ejection fraction preserving heart failure
Conditions
Interventions
Experimental group:Standard treatment + Fuzheng Yangxin decoction
Control group:Standard treatment + placebo
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age = 18 and = 80 years old, gender unlimited; (2) TCM syndrome differentiation is Qi and yin deficiency and blood stasis syndrome; (3) Cardiac function classification (NYHA classification) belongs to class II-III (hemodynamic stability); (4) According to the diagnostic criteria of HFPEF in the national heart failure guidelines 2023: 1) With the epidemiological and population characteristics of patients with HFPEF; 2) Have symptoms and / or signs of heart failure (such as dyspnea, decreased activity tolerance, edema, etc.); 3) Echocardiography showed left ventricular ejection fraction (LVEF) = 50%; 4) There is objective evidence of abnormal cardiac structure and / or function consistent with left ventricular diastolic dysfunction and / or elevated left ventricular filling pressure (including ? the ratio of early diastolic peak velocity of mitral flow spectrum to early diastolic peak velocity of mitral annulus (e/e') > 15; ? Interval e' 2.8m/s or estimated pulmonary artery systolic pressure (PASP) > 35mmhg; ? The level of left atrial volume index (Lavi) increased (patients with sinus rhythm: Lavi > 34ml/m2, patients with atrial fibrillation: Lavi > 40ml/m2); ? The level of natriuretic peptides (NPS) increased; (5) Voluntarily participate in this clinical trial, understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Previous cardiac color Doppler ultrasonography showed that left ventricular ejection fraction (LVEF) 5.5mmol/l; (4) Acute coronary syndrome, stroke, transient ischemic attack occurred within 3 months; Cardiac, carotid or other large vessel surgery; Percutaneous coronary intervention (PCI) or carotid angioplasty or coronary artery bypass grafting and other cardiac surgery, or recent occurrence of non cardiac diseases that can affect exercise capacity, or suffering from diseases that can be exacerbated by intense exercise (such as infection, liver and kidney failure, thyrotoxicosis, etc.); (5) Patients with liver, kidney, hematopoietic system, nervous system, endocrine system and other serious primary diseases, tumor patients and psychiatric patients; (6) Life expectancy less than 1 year; (7) Known allergy to any test drug and chronic urinary tract infection and other diseases; (8) Those who participate in clinical research of other drugs within 1 month; (9) Patients who are taking traditional Chinese medicine and Chinese patent medicine similar to Fuzheng Yangxin formula; (10) Pregnancy (positive urine pregnancy test) or lactation; Women of childbearing age who do not use contraception; (11) According to the judgment of the investigator, the patient could not complete the study or comply with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| peakVO2; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality;Composite end point events (treatment abandoned for worsening heart failure, successful resuscitation after cardiac arrest, malignant arrhythmia, nonfatal stroke, hospitalization for heart failure);6min walking distance;Serum NT-proBNP;LVEF;Left ventricular posterior wall thickness;Interventricular septal thickness;Peak tricuspid regurgitation velocity;LAVI;E/e';TCM syndrome integral;Minnesota Heart Failure Quality of Life Questionnaire score;FRAIL frailty scale score;PFR;LVEF ;Whole blood viscosity;plasma viscosity;fibrinogen;erythrocyte sedimentation rate;platelet aggregation test; | — |
Countries
China
Contacts
Public ContactXiaochang Ma
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed