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
Sponsor study identifier
Secondary identifiers
OTHER · Ethics Review Committee, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
OTHER · Parent integrated research project number
observational
200
1 country
2
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 9, 2026
Actual (reported)September 25, 2026
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Total Direct Medical Cost From Time Zero Through the End of the Index Hospitalization
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.
From time zero to discharge from the index hospitalization or in-hospital death, whichever occurs first; an estimated average of 12 days.
Incidence of First Heart-Failure-Related Rehospitalization Within 90 Days
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.
From time zero through Day 90; qualifying rehospitalizations occur after discharge from the index hospitalization
Incidence of First Heart-Failure-Related Rehospitalization Within 30 Days
From discharge from the index hospitalization through Day 30 after time zero
Incidence of Heart-Failure-Related Rehospitalization or All-Cause Death Within 90 Days
From time zero through Day 90
Incidence of All-Cause Death Within 90 Days
From time zero through Day 90
Incidence of Cardiovascular Death Within 90 Days
From time zero through Day 90
Length of the Index Hospitalization
From admission to discharge from the index hospitalization or in-hospital death, whichever occurs first; an estimated average of 12 days.
Total Heart-Failure-Related Direct Medical Cost Through Day 90
From time zero through Day 90
Percent Change in NT-proBNP During the Index Hospitalization
Baseline within 24 hours before time zero to the follow-up assessment from Day 7 through Day 14 after time zero
Change in Left Ventricular Ejection Fraction During the Index Hospitalization
Baseline from 30 days before time zero through time zero to the last assessment from Day 3 after time zero through index discharge
Patients who initiated Yiqi Fumai lyophilized injection within 24 hours after time zero during routine clinical care. Subsequent treatment duration, completion of a 10-day course, discontinuation, and crossover do not alter baseline strategy assignment in the primary intention-to-treat analogue.
Eligible patients who did not initiate Yiqi Fumai lyophilized injection within 24 hours after time zero during routine clinical care. Patients who initiated the drug later remain assigned to this baseline strategy in the primary intention-to-treat analogue and are recorded as treatment crossovers.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients aged 40 to 80 years who received inpatient or systematic clinical care at either participating center with an index date from June 1, 2021 through June 1, 2026; whose records support protocol-defined coronary heart disease-related chronic left ventricular dysfunction or chronic heart failure and Qi and Yin deficiency syndrome; and whose electronic records permit reconstruction of time zero, eligibility, baseline covariates, 24-hour treatment strategy, clinical outcomes, and direct medical costs.
Guang'anmen Hospital Jinan Hospital, China Academy of Chinese Medical Sciences
Jinan, Shandong, 250012, China
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300381, China
Lianxin Wang, PHD
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
First Submitted
September 9, 2026
First Posted
September 25, 2026
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2026
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 25, 2026
Record last verified: 2026-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: