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Observational Safety study of Short-term Use of Colchicine on inhibiting pro-Inflammatory cytokines in Patients with Heart Failure with Preserved Ejection Fraction

Observational Safety study of Short-term Use of Colchicine on inhibiting pro-Inflammatory cytokines in Patients with Heart Failure with Preserved Ejection Fraction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500103522
Enrollment
Unknown
Registered
2025-05-30
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Ejection fraction preserving heart failure

Interventions

Colchicine treatment group:NA

Sponsors

The First Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Meet one of the following criteria: Meet the clinical diagnostic criteria for HFpEF in the ESC guidelines for the diagnosis and treatment management of acute and chronic heart failure; Gold standard: Undergo left heart catheterization and be diagnosed with HFpEF. The diagnostic criteria are LVED >=15 mmHg, or when 10 mmHg =19 mmHg. The straight leg raising test can effectively differentiate occult HFpEF, with a specificity of 100% in diagnosing occult HFpEF and without interference from the use of diuretics by the patient. Elevation of one or more inflammatory factors (IL-6, IL-8, TNF-a).

Exclusion criteria

Exclusion criteria: 1. Echocardiography indicates an ejection fraction of less than 50% (currently or previously); 2. Patients under the age of 18 years; 3. Patients with myocardial ischemia due to coronary artery stenosis requiring further interventional treatment; 4. Patients with abnormal liver or kidney function, eGFR = 60%, AST or ALT > 3 times the normal value; 5. Patients with respiratory diseases, congenital heart disease, significant valvular heart disease (more than mild stenosis, more than moderate regurgitation), pulmonary hypertension, constrictive pericarditis, primary cardiomyopathy, or cardiac transplantation; patients with severe infections, malignant tumors, or an expected survival of less than one month; 6. Patients with other indications for colchicine treatment or a history of intolerance to colchicine; 7. Other reasons or deemed unsuitable for this trial by the investigators.

Design outcomes

Primary

MeasureTime frame
Interleukin 1ß;Interleukin 2;Interleukin 5;Interleukin 6;Interleukin 8;Interleukin 10;Interleukin 4;Tumor necrosis factor a;

Secondary

MeasureTime frame
Hamilton anxiety scale (HAMA);Hamilton depression scale (HAMD);Kansas City Cardiomyopathy Patients Quality of Life Scale (KCCQ);Liver function;renal function;Blood routine examination;

Countries

China

Contacts

Public ContactLiu Chao

The First Hospital of Hebei Medical University

dr.liuchao@hotmail.com+86 186 3388 9667

Outcome results

None listed

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