Evaluation of cardiometabolic factors in heart failure patients
Cardiometabolic Risk Factors and Clinical Outcomes in Heart Failure: An Observational Cohort Study
This study looks at how different health factors related to metabolism and body fat affect heart function and outcomes in people with heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06939985 on ClinicalTrials.gov |
What this trial studies
This observational cohort study investigates the impact of systemic and local cardiometabolic risk factors on cardiac remodeling and clinical outcomes in heart failure patients. It combines retrospective clinical data from the past decade with a 5-year prospective follow-up, examining various heart failure phenotypes including HFrEF, HFmrEF, HFpEF, and HFimpEF. The study analyzes metabolic factors such as blood lipid profiles and insulin resistance, alongside localized factors like epicardial and perivascular adipose tissue, to understand their associations with cardiac function and adverse cardiovascular events.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic heart failure across various ejection fraction phenotypes.
Not a fit: Patients with an estimated survival of less than one year or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance risk stratification and management strategies for heart failure patients.
How similar studies have performed: Other studies have shown success in evaluating cardiometabolic factors in heart failure, but this study's comprehensive approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Chronic HF (NYHA II\~IV), including: * HFrEF (HF with reduced ejection fraction): ① HF symptoms±signs ; ② LVEF≤40%. * HFimpEF (HF with improved ejection fraction): ① HF symptoms±signs; ② previous LVEF ≤ 40% and a follow-up measurement of LVEF \>40%. * HFmrEF (HF with mildly reduced ejection fraction): ① HF symptoms±signs; ② LVEF 41%\~49%. * HFpEF (HF with preserved ejection fraction): ① HF symptoms±signs; ② LVEF ≥50%; ③ objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures, including raised natriuretic peptide. Exclusion Criteria: 1. Estimated survival ≤ 1 year. 2. Pregnant or lactation, or have the intention to give birth within one year. 3. Poor compliance, unable to follow-up. 4. Mental or physical status not allowing written informed consent. 5. Unwillingness to give informed consent.
Where this trial is running
Shanghai
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Ruiyan Zhang, M.D., Ph.D. — Ruijin Hospital
- Study coordinator: Chendie Yang, M.D., Ph.D.
- Email: yangcd1029@163.com
- Phone: 0086-21-64370045-671503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.