Chronic heart failure with reduced ejection fraction
Conditions
Interventions
GDMT and transcatheter endocardial injection of implantable alginate hydrogel:GDMT and transcatheter endocardial injection of implantable alginate hydrogel
Guidelines guide the pharmacotherapy group:Guidelines guide pharmacotherapy
Sponsors
First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and = 15% and 150 pg/ml, or adjusted NT-pro BNP >600 pg/ml,(Note:When the BMI is higher than 20kg/m2, the cutoff value of NT-pro BNP decreased by 4% for every 1 kg/m2 increase in BMI); and the subject still has symptoms of heart failure after at least 30 days of GDMT; Note: BNP or NT-proBNP must be obtained after the subject has received stable optimal therapy including Guideline Directed Medical Therapy (GDMT) or at least 30 days after: Coronary artery revascularization and/or implantation of a cardiac resynchronization therapy device (CRT-P or CRT-D), or reprogramming of an implanted CRT-P or CRT-D to increase biventricular pacing (from =92% ). 6. The subject has been informed of the nature of this study, understood the purpose of the clinical trial, voluntarily participates and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Any cardiovascular interventional operation within 30 days; or cardiac surgery within 6 months; or cardiac pacemaker therapy or cardiac resynchronization therapy (CRT-P, CRT-D) or implanted cardioverter-defibrillator (ICD) implantation within 30 days; 2. History of acute myocardial infarction or unstable angina pectoris within 4 weeks, or untreated severe coronary artery stenosis requiring revascularization; Note: If the need for coronary artery revascularization cannot be confirmed, the results of fractional flow reserve should be provided. (such as fractional flow reserve, quantitative flow fraction, or instantaneous waveform-free ratio, etc.); 3. Acute or acute on top of the chronic heart at decompensated state, or NYHA IVb; 4. Echocardiographic evidence of LV intracardiac mass, thrombus or vegetation;5. Severe valvular heart disease which requires intervention or Chronic moderate to severe (3+) or severe (4+) mitral regurgitation with clinical symptoms.; or needs coronary artery bypass grafting or on LVAD and other MCS, or have previous heart transplant; 6. Heart failure on the basis other than ischemic or non-ischemic dilated cardiomyopathy (e.g., hypertrophic cardiomyopathy with or without obstruction, restrictive cardiomyopathy, constrictive pericarditis, uncorrected congenital heart disease, infiltrative cardiomyopathy such as amyloidosis, hemochromatosis, granuloma, etc.);7. Severe chronic obstructive pulmonary disease requiring continuous home oxygen therapy or long-term steroid therapy;8. Severe right heart dysfunction or fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy;9. History of cerebrovascular accident (ischemic) within 90 days, or severe symptomatic carotid artery stenosis (stenosis >70% measured by echocardiography); or carotid stenting within 30 days; history of cerebrovascular accident (hemorrhagic) within 6 months;10. Modified Rankin scale score >= 4 points; Note: The modified Rankin scale is only used to measure the results of functional recovery after stroke.11. (Estimated) glomerular filtration rate (eGFR) < 25 ml/min/1.73 m2;12. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2.5 times the upper limit of normal;13. Bacterial endocarditis; active rheumatic heart disease, or rheumatic disease resulting in valve leaflet disease (poor compliance, perforation, etc.); or known deep vein thrombosis of lower limbs;14. The thickness of the LV free-wall at the injections sites was less than 5 mm by CT; moderate or greater aortic valve calcification or stenosis, significant aortic atheroma, aortic aneurysm, aortic type A dissection or obstruction, aortic intramural hematoma, penetrating aortic ulcer, or other anatomical structures unsuitability;15. There are contraindications for transesophageal echocardiography or intracardiac echocardiography; or there are contraindications for general anesthesia; 16. Hemodynamic instability, defined as systolic blood pressure <90mmHg without afterload-reducing drugs with symptoms of hypoperfusion, or cardiogenic shock; or requiring vasoactive drug therapy; or requiring intra-aortic balloon counterpulsation or other hemodynamic support devices;17. Active infection, need to receive antibiotics treatment at the same time (if it is a temporary disease, the patient must be enrolled at least 14 days after the antibiotic is stopped); 18. Pregnant and lactating women; or a woman who plans to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality or hospitalization for heart failure or improvement of = 15 points in the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 months.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in left ventricular volume, ejection fraction, and left ventricular diastolic function assessed by echocardiography from baseline to before discharge, 1 month, 6 months, and 12 months after the procedure;;Change in left ventricular volume, left ventricular mass(LVMI),ejection fraction, LVEDVI, LVESVI and left ventricular diastolic function assessed by MRI from baseline to 6 months, 12 months after the procedure;;Change in NT-proBNP from baseline to 1 months, 6 months, 12 months after the procedure;Change in 6-minute walk distance from baseline to 1 months, 6 months, 12 months after the procedure;;Change in NYHA classification from baseline to 1 months, 3 months, 6 months, 12 months after the procedure;Change in KCCQ score from baseline to 1 months, 6 months, 12 months after the procedure;;Overall incidence of reoperation/intervention for heart failure within 6 months after the procedure;Overall incidence of rehospitalization for heart failure within 6 months after the procedure;All-cause mortality at 6 months;Acute device success;Acute technology success;Incidence of major adverse events within 30 days after the procedure;Incidence of serious adverse events within 6 months after the procedure;Incidence of device defects; | — |
Countries
China
Contacts
Public ContactTao Ling
First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed