Phase 2 Cardiomyopathy Trial, Recruiting NCT04500665 Sponsor: Brigham and Women's Hospital Condition: Cardiomyopathy
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Phase 2 Cardiomyopathy Trial, Recruiting

NCT04500665
Recruiting Phase 2

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:

  • You are between 21 and 80 years old (inclusive)
  • Your kidneys are working at a reduced but not completely failed level, based on a specific kidney function test result (eGFR between 15 and 75)
  • A urine test shows a certain level of protein leaking into your urine (albumin-to-creatinine ratio above 30 mg/g)
  • If your urine protein level is higher (above 300 mg/g), you are already taking the highest dose of a blood pressure/kidney-protecting medication you can tolerate (an ACE inhibitor or ARB)
  • If your doctor recommends it, you are already taking a type of diabetes/kidney medication called an SGLT-2 inhibitor
  • You are willing and able to sign a consent form and follow the study plan

Who may not be able to join:

  • You have had a bad reaction or allergy to colchicine in the past
  • You were in the hospital for any reason in the last 30 days
  • You have an urgent medical condition that needs immediate treatment right now
  • You have moderate or advanced heart failure (Stage C or D)
  • Your heart is pumping less than 40% of its normal capacity
  • You have heart valve disease that is causing symptoms
  • You were born with a heart defect, whether or not it has been repaired
  • You have previously had a heart transplant
  • Your kidneys have completely failed, meaning you have had a kidney transplant or you are on dialysis (hemodialysis or peritoneal dialysis)
  • Your kidney function has gotten significantly worse in the last 30 days or the last 7 days
  • You have taken anti-inflammatory or immune-suppressing medications in the last 30 days (with some limited exceptions for short-term use — confirm with trial site)
  • You have Familial Mediterranean Fever, a gout flare within the last 12 months, pericarditis, or another condition that would normally be treated with colchicine
  • You have taken antibiotics or other antimicrobial medicines in the last 30 days, or you currently have an active infection
  • You have a history of breathing or lung problems that a doctor believes could raise your risk of pneumonia
  • You had surgery in the last 30 days, or you have surgery planned during the study period
  • You currently have cancer, or you have been treated for cancer within the last year
  • A doctor believes that your overall health or life expectancy due to serious illness would make participation too risky
  • Your white blood cell (neutrophil) count is too low, based on a blood test
  • Your platelet count is too low, based on a blood test
  • You are taking certain medications that can interact dangerously with colchicine, such as cyclosporine, clarithromycin, diltiazem, verapamil, itraconazole, ritonavir, digoxin, or others — including regular grapefruit juice (confirm with trial site)
  • You are taking certain cholesterol or fat-lowering medications (such as simvastatin, gemfibrozil, or fenofibrate), or a blood test shows your muscle enzyme levels are too high
  • You have moderate or severe liver disease
  • You are pregnant, breastfeeding, or are unwilling or unable to use appropriate contraception during the study

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 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Leo F Buckley, PharmD MPH, Brigham and Women's Hospital

Phone: 617-732-5500

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 2
Registry
ClinicalTrials.gov
Start date
1 November 2021
Est. completion
31 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Between-group change in left ventricular global longitudinal strain

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