Heart Failure with Preserved Ejection Fraction
Conditions
Interventions
Experimental group:LingGuiQiHua Granule
Control group:LingGuiQiHua Granule Simulator
Sponsors
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 40-80 years, with at least one of the following cardiovascular risk factors: a. History of hypertension (medicated or sustained elevated blood pressure for more than one month). b. History of coronary artery disease. 2. BNP > 35 pg/ml or NT-proBNP > 125 pg/ml. 3. Echocardiographic assessment reflect that left ventricular ejection fraction (LVEF) =50% (no previous record below 50%), with at least one of the following alterations: a. Left Atrial Volume Index (LAVI) > 28 mL/m^2. b. Left ventricular wall thickness = 12 mm. c. E/E’ ratio > 8. d. Left Ventricular Mass Index > 115/95 g/m^2 (male/female). 4. Traditional Chinese Medicine (TCM) diagnosis consistent with the pattern of 'impediment of heart and lung qi leading to internal retention of phlegm and fluid'. 5. Voluntary consent to participate, as evidenced by signing an informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of heart failure or presence of any overt heart failure symptoms 2. Persistent atrial fibrillation. 3. Hemodynamically significant mitral and/or aortic valve disease. 4. Hemodynamically significant left-sided obstructive lesions, including aortic stenosis. 5. Liver dysfunction (AST or ALT levels exceeding 1.5 times the upper limit). 6. Severe renal impairment (eGFR < 30 mL/min/1.73 m²). 7. Malignancy or any other condition with an expected lifespan of less than 2 years. 8. Pregnant or breastfeeding women. 9. Patients with absolute Contraindication and relative Contraindication of 6-minute walk test 10.Participants in any other interventional clinical study within one month prior to enrollment 11.Individuals with a predisposition to allergies or known allergies to the components of the study drug 12. Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of the study drug, including but not limited to: a.History of major gastrointestinal surgery, such as gastrectomy, gastroenterostomy, or bowel resection; b.History of inflammatory bowel disease within one year prior to enrollment; c.History of pancreatic injury or pancreatitis; d.History of hepatic encephalopathy or esophageal varices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left Atrial Volume index;E/e’;Laboratory tests: complete blood count, urinalysis, serum electrolytes, liver and kidney function tests, coagulation function tests, and pregnancy tests for women of childbearing age; | — |
Secondary
| Measure | Time frame |
|---|---|
| six minutes walk test;Kansas City Cardiomyopathy Questionnaire;Other indicators reflecting cardiac diastolic function, such as left atrial diameter, interventricular septal thickness, left ventricular mass index etc.;NT-proBNP;Traditional Chinese Medicine Syndrome Score Scale;Changes in the gut microbiota structure;Epicardial adipose tissue area;adverse events and adverse reactions; | — |
Countries
China
Contacts
Public ContactDong Guoju
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Outcome results
None listed