Heart failure with preserved ejection fraction
Conditions
Interventions
Control group:(1) Diuretics: Furosemide
add hydrochlorothiazide if control is inadequate
use tolvaptan for patients with hyponatremia. (2) SGLT2 inhibitor: Dapagliflozin. (3) Renin-angiotensin system inhibitor: Sacubitril/valsartan tablets. (4) Aldosterone receptor antagonist: Spironolact
Experimental Group:The control group dosing regimen+ Yiqi Huoxue Formula Granules(Qihuangzhuyu Formula Granules)
Sponsors
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients who fulfill the diagnostic criteria for hypertension and HFpEF (heart failure with preserved ejection fraction) and have an NYHA (New York Heart Association) functional classification of II to IV. 2.Patients who fulfill the TCM (Traditional Chinese Medicine) diagnostic criteria for heart failure with Qi deficiency and blood stasis syndrome. 3.Patients aged between 40 and 80 years regardless of gender. 4.The participant has been fully informed by the research physician understands the study content and voluntarily provides informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with severe cardiomyopathies (including hypertrophic cardiomyopathy dilated cardiomyopathy cardiac amyloidosis Fabry disease etc.) severe valvular heart disease or congenital heart disease; patients who have experienced acute heart failure acute coronary syndrome or undergone percutaneous coronary intervention or cardiothoracic surgery within the past 12 weeks; patients who have experienced cerebrovascular events (such as ischemic stroke or hemorrhagic stroke) within the past 24 weeks. 2.Women who are pregnant or breastfeeding. 3.Patients with severe primary liver lung kidney or hematologic diseases or other conditions that significantly affect survival such as ALT/AST levels exceeding 3 times the upper limit of normal uncontrolled asthma GFR <60 mL/min/1.73 m² or platelet count <70 × 10^9/L. 4.Patients with a history of allergic constitution such as allergies to two or more drugs or foods or known hypersensitivity to any component of the investigational drug. 5.Patients who have used other traditional Chinese medicines or proprietary Chinese medicines for the treatment of heart failure after the onset of the current condition. 6.Patients currently participating in other related clinical trials. 7.Patients who lack full legal capacity or are unable to independently exercise the right to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with =30m improvement in 6MWD at 12 weeks;Improvement in 6-minute walk distance (6MWD) at 12 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Assessment: Minnesota Living with Heart Failure Questionnaire (MLHFQ) 36-Item Short Form Health Survey (SF-36);Cardiovascular events: number of rehospitalizations due to acute heart failure exacerbation number of outpatient visits for acute heart failure exacerbation major adverse cardiovascular events (MACE) (including recurrent angina acute myocardial infarction severe arrhythmia heart failure coronary heart disease death etc. with specific event occurrence times recorded).;Glucose and lipid metabolism assessment: homeostasis model assessment of insulin resistance (HOMA-IR) triglyceride-glucose index (TyG) triglyceride to high-density lipoprotein cholesterol ratio (TG/HDL) estimated glucose disposal rate (eGDR) insulin sensitivity index at fasting (ISIT0).;Inflammation-Related Biomarkers: Interleukin-2 (IL-2) Interleukin-6 (IL-6) Tumor necrosis factor-alpha (TNF-a) Interferon-gamma (IFN-?) High-sensitivity C-reactive protein (hs-CRP);Psychological Assessment: Hamilton Depression Rating Scale (HAMD) Hamilton Anxiety Rating Scale (HAMA);Proportion of patients with =30m improvement in 6-minute walk distance (6MWD) at 24 weeks;Neuroendocrine factors: N-terminal pro-B-type natriuretic peptide (NT-proBNP) soluble suppression of tumorigenicity 2 (sST-2) galectin-3 (Gal-3) N-terminal propeptide of type III procollagen (PIIINP).;Doppler echocardiography: mitral early diastolic inflow velocity (E)/mitral annular early diastolic myocardial velocity (e') ratio (E/e') peak tricuspid regurgitation velocity left atrial volume index (LAVI) septal e' velocity lateral e' velocity relative wall thickness (RWT) sphericity index left ventricular end-diastolic volume (LVEDV) left ventricular end-systolic volume (LVESV) E/e' ratio measurement.;Traditional Chinese Medicine (TCM) Syndrome Evaluation: TCM syndrome scoring scale;Cardiac magnetic resonance (CMR): left ventricular ejection fraction (LVEF) left ventricular volume (LVV) right ventricular volume (RVV) left vent | — |
Countries
China
Contacts
Public Contactchen xiaohu
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed