiency virus (HIV) antibody, positive syphilis test, or hepatitis B orhepatitis C infection;\n12. Life expectancy \\\u003C1 year;\n13. Known hypersensitivity to any study drug, or history of chronic urinary tract infection, or prior orplanned bariatric surgery;\n14. Women who are pregnant, breastfeeding, or planning pregnancy;\n15. Participation in another clinical study within 3 months;\n16. Subjects deemed unsuitable for participation in this trial by the investigator.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","A study to evaluate the safety and preliminary efficacy of Zuozhu Daxi in patients with chronic heart failure with mildly reduced ejection fraction",[26],"Heart Failure With Mildly Reduced Ejection Fraction","NOT_YET_RECRUITING","2026-03-29",{"date":30,"type":31},"2026-04-03","ACTUAL",{"date":33,"type":20},"2026-03-30",{"date":35,"type":20},"2027-06-30",{"name":37,"class":38},"Guangzhou Manjing biomedicine technology co., ltd","INDUSTRY",""]