Colchicine in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction

Launched by I.M. SECHENOV FIRST MOSCOW STATE MEDICAL UNIVERSITY · Nov 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called colchicine in patients with a specific type of heart failure known as heart failure with preserved left ventricular ejection fraction (HFpEF). HFpEF is a condition where the heart can pump blood well, but patients still experience heart failure symptoms due to inflammation in the body. The researchers believe that colchicine, which is known to help reduce inflammation, may improve symptoms for these patients. The trial is currently recruiting participants aged 40 and older, who have certain heart function measurements and symptoms of heart failure.

If you join the study, you will be monitored closely to see how your body responds to colchicine. The trial is open to both men and women, but there are some eligibility requirements, such as having a specific level of heart function and certain lab results. Participants will receive information about the study and will need to give their consent to take part. This research could help improve treatments for heart failure in the future, especially for those dealing with inflammation-related issues.

Gender

ALL

Eligibility criteria

• 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