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Anti-inflammatory

Colchicine for Heart Failure

Phase 4

Recruiting

Led By Antonio Abbate, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary admission diagnosis of acute decompensated heart failure as evidenced by heart failure symptoms and specific diagnostic criteria

Age 18 years or older

Must not have

End-stage kidney disease

Specific contraindications to colchicine treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 90 days

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial aims to test the effectiveness of a drug called colchicine in reducing inflammation in patients admitted to the hospital for heart failure. Patients will be randomly assigned to receive either colchicine or a

Who is the study for?

This trial is for hospitalized patients with acutely decompensated heart failure (ADHF) and signs of inflammation. Participants can have a dose reduction if they have Stage III chronic kidney disease or gastrointestinal symptoms, but must stop the medication temporarily if they experience acute kidney injury.

What is being tested?

The study tests Colchicine, an anti-inflammatory drug, against a placebo in addition to standard heart failure care. Patients are randomly assigned to either take Colchicine twice daily for two weeks then once daily for about 11 weeks, or a matching placebo schedule.

What are the potential side effects?

Colchicine may cause gastrointestinal symptoms which could lead to dose reduction; it will be stopped if there's acute kidney injury. Other side effects aren't specified but typically include diarrhea, nausea, and potential risk of muscle damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was admitted to the hospital for worsening heart failure symptoms.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidneys are in the final stage of failure.

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I cannot take colchicine due to specific health reasons.

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I am not taking any medications that cannot be used with colchicine.

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I have an ongoing infection or a long-term infectious disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Difference in change in plasma IL-6 concentration between colchicine arm and placebo arm in the first 72 hours of treatment

Difference in hsCRP area under curve between colchicine and placebo arm at 14 days

Other study objectives

Difference in the incidence of a composite of all-cause mortality or hospitalizations for heart failure at 90 days

Side effects data

From 2015 Phase 3 trial • 100 Patients • NCT01985425

Acute Respiratory Distress Syndrome

fall

100%

80%

60%

40%

20%

Study treatment Arm

Active Colchicine

Placebo Colchicine

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Colchicine 0.6 mg treatment groupExperimental Treatment1 Intervention

Treatment group will be given active drug (0.6mg Colchicine) 2x/day (once if subject has kidney disease) for 14 days. Subsequently treatment group subjects will be given active drug (0.6mg Colchicine) 1x/day for 76 +/- days (or once every other day if subject has kidney disease).

Group II: Control/Placebo groupPlacebo Group1 Intervention

Control/Placebo group will be given placebo that looks identical to study drug with no active ingredients and will take 2x/day (once if subject has kidney disease) for 14 days. Subsequently Control/Placebo group will be given placebo 1x/day for 76 +/- days (or once every other day if subject has kidney disease).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Colchicine 0.6 mg

2021

Completed Phase 3

~980

0 / 6Eligibility criteria met