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

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Препарат Conventional therapeutic drugs
  Conventional therapeutic drugs
• Препарат NT-88
  Conventional therapeutic drugs+NT-88

Первичные конечные точки

• adverse events [Срок оценки: Day 1-Day 30]

Вторичные конечные точки (3)

• left ventricular ejection fraction [Срок оценки: Day 0, Day 16, Day 30]
• cardiac function [Срок оценки: Day 0, Day 6, Day 30]
• Natriuretic peptide levels [Срок оценки: Day 0, Day 16, Day 30]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07509801 · PLKR -NT-88-I-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗