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Evaluation of the efficacy and safety of the injection product "Qi-yi Fu-mai (lyophilized)" under the guidance of CPET for patients with heart failure with preserved ejection fraction

Evaluation of the efficacy and safety of injectable Yiqi Fumai (freeze-dried) under the guidance of CPET for heart failure with preserved ejection fraction

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001793
Enrollment
Unknown
Registered
2025-09-21
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with preserved ejection fraction

Interventions

Observation group:Conventional Western medicine treatment + Yiqi Fumai for Injection (lyophilized)
Control group:Conventional Western medicine treatment for heart failure with preserved ejection fraction

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: (1) It meets the diagnostic criteria for chronic heart failure in Western medicine and is classified as grade II-III by NYHA. (2) It meets the diagnostic criteria for heart failure in traditional Chinese medicine and the syndrome belongs to deficiency of both qi and Yin. (3) Age: 18-79 years old gender not limited; (4) Agree to the treatment plan and sign the informed consent form;

Exclusion criteria

Exclusion criteria: (1) Those whose palpitations shortness of breath and limb edema are verified to be caused by acute heart failure or other heart diseases etc. (2) Those with concurrent lumbar intervertebral disc protrusion severe osteoporosis gout and other diseases that may affect exercise endurance; (3) Those with severe heart diseases such as acute myocardial infarction severe arrhythmia severe cardiac insufficiency severe valvular disease and aortic dissection; (4) Those with poorly controlled severe hypertension (systolic blood pressure >180mmHg and/or diastolic blood pressure >100mmHg) or hypertensive emergencies or subacute hypertension; (5) Those with concurrent acute pulmonary edema pulmonary embolism severe upper respiratory tract infectious diseases or acute hemodynamic disorders; (6) Those with severe primary diseases or malignant tumors of the liver kidneys endocrine system and hematopoietic system etc. (7) Those with intellectual disabilities (such as cognitive impairments) and mental disorders; (8) Those who have recently experienced cerebrovascular accidents major surgeries or trauma; (9) Pregnant or lactating women; (10) People with allergic constitutions and those allergic to the drug components used in the treatment process; (11) Those with communication or cognitive impairments who are unable to provide relevant materials or do not cooperate;

Design outcomes

Primary

MeasureTime frame
Peak oxygen uptake;Anaerobic threshold;

Secondary

MeasureTime frame
NYHA Cardiac Function Classification;NT-proBNP level;Echocardiography;Carbon dioxide ventilation equivalent slope (VE/VCO2 slope);Percentage of peak oxygen uptake relative to predicted value (peak VO2%pred);6-minute walk test;Electrocardiogram;X-ray chest film;Blood routine test;Urinalysis;Thyroid function;Liver and kidney functions;Cardiac failure syndrome score in traditional Chinese medicine;Minnesota Health Handicap Questionnaire (MLHFQ);

Countries

China

Contacts

Public ContactJie Yang

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

sumuzheyangjie@163.com13608935839

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026