A Study to Evaluate the Safety and Efficacy of NT-88
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou Manjing biomedicine technology co., ltd
About this trial
A study to evaluate the safety and preliminary efficacy of Zuozhu Daxi in patients with chronic heart failure with mildly reduced ejection fraction
Eligibility criteria
Qualifiers
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%;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Conventional therapeutic drugs
- NT-88
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov