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New treatment option for Heart Failure
Official title Colchicine in Acutely Decompensated HFREF
ClinicalTrials.gov ID: NCT06286423
What this study is testing
What is Colchicine 0.6 mg?
Colchicine 0.6 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for heart failure.
Also referred to as Colcrys, Gloperba.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study, including but not limited to...
- Cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries performed within 3 months or planned...
- Previous or planned implantation of left ventricular assist devices or heart transplantation
- Chronic use of intravenous inotropes
- Current or recent (i.e. within 4 half-lives) use of immunosuppressive or anti-inflammatory drugs (not including NSAIDs).
- Current treatment with colchicine or planned initiation of colchicine therapy in the next three months for gout
See the full eligibility criteria
- 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)
- LV systolic dysfunction (left ventricular ejection fraction [LVEF] \<40%) during the index hospitalization or prior 12 months;
- Expected duration of heart failure at least three months
- Age 18 years or older
- Willing and able to provide written informed consent
- Screening plasma CRP \>0.3 mg/dL (3 mg/L) or high-sensitivity CRP \>2 mg/L
- 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...
- Cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries performed within 3 months or planned during the admission
- Previous or planned implantation of left ventricular assist devices or heart transplantation
- Chronic use of intravenous inotropes
- Current or recent (i.e. within 4 half-lives) use of immunosuppressive or anti-inflammatory drugs (not including NSAIDs).
- Current treatment with colchicine or planned initiation of colchicine therapy in the next three months for gout
- Chronic inflammatory disorder, including but not limited to rheumatoid arthritis and systemic lupus erythematosus
- Active infection (of any type)
- Chronic or recurrent infectious disease, including hepatitis B virus, hepatitis C virus, and HIV/AIDS
- Prior (within the past 5 years) or current malignancy, with the exclusion of in situ lesion with low potential for progression
- Any comorbidity leading to expected survival less than three months or inability to complete the study
- End-stage kidney disease requiring renal replacement therapy
- Neutropenia (\<2,000/mm3) or Thrombocytopenia (\<50,000/mm3)
- Pregnancy
- For all biological females with child bearing potential a pregnancy test will be performed as part of standard of care.
- 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
- Prisoners
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.