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โ† Trials
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Colchicine in Acutely Decompensated HFREF

RecruitingPhase 4Ages 18 Years - anyAllUniversity of Virginia
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In plain words

What the trial is, and whether it could suit you

This is a double blind, placebo-controlled pilot trial randomizing patients admitted to the hospital with acutely decompensated heart failure (ADHF) and inflammation to receive either colchicine or matching placebo. Upon enrollment, patients will be randomized 1:1 to receive either the experimental drug (Colchicine) or matching placebo. The regimen in the active arm will consist of 14 days of Colchicine 0.6 mg bid followed by 76ยฑ14 days of Colchicine 0.6 mg once per day. Placebo regimen will be analogous, with one pill bid for 14 days followed by one pill once per day for 76 days. Dose reduction for patients with Stage III chronic kidney disease is allowed as detailed in the protocol. At the same time, dose reduction can also be elected in case of GI symptoms. The study team will transiently stop the experimental medication in case of acute kidney injury (AKI), defined per Kidney Diseas

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Colchicine 0.6 mg
  • Control/Placebo group
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Where

1 site
UVA Health
Charlottesville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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