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Colchicine for Acutely Decompensated Heart Failure

This study is looking at whether a drug called colchicine can help people who are in the hospital with acutely decompensated heart failure (a sudden worsening of heart failure symptoms). Heart failure with reduced ejection fraction (HFREF) means your heart isn't pumping blood as effectively as it should. Researchers want to see if colchicine can reduce inflammation, which is measured by a marker in your blood called hsCRP (high sensitivity C-reactive protein). You would either receive colchicine or a placebo (an inactive pill that looks like the drug) for about 3 months. The main goal is to see the difference in hsCRP levels between the colchicine and placebo groups within the first 72 hours of treatment. Anyone 18 or older with a primary diagnosis of acute decompensated heart failure can potentially join.

Study design
This is a double-blind, placebo-controlled pilot study, meaning neither you nor your doctors will know if you are receiving colchicine or the placebo. About 30 people are expected to participate.
What's involved
You would take either colchicine or a placebo pill twice a day for 14 days, then once a day for about 76 days. If you have kidney disease, your dose might be adjusted.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement for this study is taken within the first 72 hours of treatment.

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NCT06286423

Colchicine in Acutely Decompensated HFREF

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Virginia
~30 participants
Updated 2024-05-08 on ClinicalTrials.gov
What's tested:Colchicine 0.6 mgControl/Placebo group

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in the change in high sensitivity C-reactive protein (hsCRP) between colchicine arm and placebo arm in the first 72 hours of treatment
Measured over Baseline to 72 hours

Conditions

Heart Failure
Decompensated Heart Failure
Heart Failure With Reduced Ejection Fraction

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Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Antonio Abbate, MD · PRINCIPAL_INVESTIGATOR · UVA Health

Who to contact

Austin Hogwood
[email protected]
(804)536-7036
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
Protease inhibitors
Macrolides antibiotic
Ketoconazole, Fluconazole and Itraconazole
Nefazodone
Non-dihydropiridine calcium channel blockers
Aprepitant
Ranolazine
Cyclosporine

What this trial measures

  • Difference in the change in high sensitivity C-reactive protein (hsCRP) between colchicine arm and placebo arm in the first 72 hours of treatmentBaseline to 72 hours

    Change in plasma concentration of hsCRP between baseline and after 72 hours after treatment initiation, comparing colchicine arm vs placebo