Heart Failure With Mildly Reduced Ejection FractionNCT07509801
A Study to Evaluate the Safety and Efficacy of NT-88
A study testing Conventional therapeutic drugs and NT-88 in people with Heart Failure With Mildly Reduced Ejection Fraction, run by Guangzhou Manjing biomedicine technology co., ltd.
Trial summary
A study to evaluate the safety and preliminary efficacy of Zuozhu Daxi in patients with chronic heart failure with mildly reduced ejection fraction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Mildly Reduced Ejection Fraction
- What is being tested?
- Conventional therapeutic drugs and NT-88
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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;
- Life expectancy <1 year;
- Known hypersensitivity to any study drug, or history of chronic urinary tract infection, or prior orplanned bariatric surgery;
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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
- Being tested
- Conventional therapeutic drugs, NT-88
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapeutic drugsDrug
Conventional therapeutic drugs
NT-88Drug
Conventional therapeutic drugs+NT-88
| Study group | Role | What they receive |
|---|---|---|
| Control group (Group A) | Sham comparator | Conventional therapeutic drugs Receives: Drug: Conventional therapeutic drugs |
| Experimental group (Group B) | Experimental | Conventional therapeutic drugs+NT-88 Receives: Drug: NT-88 |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Incidence and severity of adverse events during the trial
Measured: Day 1-Day 30
Secondary outcomes (3)
left ventricular ejection fraction
Change in left ventricular ejection fraction
Measured: Day 0, Day 16, Day 30
cardiac function
Change in cardiac function (New York Heart Association (NYHA) Functional Classification)
Measured: Day 0, Day 6, Day 30
Natriuretic peptide levels
Change in natriuretic peptide levels
Measured: Day 0, Day 16, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start30 Mar 2026 (estimated)
- Primary completion25 Feb 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Mildly Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Manjing biomedicine technology co., ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509801
- Sponsor's protocol ID
- PLKR -NT-88-I-101
- Status last verified
- Feb 2026
- First submitted
- 24 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07509801
- Acronym / sponsor ID
- PLKR -NT-88-I-101
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou Manjing biomedicine technology co., ltdIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (Group A) | Sham comparator | Drug: Conventional therapeutic drugsConventional therapeutic drugs |
| Experimental group (Group B) | Experimental | Drug: NT-88Conventional therapeutic drugs+NT-88 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional therapeutic drugsConventional therapeutic drugs | Drug | Control group (Group A) |
| NT-88Conventional therapeutic drugs+NT-88 | Drug | Experimental group (Group B) |
Primary outcome
adverse events
Time frame: Day 1-Day 30
Incidence and severity of adverse events during the trial
3 secondary outcomes
left ventricular ejection fraction
Time frame: Day 0, Day 16, Day 30
cardiac function
Time frame: Day 0, Day 6, Day 30
Natriuretic peptide levels
Time frame: Day 0, Day 16, Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional therapeutic drugs and NT-88 in people with Heart Failure With Mildly Reduced Ejection Fraction, run by Guangzhou Manjing biomedicine technology co., ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiexing Chen (18302002029, jxchen@procapzoom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: Day 1-Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.