Chronic Heart FailureNCT07841275
Real-World Effectiveness and Costs of Yiqi Fumai Lyophilized Injection in Coronary Heart Disease-Related Chronic Heart Failure
An observational study of Chronic Heart Failure and Coronary Heart Disease (CHD), run by China Academy of Chinese Medical Sciences at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Heart Failure, Coronary Heart Disease (CHD)
- What is being tested?
- Yiqi Fumai Lyophilized Injection
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2026to Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- Critical diagnostic, index, exposure, outcome, or cost information is missing to an extent that prevents eligibility classification or the prespecified analysis.
- 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.
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Guang'anmen Hospital Jinan Hospital, China Academy of Chinese Medical Sciences
Jinan, Shandong, 250012
Bai Du, Phd, 86-13439689904, dubaidubai@sina.com
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300381
Shichao Lv, Phd, 86-13920127740, 372272027@qq.com
About this study
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
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 the detailed description
This standalone record covers only the retrospective real-world comparative cohort component of a broader integrated research program. Electronic health records with index dates from June 1, 2021 through June 1, 2026 will be obtained from the Jinan and Tianjin study centers. Follow-up information for the retrospective primary outcomes will be ascertained through September 1, 2026. Time zero is the first point at which all verifiable eligibility criteria are met and baseline variables can be reconstructed. The treatment strategies are initiation of Yiqi Fumai lyophilized injection within 24 hours after time zero and no initiation within 24 hours after time zero. Future cumulative treatment duration is not used to define baseline exposure. Patients are not excluded from the primary intention-to-treat analogue solely because treatment subsequently lasted less than 7 days, the 10-day course was not completed, treatment was discontinued, or treatment crossover occurred. Actual dose, duration, discontinuation, completion, and crossover are recorded for adherence descriptions and prespecified per-protocol, landmark, time-dependent, or marginal structural model sensitivity analyses.
The fixed sample includes 200 patients: 150 initiators and 50 non-initiators, with each center contributing 75 initiators and 25 non-initiators. All eligible index hospitalizations will first be enumerated and deduplicated, retaining the first eligible index hospitalization for patients with multiple records. Four sampling strata will then be formed by study center and 24-hour treatment strategy. Simple random sampling without replacement will be performed within each stratum using a prespecified random seed. The screening flow, random seed, and reasons for non-inclusion will be retained.
The two domain-specific primary outcomes are analyzed separately without a joint success criterion, hierarchy, or performance goal. The primary economic outcome is total direct medical cost from time zero through discharge from the index hospitalization or in-hospital death. The primary comparative-effectiveness outcome is the first heart-failure-related rehospitalization within 90 days after time zero and after discharge from the index hospitalization, with death treated as a competing risk. The primary causal estimand is the average treatment effect in the overlap population. Propensity-score overlap weighting will include prespecified baseline covariates measured at or before time zero. Balance, overlap, positivity, extreme weights, and effective sample size will be evaluated. IPTW, matching, outcome regression, time-dependent analyses, marginal structural models, and 72-hour and Day-7 landmark analyses will be used as appropriate in sensitivity analyses.
- Being tested
- Yiqi Fumai Lyophilized Injection
- Keywords
- Yiqi Fumai Lyophilized Injection, Traditional Chinese Medicine, Real-World Evidence, Pharmacoeconomic Evaluation
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yiqi Fumai Lyophilized InjectionDrug
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 group | Role | What they receive |
|---|---|---|
| Yiqi Fumai Initiation Within 24 Hours | 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. Receives: Drug: Yiqi Fumai Lyophilized Injection | |
| No Yiqi Fumai Initiation Within 24 Hours | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From time zero through Day 90; qualifying rehospitalizations occur after discharge from the index hospitalization
Secondary outcomes (7)
Incidence of First Heart-Failure-Related Rehospitalization Within 30 Days
The cumulative incidence of the first unplanned heart-failure-related rehospitalization within 30 days after time zero will be estimated using the same event definition as the 90-day primary comparative-effectiveness outcome, with death treated as a competing risk.
Measured: 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
The proportion of patients with either an unplanned heart-failure-related rehospitalization after index discharge or death from any cause within 90 days after time zero will be reported as a composite supportive outcome. Time to the first component will be used.
Measured: From time zero through Day 90
Incidence of All-Cause Death Within 90 Days
The proportion of patients who died from any cause within 90 days after time zero will be reported. The date and source of death ascertainment will be recorded when available.
Measured: From time zero through Day 90
Incidence of Cardiovascular Death Within 90 Days
The proportion of patients with death classified as cardiovascular in origin within 90 days after time zero will be reported according to the prespecified source hierarchy and adjudication rules.
Measured: From time zero through Day 90
Length of the Index Hospitalization
Length of the index hospitalization will be calculated from recorded admission to discharge or in-hospital death, whichever occurs first, using elapsed hours divided by 24 when timestamps are available. Date-only records will be flagged and handled consistently under the statistical analysis plan. Death is an endpoint rather than a reason to exclude the stay. The complete admission-based measure is descriptive; resource comparisons restricted to the period after time zero are reported separately.
Measured: From admission to discharge from the index hospitalization or in-hospital death, whichever occurs first; an estimated average of 12 days.
Proportion of Patients With ICU or CCU Use During the Index Hospitalization
The proportion of patients with any documented admission to an intensive care unit or coronary care unit during the index hospitalization will be reported.
Measured: From admission to discharge from the index hospitalization or in-hospital death, whichever occurs first; an estimated average of 12 days.
Duration of ICU or CCU Care During the Index Hospitalization
Cumulative time in ICU or CCU during the complete index hospitalization will be calculated in days, summing documented episodes without double-counting overlapping intervals. The primary descriptive denominator is the full cohort; patients with verified no use contribute zero days, whereas unknown use contributes missing data. Results among actual users are reported separately. ICU/CCU time before and after time zero is distinguished. The estimated average of 12 days refers to the observation window, not to expected ICU/CCU duration.
Measured: From admission to discharge from the index hospitalization or in-hospital death, whichever occurs first; an estimated average of 12 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lianxin Wang, China Academy of Chinese Medical Sciences
- Investigators
- Lianxin Wang, PHD, Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841275
- Sponsor's protocol ID
- WFCMS2026008-RWS
- Other IDs
- P26017-PJ17, WFCMS2026008
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No