Heart failure
Conditions
Interventions
Gold Standard:Western medical diagnostic criteria: Refer to the diagnostic criteria for heart failure in the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024". The diagnostic
Index test:A digital and intelligent traditional Chinese medicine olfactory diagnosis method based on the enrichment technology of aldehyde and ketone volatile organic compounds in exhaled breath and
Sponsors
Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for the Case Group: 1. Meeting the diagnostic criteria for heart failure as outlined in the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024; 2.Meeting the diagnostic criteria specified in the Guidelines for the Diagnosis and Treatment of Chronic Heart Failure in Traditional Chinese Medicine (2022); 3.No restriction on gender; age between 30 and 85 years; 4.The patient is informed and provides consent, voluntarily signing the informed consent form; 5. Able to understand and cooperate with the study procedures, with good compliance, and able to cooperate for three breath collections. Inclusion Criteria for the Healthy Control Group: 1. No restriction on gender; age between 30 and 85 years, with no history of smoking in the past two weeks; 2. No respiratory symptoms (e.g., cough, expectoration, hemoptysis, shortness of breath, dyspnea, or chest pain); 3.Able to understand and cooperate with the study procedures, with good compliance, and able to cooperate for three breath collections; 4.The individual is informed and provides consent, voluntarily signing the informed consent form; 5. No significant diseases affecting daily life and work in the circulatory, nervous, digestive, respiratory, immune, musculoskeletal, urinary, or reproductive systems. This includes any severe chronic diseases, malignant diseases, or mental disorders deemed by a physician to significantly interfere with the information collection for this project, such as severe hepatic or renal insufficiency, malignant tumors, severe anxiety, depression, etc. Healthy individuals may include stable populations such as healthcare workers, students, or individuals undergoing routine physical examinations. Data from healthy controls in other disease studies conducted in the same region may be shared and utilized.
Exclusion criteria
Exclusion criteria: 1. Comorbid conditions including cardiogenic shock, acute myocarditis, uncontrolled malignant arrhythmia, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, severe valvular heart disease requiring surgical intervention, and pulmonary embolism; 2. Recent occurrence of non-cardiac diseases that may affect exercise capacity, or presence of any disease that may be exacerbated by exercise (e.g., infection, hepatic or renal failure, thyrotoxicosis, etc.); 3. Hospitalization for acute exacerbation of heart failure within the past 4 weeks, or New York Heart Association (NYHA) functional class IV; 4. Presence of any chronic disease that may affect the exhaled breath metabolome (e.g., uncontrolled diabetes, thyroid dysfunction, chronic liver disease, chronic kidney disease); 5. Hepatic transaminase (ALT or AST) levels exceeding 3 times the upper limit of normal due to non-heart failure causes, estimated glomerular filtration rate (eGFR) 5.5 mmol/L; 6. Comorbid severe primary diseases of the liver, kidney, hematopoietic system, nervous system, endocrine system, etc.; patients with tumors; and patients with mental disorders; 7.Comorbid metabolic diseases, such as diabetic ketoacidosis; 8.Presence of autoimmune diseases, such as systemic lupus erythematosus or rheumatoid arthritis; 9. Women who are planning pregnancy, are pregnant, or are lactating; 10.Suspected or confirmed alcohol or substance abuse; 11. Inability to cooperate for three breath collections due to other reasons; 12. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and Specificity of the Model; | — |
Secondary
| Measure | Time frame |
|---|---|
| Composition and Concentration of Volatile Organic Compounds in Exhaled Breath;General Demographic Information (Initials, Medical Record Number, Collection Time, Date of Birth, Age, Sex, Height, Weight, Body Temperature, Blood Pressure, Pulse Rate, Respiratory Rate);Basic Medical History and Diagnosis (Etiological Factors, Season of Onset, Smoking and Alcohol History, Body Temperature, Heart Rate, Blood Pressure, Respiratory Rate, NYHA Functional Class, Past Medical History, Drug Allergy History, Family History);Symptoms and Physical Signs (Chest Pain, Chest Tightness, Palpitations, Dyspnea, Lower Limb Edema, Dizziness, Headache, Tongue Appearance, Pulse Quality, TCM Syndrome Elements, TCM Syndrome Type, Dyspnea VAS Score, Severity of Bilateral Lower Limb Edema, NYHA Functional Class);Laboratory Parameters (Creatine Kinase MB Isoenzyme CK-MB, Cardiac Troponin cTnI/T, NT-proBNP, Urinalysis, Complete Blood Count, Biochemistry Panel, Coagulation Function, Electrocardiogram, Echocardiography, High-Sensitivity Troponin T hs-cTnT, Fasting Glucose Glu, Low-Density Lipoprotein Cholesterol LDL-C, Estimated Glomerular Filtration Rate eGFR, Body Mass Index BMI); | — |
Countries
China
Contacts
Public ContactZhong Rui, Zhang Mei
Beijing University of Chinese Medicine
Outcome results
None listed