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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure With Mildly Reduced Ejection Fraction
• Intervention / Treatment: Drug: Conventional therapeutic drugs; Drug: NT-88

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiexing Chen; Phone Number: 18302002029; Email: jxchen@procapzoom.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group (Group A); Conventional therapeutic drugs	Drug: Conventional therapeutic drugs; Conventional therapeutic drugs
Experimental: Experimental group (Group B); Conventional therapeutic drugs+NT-88	Drug: NT-88; Conventional therapeutic drugs+NT-88

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	Incidence and severity of adverse events during the trial	Day 1-Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
left ventricular ejection fraction	Change in left ventricular ejection fraction	Day 0, Day 16, Day 30
cardiac function	Change in cardiac function (New York Heart Association (NYHA) Functional Classification)	Day 0, Day 6, Day 30
Natriuretic peptide levels	Change in natriuretic peptide levels	Day 0, Day 16, Day 30

Collaborators and Investigators

• Sponsor: Guangzhou Manjing biomedicine technology co., ltd

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PLKR -NT-88-I-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No