- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07619222
Correlation and Prognostic Value of Body Composition, Cardiac Structure and Function in Patients With Different Heart Failure Subtypes
Study on the Correlation and Prognostic Value of Body Composition, Cardiac Structure and Function in Patients With Different Subtypes of Heart Failure
Heart failure (HF) refers to impaired cardiac function caused by various heart diseases. Patients commonly present with dyspnea, fatigue, edema and other symptoms, ranking among the leading causes of death from cardiovascular diseases worldwide. According to World Health Organization statistics, more than 26 million people globally suffer from heart failure. The rising prevalence of aging population, hypertension, diabetes and other comorbidities continues to expand the patient population, imposing a heavy burden on families and society.
Body mass index (BMI) was traditionally adopted to assess the correlation between obesity and heart failure, yet this method has inherent limitations. The obesity paradox indicates that obese heart failure patients may achieve better recovery outcomes than those with normal weight. Additionally, BMI fails to differentiate the impacts of adipose tissues distributed in distinct anatomical sites. Advances in imaging technology have enabled accurate quantification of regional fat deposits, including epicardial adipose tissue (EAT), subcutaneous adipose tissue (SAT) and intramuscular adipose tissue (IMAT).
Domestic and international studies have verified that fat distribution exerts greater influence than total fat volume. Directly adjacent to the myocardium, EAT may secrete inflammatory mediators and induce myocardial injury. SAT produces protective bioactive substances, while its effects vary across heart failure subtypes and remain inconclusive. IMAT is correlated with reduced physical activity and poor clinical prognosis. Nevertheless, most existing researches focus solely on single-site fat tissue or specific heart failure types. Comprehensive combined analysis of cardiac, somatic and muscular adipose tissues, as well as systematic comparison among diverse heart failure subtypes, remains insufficient.
This study intends to quantify the three types of adipose tissues simultaneously, combined with cardiac structural and functional examinations, to explore their associations with heart failure. The findings are expected to facilitate precise risk stratification and individualized therapeutic strategy formulation for clinicians.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Meeting the diagnostic criteria for heart failure set forth in the 2022 ESC Guidelines: presence of typical symptoms (e.g., dyspnea, fatigue, edema, etc.) and signs (e.g., pulmonary rales, jugular venous distention, third heart sound, etc.) of heart failure;
- Undergoing both coronary computed tomography angiography (CCTA) and non-contrast chest computed tomography (CT), with image quality meeting the requirements for quantitative analysis;
- Age ≥ 18 years, with complete clinical and follow-up data, and ability to cooperate with imaging examinations and follow-up assessments.
Exclusion Criteria:
- Acute myocardial infarction occurring within 3 months prior to the imaging examination;
- Other definite structural heart diseases, including congenital heart disease, myocarditis, pericardial disease, severe valvular heart disease, etc.;
- End-stage organ diseases (hepatic/renal/pulmonary failure, active malignancy);
- Unmeasurable scan images (e.g., due to pericardial effusion or artifacts);
- Incomplete or missing clinical data.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of Major Adverse Cardiovascular Events (MACE)
Time Frame: The follow-up was conducted within one month after data collection was completed.
|
Major adverse cardiovascular events (MACE), defined as the composite endpoint of all-cause death, non-fatal acute myocardial infarction, and non-fatal stroke.
|
The follow-up was conducted within one month after data collection was completed.
|
|
Proportion of Participants Experiencing Major Adverse Cardiovascular Events (MACE)
Time Frame: Follow-up conducted within one month after data collection was completed.
|
Composite endpoint of all-cause death, non-fatal acute myocardial infarction, and non-fatal stroke.
|
Follow-up conducted within one month after data collection was completed.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KS2026087
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