Colchicine in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction (NCT05637398) | Clinical Trial Compass
CompletedPhase 1/2
Colchicine in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction
Russia42 participantsStarted 2022-12-15
Plain-language summary
Heart failure with preserved left ventricular ejection fraction (HFpEF) is a syndrome associated with high morbidity and mortality rates. Systemic low-grade inflammation is acknowledged to be a fundamental pathophysiological mechanism of HFpEF. Interventions targeting inflammatory pathway is understudied in HFpEF. Colchicine is a safe and well tolerated anti-inflammatory drug, which interferes with several steps in the inflammatory process. The drug has been extensively studied in different cardiovascular pathologies except HFpEF. We assume that colchicine decreases inflammation and reduces sST2 levels in HFpEF.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 40 years of age, male and female
* Left ventricular ejection fraction (LVEF) ≥ 50%
* Symptoms and signs of heart failure
* N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥300 pg/ml at baseline (patients in atrial fibrillation at baseline NT-proBNP ≥ 600 pg/ml), left atrial volume index (LAVI) \>34 mL/m2 or a left ventricular mass index (LVMI) =115 g/m2 for males and =95 g/m2 for females
* body mass index (BMI) \> 30kg/m2 or diabetes mellitus
Exclusion Criteria:
* Hypertrophic cardiomyopathy, constrictive pericarditis, or cardiac amyloidosis
* Acute decompensation of HF in the last 1 month
* Valvular heart disease
* Prior history of LVEF below 50%
* Acute myocardial infarction in the last 3 months, cardiac surgery or cerebrovascular accident within the recent 6 months
* Any active or chronic inflammatory diseases or infections
* Patients with indication for colchicine therapy or history of colchicine intolerance
* Severe hepatic (alanine aminotransferase N3 upper limit of normal or renal dysfunction (estimated glomerular filtration rate \<45 mL/min per 1.73m2)
* Severe nervous system diseases
* History of any malignancy or suffering from cancer
* Lack of informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Soluble suppression of tumourigenicity 2 (sST2,ng/ml)
Timeframe: from baseline to 12 weeks of treatment
2
2. Change in high-sensitivity C-reactive protein (hsCRP, mg/l )
Timeframe: Time Frame: from baseline to 12 weeks of treatment
Trial details
NCT IDNCT05637398
SponsorI.M. Sechenov First Moscow State Medical University