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Colchicine in Patients with Heart Failure with Preserved Ejection Fraction and Inflammation | Clinical Trials | Clareo Health

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Colchicine in Patients with Heart Failure with Preserved Ejection Fraction and Inflammation

Efficacy and Safety of Colchicine in Patients with Heart Failure with Preserved Ejection Fraction and Inflammation

NCT06604611•Dongying Zhang

View on ClinicalTrials.gov

Summary

The main purpose of the CHIPS trial is to evaluate the efficacy and safety of colchicine in heart failure with preserved ejection fraction (HFpEF) patients with inflammation, including the effects of colchicine on circulating inflammatory markers, cardiac structure, cardiac function, clinical symptoms and exercise capacity in HFpEF patients.

Detailed Description

HFpEF is a disease with complex pathophysiological mechanisms, and inflammation has been found to be strongly associated with the onset and progression of HFpEF. Anti-inflammatory treatments begin to cut a striking figure in cardiovascular disease therapy. The LoDoCo2 trial showed a significant prognostic improvement of colchicine in patients with chronic coronary artery disease, and the latest COLICA trial, showed that 8 weeks of colchicine treatment significantly reduced levels of circulating inflammatory markers in patients with decompensated heart failure without serious adverse effects. However, at present, the efficacy and safety of colchicine for the treatment of HFpEF remains unclear. The CHIPS trial is a multi-center, randomized, open-label clinical trial. The aim of the study is to evaluate the efficacy and safety of colchicine in patients with heart failure with preserved ejection fraction and inflammation. The investigators proposed to assess changes in KCCQ scores, NT-proBNP levels, echocardiography and plasma inflammatory marker levels in HFpEF patients treated with or without colchicine to evaluate the efficacy of colchicine in HFpEF treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Left ventricular ejection fraction measured by echocardiography ≥ 50%
•Objective evidence of structural of functional abnormalities measured by echocardiography: 1)LVMI≥95 g/m2 in female and ≥115 g/m2 in male or 2)LAVI greater than 29ml/m2 in sinus rhythm or greater than 40ml/m2 in atrial fibrillation or 3)Average E/e' greater than 14 or 4)TR velocity greater than 2.8 m/s
•Patients with elevated NT-proBNP levels 24 hours after discontinuing intravenous diuretics: ≥300 pg/ml in patients with sinus heart rate; ≥600 pg/ml in patients with atrial fibrillation
•Both outpatient and admitted patients can be considered for enrollment. All patients must occurred worsening heart failure event within 30 days prior to randomization and a current NYHA cardiac function class II-IV
•Patients with CRP levels greater than 2mg/L
•Patient agrees to join and signs a written informed consent form

Exclusion Criteria

•Received colchicine treatment within one month prior to randomization
•Acute coronary syndrome within 3 months prior to randomization, or history of pacemaker implantation, PCI, CABG within 3 months
•eGFR less than 25 mL/min/1.73 m2
•Liver function Child-Pugh class B or C
•Patient has a history of previous allergy to colchicine or dapagliflozin / empagliflozin
•Heart failure due to the following reasons: pericardial disease, pericardial effusion, myocarditis, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and other rare cardiomyopathies such as Fabry disease
•Combined diagnosis of gastric ulcer, ulcerative colitis, Crohn disease and other digestive disorders or combined gastrointestinal tumors
•Plan to undergo cardiac surgery such as coronary revascularization, radiofrequency ablation of arrhythmias, valve replacement or other surgical procedures
•Pregnant or breastfeeding women
•The patient who is cognitively impaired and is unable to accurately complete the assessment and completion of the KCCQ scale with the assistance of a physician
+5 more criteria

Locations (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

October 31, 2024

Primary Completion Date

December 31, 2025

Completion Date

March 31, 2026

Last Updated

September 19, 2024

Enrollment

200

ESTIMATED participants

Conditions

Heart FailureHeart Failure with Preserved Ejection Fraction (HFPEF)Chronic InflammationInflammationColchicine

Interventions

Colchicine 0.5 MG Oral Tablet Once Daily

DRUG

Contacts

Junlong Chen, MD.

CONTACT

86-15111871817 junlongchen2024@163.com

Lei Gao, MD.

CONTACT

86-15123908507 653161583@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Colchicine in Patients with Heart Failure with Preserved Ejection Fraction and Inflammation

Inclusion Criteria

Exclusion Criteria

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