heart failure with preserved ejection fraction
Conditions
Interventions
HFpEF Group:No intervention (observational study)
Cardiovascular High-Risk Control Group:No intervention (observational study)
Sponsors
Nanjing Jiangning Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for the HFpEF Group Western Medicine Diagnostic Criteria (Diagnosis established following the outlined in the 2023 Expert Consensus on Heart Failure with Preserved Ejection Fraction, requiring criterion 2) plus either 3) or 4)): 1) Presence of heart failure symptoms (e.g., dyspnea, fatigue, edema) and/or signs. 2) Left ventricular ejection fraction (LVEF) = 50%. 3) Elevated natriuretic peptide levels (meeting any of the following): Sinus rhythm: BNP = 35 pg/mL or NT-proBNP = 125 pg/mL. Atrial fibrillation: BNP = 105 pg/mL or NT-proBNP = 365 pg/mL. 4) Objective evidence of structural or functional cardiac abnormalities (at least one of the following; the first item carries the highest diagnostic value): Tissue Doppler-derived E/e' = 15. Peak tricuspid regurgitation velocity > 3.4 m/s. Echocardiographic left atrial volume index (LAVI) > 34 mL/m². Increased left ventricular wall thickness (LVWT). Traditional Chinese Medicine Syndrome Differentiation Criteria for the HFpEF Group Based on established standards including the Guiding Principles for Clinical Research of New Chinese Medicines, the Guidelines for Traditional Chinese Medicine Diagnosis and Treatment of Chronic Heart Failure, and the Traditional Chinese Medicine Syndrome Score Scale for Heart Failure, the diagnostic criteria for "Qi Deficiency and Blood Stasis Syndrome" are defined as follows: Primary symptoms: 1) Palpitations and chest tightness; 2) Shortness of breath and fatigue. Secondary symptoms: 1) Pale or darkish complexion; 2) Light purple tongue or tongue with petechiae/ecchymosis; 3) Weak or uneven pulse. Diagnosis: A diagnosis of Qi Deficiency and Blood Stasis Syndrome requires the presence of all primary symptoms and at least two secondary symptoms. Syndrome diagnosis for all patients must be independently determined by at least two physicians with associate senior professional titles or higher in Traditional Chinese Medicine. In case of disagreement, consensus shall be reached through discussion, or adjudication by a third expert shall be sought. Inclusion Criteria for the Cardiovascular High-Risk Control Group 1) Patients aged 50-80 years with well-controlled hypertension, type 2 diabetes mellitus (without severe complications), or hyperlipidemia. 2) No clinical history of heart failure, coronary heart disease, cardiomyopathy, significant valvular heart disease, stroke, or peripheral arterial disease. 3) Echocardiography demonstrating left ventricular ejection fraction (LVEF) > 55%, with no evidence of structural heart disease such as left ventricular hypertrophy or left atrial enlargement. 4) NT-proBNP levels within the normal reference range for the corresponding age.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (Participants meeting any of the following criteria will be excluded) 1) Complicated by severe liver, kidney, or hematopoietic system diseases, or malignant tumors. 2) Pregnant or lactating women. 3) Mental illness or inability to cooperate in completing questionnaires and follow-up assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procollagen Type I C-Terminal Propeptide;Procollagen Type III N-Terminal Peptide;Cross-Linked C-Telopeptide of Type I Collagen;Lysyl Oxidase;Matrix Metalloproteinase-9;Matrix Metalloproteinase-14;Transforming Growth Factor-Beta;Fetuin-A; | — |
Secondary
| Measure | Time frame |
|---|---|
| Coronary Artery Calcium Score (CACS);Traditional Chinese Medicine Qi Deficiency and Blood Stasis Syndrome Score; | — |
Countries
China
Contacts
Public ContactJiayang Xu
Nanjing Jiangning Hospital of Traditional Chinese Medicine
Outcome results
None listed