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

NCT06604611 | Not Yet Recruiting Phase 4

• 1 other identifier: CHIPS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Heart Failure with Preserved Ejection Fraction (HFPEF); Chronic Inflammation; Inflammation; Colchicine

Keywords

Heart Failure; Heart Failure with Preserved Ejection Fraction (HFpEF); Inflammation

Outcome Measures

Primary Outcomes (3)

• Change in KCCQ-CS scores

  Patients were assessed for symptom improvement by Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS)

  Up to 12 weeks

• Change in 6-MWD

  Improvement in patients exercise capacity assessed by 6-minuet walk distance

  Up to 12 weeks

• Change in serum CRP levels

  Change in serum C-reactive protein levels

  Up to 12 weeks

Secondary Outcomes (12)

• Change in serum NT-proBNP levels

  Up to 12 weeks

• Change in serum IL-1β levels

  Up to 12 weeks

• Change in serum IL-6 levels

  Up to 12 weeks

• Change in serum TNF-α levels

  Up to 12 weeks

• Change in cardiac structure

  Up to 12 weeks

Study Arms (2)

Colchicine Treatment Group

EXPERIMENTAL

This group is intended to include 100 patients, all of the patients will be given 5mg of once-daily the colchicine treatment on top of the SGLT2i treatment

Drug: Colchicine 0.5 MG Oral Tablet Once Daily

Control Group

NO INTERVENTION

The group is intended to include 100 patients, all of the patients will be given standard SGLT2i treatment

Interventions

Colchicine 0.5 MG Oral Tablet Once Daily DRUG

The intervention in this study is colchicine, patients randomized to the experimental group will be given oral colchicine 5mg once a day in 12 weeks.

Colchicine Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Autoimmune diseases such as systemic lupus erythematosus, long-term adrenocorticotropic hormone treatment for other diseases such as Schihan syndrome, or need to accept immunosuppressive drugs and monoclonal antibodies such as IL-1 and IL-6
• Patient with combined active solid tumor or hematological malignancy
• Patient comorbidity with other conditions that may be confused with HFpEF symptoms, such as acute exacerbation of COPD
• Admission with a well-defined infection (symptoms or pathogenetic evidence of infection, and leukocytes greater than 10\*109/L)
• Previously diagnosed with HFrEF (initial assessment of LVEF less than 40%) or diagnosed with LVimpEF

Sponsors & Collaborators

• Dongying Zhang: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Related Publications (3)

• Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

  PMID: 35363499 BACKGROUND

• Nidorf SM, Fiolet ATL, Mosterd A, Eikelboom JW, Schut A, Opstal TSJ, The SHK, Xu XF, Ireland MA, Lenderink T, Latchem D, Hoogslag P, Jerzewski A, Nierop P, Whelan A, Hendriks R, Swart H, Schaap J, Kuijper AFM, van Hessen MWJ, Saklani P, Tan I, Thompson AG, Morton A, Judkins C, Bax WA, Dirksen M, Alings M, Hankey GJ, Budgeon CA, Tijssen JGP, Cornel JH, Thompson PL; LoDoCo2 Trial Investigators. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med. 2020 Nov 5;383(19):1838-1847. doi: 10.1056/NEJMoa2021372. Epub 2020 Aug 31.

  PMID: 32865380 BACKGROUND

• Pascual-Figal D, Nunez J, Perez-Martinez MT, Gonzalez-Juanatey JR, Taibo-Urquia M, Llacer-Iborra P, Delgado J, Villar S, Mirabet S, Aimo A, Riquelme-Perez A, Anguita-Sanchez M, Martinez-Selles M, Noguera-Velasco JA, Ibanez B, Bayes-Genis A. Colchicine in acutely decompensated heart failure: the COLICA trial. Eur Heart J. 2024 Dec 1;45(45):4826-4836. doi: 10.1093/eurheartj/ehae538.

  PMID: 39211951 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Inflammation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Dongying Zhang, MD. Ph.D.

  First Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

Junlong Chen, MD.

CONTACT

86-15111871817; junlongchen2024@163.com

Lei Gao, MD.

CONTACT

86-15123908507; 653161583@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: Patients will be randomly 1:1 allocate into either a colchicine-treated group or a blank control group, and patients included in different centers will be uniformly randomized by the main centre.

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 19, 2024
• Study Start: October 31, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)