Using colchicine to treat acutely decompensated heart failure with reduced ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial investigates the effects of colchicine, an anti-inflammatory medication, on patients hospitalized with acutely decompensated heart failure and inflammation. Participants will be randomly assigned to receive either colchicine or a placebo for a total of 90 days, with a specific dosing regimen. The study aims to assess the safety and efficacy of colchicine in reducing inflammation and improving heart function in this patient population. The trial will monitor for adverse effects and adjust dosages as necessary based on kidney function and gastrointestinal symptoms.

Why it matters

Who can join: the full rules

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

Where it's running

• UVA Health
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Antonio Abbate, MD — UVA Health
• Study coordinator: Austin Hogwood
• Email: ach2jb@virginia.edu
• Phone: (804)536-7036

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.