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Real-World Effectiveness and Costs of Yiqi Fumai Lyophilized Injection in Coronary Heart Disease-Related Chronic Heart Failure
Sponsor: China Academy of Chinese Medical Sciences
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.
Official title: A Two-Center Retrospective Comparative Cohort Study and Pharmacoeconomic Evaluation of Yiqi Fumai Lyophilized Injection in Coronary Heart Disease-Related Heart Failure With Reduced Ejection Fraction, NYHA Class II or III, and Qi and Yin Deficiency Syndrome
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2026-09
Completion Date
2026-12
Last Updated
2026-09-25
Healthy Volunteers
No
Interventions
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.
Locations (2)
Guang'anmen Hospital Jinan Hospital, China Academy of Chinese Medical Sciences
Jinan, Shandong, China
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China