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Assessment of Complementary Treatment with Yiqi Fumai Lyophilized Injection on Acute Decompensated Ischemic Heart Failure: a Multicenter, Randomized, Controlled Trial

Study on the efficacy of interventions for chronic heart failure syndroms

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007396
Enrollment
Unknown
Registered
2015-11-04
Start date
2015-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Ischemic heart failure

Interventions

treatment group:Standard Western treatment plus 5.2g Yiqi Fumai Lyophilized Injection in 5% GS or NS injection 250ml,60ml/h ivdrip,qd.
control group:Regular Western medication

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Aged 40 to 79; 2. Patients with coronary heart disease; 3. Patients with acute decompensated chronic heart failure; 4. Cardiac function classification: New York Heart Association (NYHA) III to IV; 5. Those whose Brain Natriuretic Peptide(BNP)>200pg/mL; 6. Patients with Qi-yin deficiency syndrome; 7. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who suffer from acute heart failure on initial diagnosis; 2. Those who have one of the following diseases: 1) Acute coronary syndrome; 2) Hypotension (systolic blood pressure=180mmHg and/or diastolic blood pressure>=110mmHg); 5) Degree II typeII or severe sinoatrial or atrioventricular block without pacemaker implantation, uncontrolled malignant arrhythmia; 6) Severe valve disease; 7) Dilated cardiomyopathy; 8) Hypertrophic obstructive cardiomyopathy; 9) Myocarditis; 10) Pulmonary embolism; 11) Pulmonary heart disease; 12) Stroke within 6 months; 3. Preparation for revascularization or cardiac resynchronization therapy (CRT) within 2 months; 4. Alanine aminotransferase(ALT)>3 times the upper limit of normal; 5. Serum creatinine>2 times the upper limit of normal; 6. Severe endocrine diseases such as hyperthyroidism, etc; 7. Hemoglobin(HB)<=9g/dl; 8. Mental disorder; 9. History of malignant tumor; 10. Being pregnant, planning for pregnancy or breastfeeding; 11. Suspicious or definite allergy to intervention drugs; 12. Participated in other trials within 2 months.

Design outcomes

Primary

MeasureTime frame
Brain natriuretic peptide (BNP);

Secondary

MeasureTime frame
Composite endpoint: including all-cause mortality, HF emergency/re -admission, acute coronary syndrome, revascularization, serious cardiac arrhythmias, cardiac shock, stroke, pulmonary embolism;Echocardiography(LVEF,etc);Blood troponin (TNT/TNI);Cardiothoracic Ratio(CR);Life quality scale;Scores from the four TCM diagnostic methods;

Countries

China

Contacts

Public ContactJingyuan Mao
jymao@126.com+86 022-27432019

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 6, 2026