Heart failure with chronic mildly reduced ejection fraction
Conditions
Interventions
Trial Group:Conventional drug therapy + NT-88 (Zuozhudaxi), NT-88 administration: once every 2 days, 4 pills each time, oral administration for 15 times
Control Group:Conventional drug therapy (ARNI/ACEI/ARB/MRA/SGLT2i, etc.), maintain original dosing regimen unchanged
Sponsors
Huizhou Central People‘s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older (inclusive), gender; 2. Willing to participate in the study, understand and sign the informed consent form; 3. Clearly diagnosed as a heart failure patient, with symptoms and/or signs of heart failure: (1) Symptoms: Dyspnea, decreased physical capacity, weakness, fatigue, etc.; (2) Signs: Sparse moist rales in the lungs ("Sparse moist rales" is clinically defined as sparse, discontinuous fine crackles heard during mid-to-late inspiration, typically 1-2 in number, within a limited lung field area), or accompanied by heart murmurs; (3) Examinations (Key for diagnosis): Echocardiography, natriuretic peptide testing, electrocardiogram (ECG); 4. Cardiac imaging examinations (mainly referring to echocardiography) indicate LVEF 41%~49%; 5. New York Heart Association (NYHA) functional classification (see Appendix 1) Class II~III; 6. Stable condition with no significant changes in symptoms, signs, or treatment regimen for at least 3 months; 7. Normal cognitive function.
Exclusion criteria
Exclusion criteria: 1. Known allergy to any component of the investigational product; 2. Complicated with cardiogenic shock, acute severe myocarditis, poorly controlled malignant arrhythmia, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, severe valvular disease requiring surgical intervention, or pulmonary embolism, among others; 3. Hospitalization for acute heart failure decompensation within the past 3 months; 4. Implantation of implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) within 3 months; 5. Uncontrolled hypertension, defined as resting systolic blood pressure >=180 mmHg and/or diastolic blood pressure >=110 mmHg at two separate assessments prior to randomization; 6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or total bilirubin >3 times the upper limit of normal (ULN) due to non-cardiac causes; estimated glomerular filtration rate (eGFR) 5.5 mmol/L; 7. Acute coronary syndrome, stroke, or transient ischemic attack within 3 months; cardiac, carotid, or other major vascular surgery; percutaneous coronary intervention (PCI), carotid angioplasty, coronary artery bypass 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.); 8. Major surgery within 6 months; 9. Serious primary diseases of the liver, kidney, hematopoietic system, nervous system, endocrine system, or other severe systemic diseases; malignancy; or psychiatric disorders; 10. Acute infection; 11. Positive for human immunodeficiency virus (HIV) antibody, positive syphilis test, or hepatitis B or hepatitis C infection; 12. Life expectancy <1 year; 13. Known hypersensitivity to any study drug, or history of chronic urinary tract infection, or prior or planned bariatric surgery; 14. Women who are pregnant, breastfeeding, or planning pregnancy; 15. Participation in another clinical study within 3 months; 16. Subjects deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events within 30 days of treatment and whether there are any subsequent drug-related adverse events observed after the trial ends; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in natriuretic peptide levels from baseline;Change in left ventricular ejection fraction (LVEF) from baseline;Change in cardiac function compared to pre-treatment status;Safety indicators (including vital signs, physical examination, complete blood count, urinalysis, blood biochemistry, coagulation profile, transfusion screening, 12-lead electrocardiogram, chest X-ray, and serum pregnancy test); | — |
Countries
China
Contacts
Public ContactXie Xiongwei
Huizhou Central People‘s Hospital
Outcome results
None listed