Heart failure
Conditions
Interventions
Observation group (Chronic HFrEF patients (baseline LVEF <=40%)):None
Sponsors
RuiJin Hospital LuWan Branch, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 years and 4 weeks) optimized guideline-directed medical therapy (GDMT) and/or device therapy. 3.Left ventricular ejection fraction (LVEF) =1000 pg/mL Af patients with baseline NT-proBNP=600 pg/mL: Baseline NT-proBNP>=1200 pg/mL (4) HF rehospitalization patients (EF=600 pg/mL: Baseline NT-proBNP>=1200 pg/mL; 5.Must be receiving standard HFrEF pharmacological therapy (unless contraindicated or intolerant) and be on a stable regimen (=4 weeks, excluding diuretic dose adjustments). The regimen must include the following agents, as applicable: ACE inhibitor, ARB, or sacubitril/valsartan (ARNI) + beta-blocker + mineralocorticoid receptor antagonist (MRA, if applicable) + sodium-glucose cotransporter 2 inhibitor (SGLT2i). (The use of novel agents such as vericiguat is permitted and should be noted.); 6.Estimated glomerular filtration rate (eGFR) >=20 mL/min/1.73 m^2 at enrollment (calculated using the CKD-EPI formula). 7.Capable of providing signed informed consent, including compliance with the requirements and restrictions listed in the ICF and this protocol.
Exclusion criteria
Exclusion criteria: 1.Poor adherence to therapy, potentially leading to worsening HF symptoms and signs due to non-compliance with prescribed medication. 2.Systolic blood pressure (SBP) = 1.5 × upper limit of normal (ULN) or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >= 3 × ULN (patients with a history of Gilbert's syndrome and unconjugated hyperbilirubinemia leading to TBL >= 1.5 × ULN but without other signs of hepatic impairment may be enrolled). 15.Known blood-borne infectious diseases. 16.Severe or unstable renal disease: eGFR = 160 mmHg (if treated with < 3 antihypertensive agents) or = 180 mmHg (regardless of treatment) at enrollment. 18.Hemoglobin level < 9 g/dL. 19.Major surgery (as assessed by the investigator) within 90 days prior to enrollment, or planned major elective surgery (e.g., hip replacement) within 90 days after screening. 20.Patients with paroxysmal or permanent atrial fibrillation will be excluded only if: (1) Cardioversion (e.g., direct current cardioversion, atrial fibrillation ablation, or antiarrhythmic therapy) was required <= 3 months prior to screening. (2)Rate control has not been consistently maintained for at least 3 months prior to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory tests (blood routine, biochemical, hs-CRP, NT-proBNP and troponin);Demographics;Medical history;Taking medication;Imaging (cardiac ultrasound, electrocardiogram); | — |
Countries
China
Contacts
Public ContactWei Jin
RuiJin Hospital LuWan Branch, Shanghai Jiaotong University School of Medicine
Outcome results
None listed