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The clinical trial of randomised, controlled, open, single-centre assessment of colchicine treament on vulnerable stage heart failure patients

The clinical trial of randomised, controlled, open, single-centre assessment of colchicine treament on vulnerable stage heart failure patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043908
Enrollment
Unknown
Registered
2021-03-05
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-07-05

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

Conditions

heart failure

Interventions

treatment group:colchicine
control group:standardized drug treatment

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with chronic heart failure(NYHA II-IV),ejection fraction =18,<80,admission because of acute decompensation of heart faiure or within 3 months of discharge: 1) Sign the written informed consent to participate in the trial. 2) Men or women aged 18 years or older and less than 80 years on the day of signing informed consent; 3) History of chronic heart failure (NYHA class II-IV), receiving standard drug therapy before heart failure decompensation; 4) Left ventricular ejection fraction < 40% measured by echocardiography within the first 12 months (the most recent measurement must be used to determine eligibility); 5) Meet one of the following criteria: A) Subject is male. B) The subject is not a woman of childbearing potential or C) the subject is a woman of childbearing potential but agrees to take contraceptive measures throughout the study.

Exclusion criteria

Exclusion criteria: 1) Cardiogenic shock; 2) Hemodynamic instability; 3) Patients with significant bleeding tendency or hematological diseases, or patients with bone marrow suppression; 4) bronchial asthma, severe obstructive pulmonary disease; 5) Patients with severe renal insufficiency (eGFR < 30ml/min/1.73 m2), or only one kidney or kidney transplant patients; 6) Patients with severe liver dysfunction (Child-Pugh class B or C); 7) Patients with severe gastrointestinal diseases, such as gastrointestinal malignancies, recurrent gastrointestinal ulcers, and severe elimination History of chemical tract bleeding, severe diarrhea in recent one month, etc.; 8) Patients with acute myocardial infarction in the past three months; 9) Patients with severe immune system diseases or gout, in the treatment of steroidal anti-inflammatory drugs, cytotoxic drugs or colchicine; 10) Taking strong CYP3A4 inhibitors (such as atazanavir, itraconazole, clarithromycin, thiazepam, etc.) or P-gp inhibitors (such as verapamil, erythromycin, cyclosporine, quinidine, propafenone, etc.); 11) Pregnant women, lactating or planning to become pregnant; 12) Acute or severe systemic infection; 13) Subjects are participating in clinical trials of other drugs or medical devices; 14) Any known drug or alcohol dependence, difficulty understanding the trial protocol, unable or follow up according to the trial protocol; 15) Patients who the investigators believe are not suitable for this trial.

Design outcomes

Primary

MeasureTime frame
Activity to'lerance;ejection fraction;readmission rate;mortality;

Countries

China

Contacts

Public ContactBiao XU

Nanjing Drum Tower Hospital

gurong.nju@163.com+86 13505193257

Outcome results

None listed

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