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Anti-inflammatory

Colchicine 0.6 mg treatment group 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 90 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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

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

~780

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,245,043 Total Patients Enrolled

11 Trials studying Heart Failure

1,522 Patients Enrolled for Heart Failure

Antonio Abbate, MDPrincipal InvestigatorUVA Health

1 Previous Clinical Trials

10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this medical study?

"As per clinicaltrials.gov, this research is presently enrolling participants. The study was initially listed on 2/1/2024 and most recently revised on 2/22/2024."

Answered by AI

What is the collective count of participants who are joining this medical research study?

"Affirmative. The details on clinicaltrials.gov specify that this study is actively seeking individuals to participate. Initially shared on February 1st, 2024, and most recently revised on February 22nd of the same year, recruitment aims to enroll around 30 subjects from a single designated location."

Answered by AI

What are the potential risks associated with the administration of Colchicine at a dosage of 0.6 mg in patients?

"Based on our evaluation at Power, the safety rating for the Colchicine 0.6 mg treatment group is graded as a 3 due to its Phase 4 status, indicating regulatory approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Colchicine in Acutely Decompensated HFREF

Antonio Abbate 2024. "Colchicine in Acutely Decompensated HFREF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06286423.