What is colchicine studying for heart failure with reduced ejection fraction?

Colchicine is being studied to see if it can reduce inflammation in patients hospitalized with acutely decompensated heart failure with reduced ejection fraction. This trial compares colchicine to a placebo to understand if it lowers inflammation markers during a vulnerable period after heart failure worsening. The study is sponsored by the University of Virginia.

Who may be eligible for this heart failure clinical trial?

Adults aged 18 years or older with acute decompensated heart failure and reduced ejection fraction below 40% may be eligible. Participants need to have elevated inflammation markers and be able to provide consent. People with recent heart surgeries, severe kidney disease, or current colchicine use may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this heart failure clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID06286423

Pilot Study of Colchicine Treatment in Adults Hospitalized with Acutely Decompensated Heart Failure With Reduced Ejection Fraction

Led by University of Virginia · Updated on 2024-05-08

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

This research evaluates colchicine, an anti-inflammatory drug, in patients hospitalized with acutely decompensated heart failure with reduced ejection fraction HFrEF who also show signs of inflammation. The study aims to compare colchicine with placebo to see if it reduces inflammation markers, such as high sensitivity C-reactive protein hsCRP and interleukin-6 IL-6, during the vulnerable period following heart failure exacerbation. This pilot trial is randomized, double-blind, and placebo-controlled, designed to explore colchicines role alongside standard heart failure care, which includes medications to relieve symptoms and support heart function. Participants will be randomly assigned to receive either colchicine or a matching placebo. The colchicine group will take 0.6 mg twice daily for 14 days, followed by 0.6 mg once daily for about 76 days dose adjustments are made for patients with chronic kidney disease or gastrointestinal symptoms. The placebo group follows the same schedule with inactive pills. Treatment will add to usual heart failure care without withholding any standard medications. The study includes a 90-day treatment period to cover the vulnerable phase when patients are at higher risk of further heart failure events. During the study, blood samples will be collected at baseline, 24, 48, and 72 hours after treatment start while still hospitalized, plus at 14 days during an outpatient visit and at the study conclusion around 90 days. Researchers will monitor inflammation markers and assess clinical status, medication compliance, and safety throughout. The primary outcome is the change in hsCRP within the first 72 hours, with secondary outcomes including longer-term hsCRP and IL-6 changes. Participants will be followed closely to understand colchicines impact on inflammation in this high-risk period.

CONDITIONS

Brief Title

Colchicine in Acutely Decompensated HFREF

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Colchicine (investigational)	Placebo (trial comparator)	Guideline‑recommended standard care
What this option is	Colchicine added to usual care during hospitalization for acute decompensated HFrEF following a defined dosing schedule	Matching placebo given on the same dosing schedule as colchicine during hospitalization	Hospitalized patients with acute decompensated HFrEF receive guideline‑directed medical therapy including diuretics, neurohormonal blockers and other foundational agents
Role in trial	Investigational therapy tested for reduced inflammation in acute decompensation	Control arm to assess colchicine effects beyond standard care	Represents current standard therapy not tested in this trial
Primary use	To reduce inflammatory markers (e.g., hsCRP, IL‑6) in acute decompensated HFrEF	To serve as inert control matching colchicine regimen for inflammatory marker measurement	To stabilize volume status and initiate guideline‑directed medical therapy for HFrEF decompensation
How it is given or performed	Colchicine 0.6 mg twice daily for 14 days (once daily if kidney disease), then 0.6 mg daily or every other day for 76±1 days	Matching placebo on identical schedule as colchicine	IV diuretics during hospitalization followed by initiation or up‑titration of GDMT (ARNi, beta‑blocker, MRA, SGLT2 inhibitor) once decongested
Evidence status	Effectiveness of colchicine to reduce hsCRP or IL‑6 in acute decompensated HFrEF is under investigation in this trial (no results yet)	Placebo has no therapeutic efficacy—it serves to isolate colchicine effect	Guideline‑directed therapies reduce hospitalizations and mortality in HFrEF based on extensive trial evidence
Important risks	Potential colchicine risks such as gastrointestinal upset, cytopenias, renal or hepatic adverse effects are possible but not yet reported in-study	No pharmacologic risk beyond inert placebo	Standard HFrEF medications carry known risks (e.g., hypotension, renal dysfunction) that clinicians monitor carefully
Important limitations	Trial focuses on inflammatory markers, not clinical outcomes such as readmission or survival	Placebo arm does not provide information on clinical event benefit beyond inflammatory marker comparison	Guideline‑recommended care is based on strong data but colchicine benefit remains untested in this setting
Patient‑relevant impact	Not yet established—patient‑relevant outcomes are not measured in this trial	Not applicable—inert comparator without expected patient outcome impact	GDMT has demonstrated benefit in reducing hospitalization and improving survival in HFrEF

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Primary admission diagnosis of acute decompensated heart failure with symptoms and evidence such as pulmonary congestion, abnormal echocardiography, elevated heart pressures, or high natriuretic peptides
Left ventricular ejection fraction less than 40% during hospitalization or within prior 12 months
Heart failure duration expected to be at least three months
Age 18 years or older
Able and willing to provide written informed consent
Screening plasma CRP greater than 0.3 mg/dL (3 mg/L) or high-sensitivity CRP above 2 mg/L

You will not qualify if you...

Significant other health conditions interfering with study, including acute coronary syndromes, uncontrolled blood pressure, arrhythmias, lung diseases, or neuromuscular respiratory disorders
Recent or planned heart procedures such as CRT, revascularization, or valve surgery within 3 months
Previous or planned heart device implantation or transplantation
Chronic intravenous inotrope use
Recent or current use of immunosuppressive or anti-inflammatory drugs (excluding NSAIDs)
Current or planned colchicine treatment for gout
Chronic inflammatory or infectious diseases including rheumatoid arthritis, lupus, hepatitis B or C, HIV/AIDS
Recent or current cancer except low-risk in situ lesions
Life expectancy under three months or inability to complete the study
End-stage kidney disease needing dialysis
Low white blood cell or platelet counts
Pregnancy
Contraindications to colchicine such as prior adverse reactions, bile duct obstruction, severe kidney impairment, or liver cirrhosis
Prisoner status
Use of medications that interact with colchicine as per FDA guidelines, including certain antibiotics, antifungals, calcium channel blockers, and others

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 90 days

Participants receive either colchicine or placebo to reduce inflammation related to heart failure. The dosing includes twice daily for 14 days, then once daily (or every other day if kidney disease is present) for approximately 76 days.

Visits occur during the 90-day treatment period, timing according to dosing schedule