[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632139":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":28,"locations":24,"responsibleParty":34,"collaborators":24,"id":36,"slug":24,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":24,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":24,"enrollmentInfo":44,"targetDuration":24,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":24,"overallStatus":53,"whyStopped":24,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":24},{"fullName":5,"class":6},"Guangzhou Manjing biomedicine technology co., ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group (Group A)","SHAM_COMPARATOR","Conventional therapeutic drugs",[13],"Drug: Conventional therapeutic drugs",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental group (Group B)","EXPERIMENTAL","Conventional therapeutic drugs+NT-88",[19],"Drug: NT-88",[21,25],{"type":22,"name":11,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":22,"name":26,"description":17,"armGroupLabels":27,"otherNames":24},"NT-88",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Jiexing Chen","CONTACT","18302002029","jxchen@procapzoom.com",{"type":35,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","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":45,"type":46},60,"ESTIMATED","INTERVENTIONAL",[49],"NA","A study to evaluate the safety and preliminary efficacy of Zuozhu Daxi in patients with chronic heart failure with mildly reduced ejection fraction",[52],"Heart Failure With Mildly Reduced Ejection Fraction","NOT_YET_RECRUITING","2026-03-29",{"date":56,"type":57},"2026-04-03","ACTUAL",{"date":59,"type":46},"2026-03-30",{"date":61,"type":46},"2027-06-30",{"name":5,"class":6}]