Real-World Effectiveness and Costs of Yiqi Fumai Lyophilized Injection in Coronary Heart Disease-Related Chronic Heart Failure
Condition(s) studied
Investigational drug(s) / intervention(s)
Yiqi Fumai Lyophilized Injection: Exposure is defined by initiation of Yiqi Fumai lyophilized injection within 24 hours after time zero in routine care. The actual preparation, dose, diluent, infusion rate, treatment dates, cumulative dose, cumulative duration, discontinuation reason, completion of a 10-day course, and subsequent crossover will be abstracted when documented. The researchers did not assign treatment.
Study summary
This two-center retrospective cohort study will use de-identified electronic health records from June 1, 2021 through June 1, 2026 to compare patients with coronary heart disease-related chronic left ventricular dysfunction or chronic heart failure and Qi and Yin deficiency syndrome who initiated Yiqi Fumai lyophilized injection within 24 hours after a common time zero with eligible patients who did not initiate the drug within 24 hours. Treatment was determined during routine care and was not assigned by the researchers. The planned cohort includes 200 randomly sampled records, comprising 150 initiators and 50 non-initiators. The primary economic outcome is total direct medical cost during the index hospitalization, and the primary comparative-effectiveness outcome is heart-failure-related rehospitalization within 90 days after time zero. Baseline differences will be addressed primarily using propensity-score overlap weighting.
Eligibility
Primary outcome measure(s)
- Total Direct Medical Cost From Time Zero Through the End of the Index Hospitalization — From time zero to discharge from the index hospitalization or in-hospital death, whichever occurs first; an estimated average of 12 days.
Total direct medical cost incurred from time zero to discharge from the index hospitalization or in-hospital death, whichever occurs first, will be calculated from itemized medical records using quantity multiplied by unit price and standardized to 2026 Chinese yuan. Cost incurred from admission to time zero will be treated as a baseline covariate. Total cost for the complete index hospitalization will be evaluated in a sensitivity analysis. The estimated average is for registration planning and does not truncate observation; every index admission is followed to its actual endpoint. - Incidence of First Heart-Failure-Related Rehospitalization Within 90 Days — From time zero through Day 90; qualifying rehospitalizations occur after discharge from the index hospitalization
The cumulative incidence of the first unplanned rehospitalization after index discharge for which heart failure is the primary diagnosis or there is clearly documented worsening of heart failure will be estimated through 90 days after time zero. Death before rehospitalization will be treated as a competing risk. Adjusted absolute risk, risk difference, relative effect, and 95% confidence intervals will be reported.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Guang'anmen Hospital Jinan Hospital, China Academy of Chinese Medical Sciences | Jinan | Shandong | |
| The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | Tianjin Municipality |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07841275 on ClinicalTrials.gov ↗ ← All trials in China