Phase 4 Heart Disease Trial, Recruiting NCT06286423 Sponsor: University of Virginia Condition: Heart Disease
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Phase 4 Heart Disease Trial, Recruiting

NCT06286423
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who were admitted to hospital primarily because of a sudden worsening of heart failure, confirmed by symptoms plus at least one of: fluid buildup in the lungs seen on exam or chest X-ray, specific measurements on a heart ultrasound, pressure readings from a heart procedure, or elevated heart failure blood markers
  • People whose heart's pumping function is reduced (the heart pumps out less than 40% of its blood with each beat), either measured during this hospital stay or within the past 12 months
  • People whose heart failure has been present for at least three months and is expected to continue
  • People aged 18 years or older
  • People who are willing and able to sign a written consent form
  • People whose blood test during screening shows elevated inflammation markers (CRP or high-sensitivity CRP above specified levels)

Who may not be able to join:

  • People who have other significant health conditions that could affect the study results or how it is carried out, such as a recent heart attack, poorly controlled blood pressure, certain heart rhythm problems, serious lung disease, or nerve and muscle conditions that affect breathing
  • People who have had, or have planned during this hospital stay, a heart resynchronisation device implanted, a procedure to open blocked heart arteries, or heart valve surgery within the past three months
  • People who have previously had, or are planned to receive, a mechanical heart pump device or a heart transplant
  • People who regularly receive heart-strengthening medication through an intravenous drip on an ongoing basis
  • People who are currently taking, or have recently taken (within a period based on the specific drug's duration in the body), medicines that suppress the immune system or reduce inflammation (not including common anti-inflammatory pain relievers such as ibuprofen)
  • People who are currently taking colchicine, or for whom colchicine is planned to be started within the next three months for gout
  • People who have a long-term inflammatory condition such as rheumatoid arthritis or lupus
  • People who currently have an active infection of any kind
  • People with ongoing or recurring infectious diseases, including hepatitis B, hepatitis C, or HIV/AIDS
  • People who have had a cancer diagnosis within the past five years or currently have cancer (with the exception of certain very low-risk, non-spreading lesions — confirm with trial site)
  • People with any other condition that means they are not expected to survive at least three months or would be unable to complete the study
  • People with severe kidney disease who require dialysis or another form of kidney replacement therapy
  • People with abnormally low levels of certain blood cells (white blood cells or platelets, below specified thresholds)
  • People who are pregnant (a pregnancy test will be carried out for all biological females who could potentially become pregnant, as part of standard care)
  • People who have specific reasons they cannot take colchicine, including: a previous bad reaction to colchicine; a blockage in the bile ducts; significantly reduced kidney function (below a certain filtration rate); or moderate to severe liver scarring (cirrhosis)
  • People who are currently incarcerated
  • People who are taking certain medications that are not safe to use alongside colchicine, as listed by the US Food and Drug Administration — these include certain HIV medicines (protease inhibitors), certain antibiotics (macrolides), certain antifungal medicines (ketoconazole, fluconazole, itraconazole), a medicine called nefazodone, certain blood pressure or heart medicines (non-dihydropyridine calcium channel blockers), aprepitant, ranolazine, and cyclosporine

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Antonio Abbate, MD, UVA Health

Phone: (804)536-7036

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
1 June 2024
Est. completion
1 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov