Not Yet RecruitingNot Applicable

A Study to Evaluate the Safety and Efficacy of NT-88

60 participantsStarted 2026-03-30

Plain-language summary

A study to evaluate the safety and preliminary efficacy of Zuozhu Daxi in patients with chronic heart failure with mildly reduced ejection fraction

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Aged ≥18 years, no gender restriction;
✓. Willing to participate in the study, understand and sign the informed consent form (ICF);
✓. 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.
✓. Cardiac imaging examination (primarily echocardiography) demonstrating LVEF 41%-49%;
✓. New York Heart Association (NYHA) functional Class II-III (see Appendix 1);
✓. Clinically stable condition with no significant changes in symptoms, signs, or treatment regimen for at least 3 months;
✓. Normal cognitive function.

Exclusion criteria

✕. Known allergy to any component of the investigational product;
✕. 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;
✕. Hospitalization for acute heart failure decompensation within the past 3 months;
✕. Implantation of implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy(CRT) within 3 months;
✕. Uncontrolled hypertension, defined as resting systolic blood pressure ≥180 mmHg and/or diastolicblood pressure ≥110 mmHg at two separate assessments prior to randomization;
✕. 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;
✕. 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.);
✕. Major surgery within 6 months;

What they're measuring

adverse events

Timeframe: Day 1-Day 30

Trial details

NCT IDNCT07509801

SponsorGuangzhou Manjing biomedicine technology co., ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-25

Contact for this trial

Jiexing Chen

18302002029 jxchen@procapzoom.com

View on ClinicalTrials.gov More Heart Failure With Mildly Reduced Ejection Fraction trials