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Colchicine in HFpEF | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Colchicine in HFpEF

A Biomarker Study Assessing the Effects of Colchicine on Inflammation and Extra-Cellular Matrix Turnover in Patients With Heart Failure and Preserved Ejection Fraction.

NCT04857931•Montreal Heart Institute

View on ClinicalTrials.gov

Summary

Heart failure is a growing epidemic that affects up to 500,000 individuals in Canada, with 50,000 new cases being diagnosed each year. Half of these will have HF with preserved ejection fraction (HFpEF). HFpEF has been associated with high rates of morbidity, mortality, and health care expenditures. Its pathophysiology remains poorly understood, and positive medication trial results to date have been rare. Inflammation is strongly associated with a profibrotic activation in HFpEF, which is in turn associated with the severity and prognosis of the disease. Colchicine is a potent anti-inflammatory drug which properties relate to the suppression of tubulin polymerization and inflammasome inhibition, thus reducing the production of IL-1β and IL-18. The investigators thus propose a pilot study of 6 months follow-up duration that will test the efficacy and safety of 2 dosing regimens of colchicine (vs. placebo) in patients with HFpEF.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients ≥ 40 years of age;
•Chronic symptomatic HFpEF defined as follows: left ventricular ejection fraction (LVEF) \> or = 45% within 6 months prior to screening visit (regardless of the imaging modality);
•No recent change in RAAS inhibitors regimen for at least 1 month before enrolment (excluding changes in oral diuretics);
•NYHA functional class II to IV;
•Evidence of structural heart disease defined by at least 1 of the following echocardiography findings: LV hypertrophy (i.e. septal or posterior wall thickness ≥1.1 cm) or left atrial enlargement (i.e., width ≥3.8 cm, length ≥5.0 cm, area ≥20 cm2, volume ≥55 ml, or volume index ≥29 ml/m2);
•Patients with a diagnosis of acute heart failure (treated with intravenous diuretics) within 12 months before screening; or an NT-proBNP of ≥300 pg/ml if in sinus rhythm, and ≥900 pg/ml if in atrial fibrillation within 30 days before screening (if multiple measurements, consider the highest);
•At least one of the following criteria defining chronic enhanced inflammatory milieu:
•1. Obesity, defined as body mass index (BMI) \> 30kg/m2,
•2. Type 2 diabetes according to Diabetes Canada definition (http://guidelines.diabetes.ca/cpg/chapter3), and regardless of therapy,
•3. Evidence of pathological systemic inflammation including: high hs-CRP levels (hs-CRP\>2mg/L), or the combination of high neutrophil count and low lymphocyte count (Neutrophil to Lymphocyte Ratio \>3) within 30 days before screening (if multiple measurements, consider the higher),
+1 more criteria

Exclusion Criteria

•Any prior measurement of LVEF \<40%;
•Patients with a diagnosis of hypertrophic or infiltrative cardiomyopathy;
•Presence of hemodynamically significant valvular heart disease in the opinion of the investigator;
•Presence of active infection within the 3 months prior to visit 1 needing antibiotics (excluding COVID-19);
•Acute decompensated HF, acute coronary syndrome (including myocardial infarction), cardiac surgery, other major cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to visit 1;
•Elective PCI within 30 days prior to visit 1;
•Known or clinically judged significant (i.e., angina with CCS class \>2/4) epicardial coronary artery disease (CAD) that has not been revascularized (revascularized CAD is defined by a history of myocardial infraction, percutaneous intervention, or coronary artery bypass grafting);
•Changes renin-angiotensin-aldosterone system (RAAS) inhibitors regimen within 30 days prior to screening visit;
•History of hypersensitivity to colchicine;
•Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or atrial flutter with a resting ventricular rate \>120 beats per minute;
+10 more criteria

Locations (1)

Montreal Heart Institute

Montreal, Quebec, Canada

Key Dates

Start Date

June 17, 2022

Primary Completion Date

March 7, 2023

Completion Date

March 7, 2023

Last Updated

April 26, 2023

Enrollment

ACTUAL participants

Conditions

Heart FailureInflammationColchicine

Interventions

Colchicine

DRUG

Placebo

DRUG

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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: April 26, 2023Data 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.

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Colchicine in HFpEF

Inclusion Criteria

Exclusion Criteria

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