Yiqi Fumai injection and costs in heart failure from coronary heart disease

Trial details

Who runs it

China Academy of Chinese Medical Sciences

Trial code

NCT07841275

Record updated

25 September 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: The index date was from June 1, 2021 through June 1, 2026, the patient received inpatient or systematic clinical care at a participating center, and the patient was 40 to 80 years of age at time zero, with no restriction by sex; The medical record supports protocol-defined coronary heart disease-related chronic left ventricular dysfunction or coronary heart disease with chronic heart failure; The record contains sufficient information on functional class, echocardiography, BNP or NT-proBNP, medications, treatment course, laboratory tests, direct medical costs for the index hospitalization, heart-failure-related rehospitalization through 90 days, death, and follow-up for the prespecified analyses; Qi and Yin deficiency syndrome or a related Qi-and-Yin-deficiency pattern can be determined from the medical record according to the prespecified adjudication rules; The record is eligible for research use under ethics and data-governance requirements and can be de-identified before analysis; a waiver of informed consent must be documented when applicable; The index date, first treatment date and time, daily and cumulative dose, treatment duration, discontinuation, completion, and crossover can be verified when Yiqi Fumai lyophilized injection was used; Time zero, eligibility, and baseline variables can be reliably reconstructed, and initiation or non-initiation of Yiqi Fumai lyophilized injection within 24 hours after time zero can be clearly classified; Prespecified baseline covariates can be abstracted, including age, sex, body mass index, history and grade of hypertension, cardiovascular risk, smoking, alcohol use, antihypertensive treatment, NYHA class, LVEF, BNP or NT-proBNP, heart-failure duration, comorbidities, guideline-directed medical therapy, diuretic intensity, baseline cost, and study center; Acute conditions after time zero, treatment crossover, rescue treatment, and documented Chinese medicines or nonpharmacologic traditional Chinese medicine therapies, including their indication and start and stop dates, can be abstracted. Post-baseline variables will not be included in the baseline propensity-score model.

Exclusion: Time zero cannot be reliably reconstructed, or initiation or non-initiation of Yiqi Fumai lyophilized injection within 24 hours after time zero cannot be clearly classified. Otherwise, patients will not be excluded from the primary analysis solely because subsequent treatment lasted less than 7 days, a 10-day course was not completed, treatment was discontinued, or crossover occurred. Patients who initiated the drug after 24 hours remain assigned to the non-initiation strategy in the primary intention-to-treat analogue; Evidence supporting coronary heart disease is insufficient, or heart failure is caused primarily by a noncoronary condition; Acute myocardial infarction, acute coronary syndrome, cardiogenic shock, or another critical illness dominates the index episode; Critical diagnostic, index, exposure, outcome, or cost information is missing to an extent that prevents eligibility classification or the prespecified analysis; Another Qi-tonifying and Yin-nourishing Chinese medicine injection, decoction, or proprietary Chinese medicine with overlapping effects was used during the relevant treatment period and its contribution cannot be distinguished; The record is a duplicate treatment episode. For a patient with multiple eligible episodes, only the first eligible index hospitalization will be retained for the primary analysis.

ClinicalTrials.gov NCT07841275