Not yet recruiting NCT07509801
A Study to Evaluate the Safety and Efficacy of NT-88
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional therapeutic drugs, NT-88.
- Who it may be relevant to
- Registry conditions: Heart Failure With Mildly Reduced Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug Conventional therapeutic drugs
Conventional therapeutic drugs - Drug NT-88
Conventional therapeutic drugs+NT-88
Primary outcome measures
- adverse events [Time frame: Day 1-Day 30]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07509801 · PLKR -NT-88-I-101