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NOT YET RECRUITING
NCT07841275

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

View on ClinicalTrials.gov

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

DRUG

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