NCT07509801Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
A study to evaluate the safety and preliminary efficacy of Zuozhu Daxi in patients with chronic heart failure with mildly reduced ejection fraction
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 24 Mar 2026
- Start date
- Mar 2026
- Primary completion date
- Feb 2027
- Lead sponsor
- Guangzhou Manjing biomedicine technology co., ltd
- Diseases
- Heart failure
- NCT number
- NCT07509801
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Mar 2026 to the primary completion date, Feb 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known allergy to any component of the investigational product;
- Uncontrolled hypertension, defined as resting systolic blood pressure ≥180 mmHg and/or diastolicblood pressure ≥110 mmHg at two separate assessments prior to randomization;
- Major surgery within 6 months;
- Known hypersensitivity to any study drug, or history of chronic urinary tract infection, or prior orplanned bariatric surgery;
Other illness
- 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;
- 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.);
- Serious primary diseases of the liver, kidney, hematopoietic system, nervous system, endocrinesystem, or other severe systemic diseases; malignancy; or psychiatric disorders;
- Acute infection;
- Positive for human immunodeficiency virus (HIV) antibody, positive syphilis test, or hepatitis B orhepatitis C infection;
Lab values
- 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;
Other
- Life expectancy \<1 year;
- Women who are pregnant, breastfeeding, or planning pregnancy;
- Participation in another clinical study within 3 months;
- Subjects deemed unsuitable for participation in this trial by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.