Heart Failure
Conditions
Interventions
High-intensity treatment group:Intensive GDMT drug titration therapy
Conventional treatment group:Follow-up and drug titration based on clinical experience and treatment protocols
Sponsors
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged >=18 years with heart failure with reduced ejection fraction (HFrEF), LVEF =60 bpm within 24 hours prior to enrollment; 5. Serum potassium 300 pg/mL within 48 hours prior to enrollment; 7. No prior use or <=50% target dose of ACEI/ARB/ARNI or ß-blockers prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. Age under 18 or over 80 years; 2. Documented intolerance to high-dose beta-blockers; 3. Documented intolerance to high-dose RAS blockers (including ACEI/ARB/ARNI); 4. Unable to discontinue the following Chinese herbal preparations or decoctions containing similar ingredients, including hospital-prepared herbal formulations such as: Salvia miltiorrhiza injection, Coronary Heart Disease Relief injection, Blood Circulation Enhancer injection, Ligustrazine powder for injection, Ginkgo biloba extract preparations, Musk Heart Protection Pills, Rapid-acting Heart Rescue Pills, Ligustrazine hydrochloride for injection, Salvia and Ligustrazine Injection, Compound Xueshuantong Capsules, Xueshuantong Injection, Qiliqiangxin Capsules, Shenmai Decoction, Shenmai Injection, etc.; 5. Presence of significant hypotension symptoms or orthostatic hypotension; 6. Hemodynamic instability or requirement for intravenous medications; 7. Received mechanical ventilation within 5 days prior to screening (excluding CPAP/BIPAP); 8. Severe pulmonary disease causing respiratory distress, such as FEV1 130 beats per minute; bradycardia with sustained ventricular arrhythmia < 45 beats per minute); infection; severe anemia; pulmonary embolism; exacerbation of chronic obstructive pulmonary disease; 11. Syncope episodes within 6 months prior to screening that remain unresponsive to treatment; 12. Severe valvular stenosis/regurgitation requiring interventional or surgical intervention within 6 months; 13. History of heart transplantation, or planned device implantation/heart transplant within 6 months; 14. Uncorrected thyroid disease; 15. Active myocarditis or known amyloidosis or hypertrophic cardiomyopathy, and other hypertrophic myocardial diseases (excluding hypertensive cardiac hypertrophy); 16. Stroke or TIA within 3 months prior to screening; 17. Life-threatening primary liver disease or cirrhosis; 18. Renal disease at screening, eGFR < 15 mL/min/1.73m^2 (estimated using simplified MDRD formula), or history of dialysis; 19. Autoimmune, psychiatric, or neurological disorders; 20. Active malignancy with life expectancy < 6 months; 21. Unable to comply with all study requirements due to severe comorbidities, social or economic issues, or history of non-compliance with medical regimens that may impair the patient's ability to understand and/or adhere to the protocol or follow-up procedures; 22. Participation in a chronic heart failure trial or involvement in an investigational drug or device study within 30 days prior to screening (defined as less than 30 days from screening); 23. Patients unable to be discharged within 48 hours post-randomization; 24. Pregnant or lactating women; 25. Inability to attend scheduled visits; 26. Inability to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular death, worsening heart failure or readmission for heart failure at 180d;Change in LVEF from baseline at 180d; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular death at 180d;Worsening heart failure or readmission for heart failure at 180d;All-cause death at 180d;Changes in NT-proBNP in both groups at 180d;Changes in KCCQ-CSS scores in both groups at 180d;Changes in 6-minute walking distances in both groups at at 180d;Changes in cardiac ultrasound indices (LVEDD, E/e', etc.) in both groups at 180d;Proportion and differences in reaching target dose or half target dose at 180d under different treatment strategies; | — |
Countries
China
Contacts
Public ContactYuhui Zhang;Jian Zhang
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed