Heart Failure With Mildly Reduced Ejection Fraction
Conditions
Brief summary
A study to evaluate the safety and preliminary efficacy of Zuozhu Daxi in patients with chronic heart failure with mildly reduced ejection fraction
Detailed description
A randomized, single-center, blinded analysis clinical study to evaluate the safety and efficacy of NT-88 inpatients with heart failure with chronic mildly reduced ejection fraction. To evaluate the safety and preliminary efficacy of Zuozhu Daxi in patients with chronic heart failure with mildly reduced ejection fraction
Interventions
DRUGConventional therapeutic drugs
Conventional therapeutic drugs
DRUGNT-88
Conventional therapeutic drugs+NT-88
Sponsors
Guangzhou Manjing biomedicine technology co., ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥18 years, no gender restriction; 2. Willing to participate in the study, understand and sign the informed consent form (ICF); 3. Established diagnosis of heart failure with signs and/or 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. 4. Cardiac imaging examination (primarily echocardiography) demonstrating LVEF 41%-49%; 5. New York Heart Association (NYHA) functional Class II-III (see Appendix 1); 6. Clinically stable condition with no significant changes in symptoms, signs, or treatment regimen for at least 3 months; 7. Normal cognitive function.
Exclusion criteria
1. Known allergy to any component of the investigational product; 2. 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; 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 diastolicblood pressure ≥110 mmHg at two separate assessments prior to randomization; 6. 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) \<15mL/min/1.73 m²; or serum potassium \>5.5 mmol/L; 7. 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.); 8. Major surgery within 6 months; 9. Serious primary diseases of the liver, kidney, hematopoietic system, nervous system, endocrinesystem, 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 orhepatitis C infection; 12. Life expectancy \<1 year; 13. Known hypersensitivity to any study drug, or history of chronic urinary tract infection, or prior orplanned 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 | Description |
|---|---|---|
| adverse events | Day 1-Day 30 | Incidence and severity of adverse events during the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| left ventricular ejection fraction | Day 0, Day 16, Day 30 | Change in left ventricular ejection fraction |
| cardiac function | Day 0, Day 6, Day 30 | Change in cardiac function (New York Heart Association (NYHA) Functional Classification) |
| Natriuretic peptide levels | Day 0, Day 16, Day 30 | Change in natriuretic peptide levels |
Contacts
CONTACTJiexing Chen
Outcome results
None listed