heart failure
Conditions
Interventions
Observe group (On the basis of the "Standard Quadruple" scheme, in collaboration with Vericiguat):NA
control group (the "Standard Quadruple" scheme):NA
Sponsors
Xijing Hospital, Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) age: at least 18 years old; (2) At least 3 months of symptoms of heart failure, NYHA classification II, III, or IV; (3) Left ventricular ejection fraction below 45% within 12 months; (4) NT proBNP level >= 600pg/ml within 30 days; Or NT proBNP >= 400pg/ml in patients with previous heart failure; Or NT proBNP >= 900pg/ml in patients with previous concomitant atrial fibrillation; (5) Following the expert consensus on the clinical decision-making pathway of "New Four Combination" drug therapy for chronic heart failure, accept the "Standard Four Combination" treatment regimen of sacubitril valsartan+sodium glucose cotransporter 2 inhibitor+ß - receptor blocker+mineralocorticoid antagonist or the "Standard Four Combination"+Viliximab treatment regimen, and achieve the target dose or maximum tolerated dose within 4 weeks; (6) The patient receives follow-up after treatment and the data is complete; (7) Agree to undergo endocardial biopsy and collection of blood and urine samples, complete imaging examinations, and undergo specialized evaluations for this trial; (8) A written informed consent form has been signed before the start of the experimental activities.
Exclusion criteria
Exclusion criteria: (1) Unstable clinical status, including systolic blood pressure below 100mmHg, symptomatic hypotension, or receiving intravenous medication for heart failure within 24 hours (positive inotropic drugs, recombinant human brain natriuretic peptide, etc.); (2) Heart failure caused by complex congenital heart disease, active endocarditis, systolic pericarditis, hypertrophic cardiomyopathy, pericardial disease, invasive/inflammatory cardiomyopathy, amyloidosis, sarcoidosis, Takotsubo cardiomyopathy, heart transplant induced cardiomyopathy or cardiovascular disease, and severe valve disease; (3) Cardiomyopathy induced by tachycardia and/or uncontrolled tachycardia; (4) Acute coronary syndrome (unstable angina, non ST segment elevation myocardial infarction, or ST segment elevation myocardial infarction) or coronary artery reconstruction surgery (coronary artery bypass grafting or percutaneous coronary intervention), or coronary artery revascularization performed within 3 months prior to enrollment; (5) History of cardiac surgery, symptomatic carotid stenosis, stroke, or transient ischemic attack within the past 3 months; (6) Currently using or expected to use long-acting nitrate or NO donor drugs (including isosorbide dinitrate, 5-monoisosorbide dinitrate, pentaerythritol tetranitrate, nicorandil, transdermal nitroglycerin patches, sodium nitroprusside, and metformin, but not sublingual nitroglycerin), sGC activators (Viliximab, Leosigimab), or phosphodiesterase-5 inhibitors (Vardenafil, Tadalafil, and Sildenafil); (7) Patients waiting for heart transplantation, currently using implantable left ventricular assist devices, or planning to implant related devices; (8) Symptomatic bradycardia patients or II-III grade heart block patients without implanted pacemakers; (9) Severe liver dysfunction, such as hepatic encephalopathy; (10) Rapid progression of kidney disease or severe renal insufficiency, eGFR<20 mL/min/1.73 m^2; (11) Having interstitial lung disease, pulmonary arterial hypertension, or other serious lung diseases that require home oxygen therapy; (12) Alcohol or drug abuse; (13) Pregnant or lactating women, and women of childbearing age who have not taken effective contraceptive measures; (14) Previous mental illness affecting clinical evaluation; (15) There are contraindications for cardiac MRI examination; (16) There are contraindications for endometrial biopsy, including bleeding disorders, severe thrombocytopenia, and those undergoing anticoagulant therapy; Patients with left ventricular wall thrombus formation or ventricular aneurysm formation; Patients with significant enlargement of the heart and severe left heart dysfunction; Recently, there have been infected individuals; Patients who cannot cooperate well; Patients with shunt defects; (17) Having cancer or other life-threatening diseases, with an expected life expectancy of less than 6 months; (18) Participated in clinical studies of other drugs within the past month; (19) Any other diseases or conditions that the researcher deems unsuitable for inclusion in the study; (20) Known history of allergies to active substances or any of their components in research related drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cardiovascular death;First hospitalization due to heart failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood pressure;NT-proBNP;renal function;CMR;echocardiogram;NYHA cardiac function classification;Kansas City Cardiomyopathy Questionnaire-12;heart rate;RDS scale;Heart failure exacerbation self-measurement scale;AD-7 scale;PHQ-9 scale;Athens Insomnia Scale;EQ-5D Quality of Life Scale;Clinical Frailty Scale;FRAIL Scale; | — |
Countries
China
Contacts
Public ContactLian Kun
Xijing Hospital
Outcome results
None listed