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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Conventional therapeutic drugs
DrugConventional therapeutic drugs
NT-88
DrugConventional therapeutic drugs+NT-88
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control group (Group A)Sham comparator 1 intervention
Group B: Experimental group (Group B)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
adverse events
Incidence and severity of adverse events during the trial
Time frame
Day 1-Day 30Secondary outcomes
1
left ventricular ejection fraction
Change in left ventricular ejection fraction
Time frame
Day 0, Day 16, Day 302
cardiac function
Change in cardiac function (New York Heart Association (NYHA) Functional Classification)
Time frame
Day 0, Day 6, Day 303
Natriuretic peptide levels
Change in natriuretic peptide levels
Time frame
Day 0, Day 16, Day 30Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: