Colchicine in Acutely Decompensated HFREF

Launched by UNIVERSITY OF VIRGINIA · Feb 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called colchicine in patients who have been hospitalized for worsening heart failure, specifically heart failure with reduced ejection fraction (HFREF). The trial aims to see if colchicine, which is known for its anti-inflammatory properties, can help improve outcomes for these patients during their hospital stay and beyond. Participants in the trial will be randomly assigned to receive either colchicine or a placebo (a pill that looks the same but has no active medication) for a period of 90 days, while continuing their usual heart failure treatments.

To be eligible for this trial, participants must be adults aged 18 or older who have been diagnosed with acute decompensated heart failure and show signs of inflammation. This includes having specific symptoms or test results indicating heart dysfunction. Participants will have regular check-ups, including blood tests, to monitor their health and response to the treatment. It's important to know that certain medical conditions or medications may exclude someone from participating. Overall, the goal of this trial is to explore whether colchicine can provide benefits in managing heart failure, which could help improve care for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Primary admission diagnosis of acute decompensated heart failure as evidenced by:
• * Heart failure symptoms and at least one of the following:
• • Pulmonary congestion/edema at physical exam (or chest radiography)
• • E/e' \> 13 on transthoracic echocardiography
• • Left heart catheterization showing elevated left ventricular (LV) end-diastolic pressure \>18 mmHg or right heart catheterization showing pulmonary artery occluding pressure (wedge) \>16 mmHg
• • Elevated plasma B-type natriuretic peptide (\>100 pg/ml) or N-terminal B-type natriuretic peptide (\>300 pg/ml)
• • 2. LV systolic dysfunction (left ventricular ejection fraction \[LVEF\] \<40%) during the index hospitalization or prior 12 months;
• • 3. Expected duration of heart failure at least three months
• • 4. Age 18 years or older
• • 5. Willing and able to provide written informed consent
• • 6. Screening plasma CRP \>0.3 mg/dL (3 mg/L) or high-sensitivity CRP \>2 mg/L
• Exclusion Criteria:
• • 1. Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study, including but not limited to acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration
• • 2. Cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries performed within 3 months or planned during the admission
• • 3. Previous or planned implantation of left ventricular assist devices or heart transplantation
• • 4. Chronic use of intravenous inotropes
• • 5. Current or recent (i.e. within 4 half-lives) use of immunosuppressive or anti-inflammatory drugs (not including NSAIDs).
• • 6. Current treatment with colchicine or planned initiation of colchicine therapy in the next three months for gout
• • 7. Chronic inflammatory disorder, including but not limited to rheumatoid arthritis and systemic lupus erythematosus
• • 8. Active infection (of any type)
• • 9. Chronic or recurrent infectious disease, including hepatitis B virus, hepatitis C virus, and HIV/AIDS
• • 10. Prior (within the past 5 years) or current malignancy, with the exclusion of in situ lesion with low potential for progression
• • 11. Any comorbidity leading to expected survival less than three months or inability to complete the study
• • 12. End-stage kidney disease requiring renal replacement therapy
• • 13. Neutropenia (\<2,000/mm3) or Thrombocytopenia (\<50,000/mm3)
• • 14. Pregnancy
• • For all biological females with child bearing potential a pregnancy test will be performed as part of standard of care.
• • 15. Presence of specific contraindications to colchicine treatment, which may include
• • Previous adverse reaction to colchicine
• • Biliary obstruction
• • Renal impairment with estimated glomerular filtration rate (eGFR) \<30 ml/min
• • Liver cirrhosis from stage Child-Pugh A to more advanced
• • 16. Prisoners
• • 17. Treatment with medication contraindicated for concomitant use with colchicine per
• Food and Drugs Administration labeling, including:
• • Protease inhibitors
• • Macrolides antibiotic
• • Ketoconazole, Fluconazole and Itraconazole
• • Nefazodone
• • Non-dihydropiridine calcium channel blockers
• • Aprepitant
• • Ranolazine
• • Cyclosporine