Colchicine for Heart Failure

Overseen By Francesco Moroni, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Virginia

Must not be taking: Immunosuppressives, Anti-inflammatories, Colchicine, others

Disqualifiers: Acute coronary syndromes, Uncontrolled hypertension, Chronic pulmonary disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 72

Duration: 90±14 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether colchicine, an anti-inflammatory drug, can aid people with heart failure experiencing a sudden worsening of symptoms. Participants will receive either colchicine or a placebo, alongside their usual heart failure treatments, to determine if the drug reduces inflammation and improves outcomes. Suitable candidates include those admitted to the hospital with acute heart failure symptoms and inflammation, who have been managing heart failure for at least three months. As a Phase 4 trial, colchicine is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not require you to stop your current heart failure medications, as colchicine will be added to your existing treatment. However, if you are taking certain medications that are contraindicated with colchicine, such as protease inhibitors or specific antibiotics, you may need to stop those.

What is the safety track record for colchicine?

Research has shown that colchicine is generally safe for people. A large study, LoDoCo2, found that most individuals could take low-dose colchicine without serious side effects, though some experienced mild issues like an upset stomach.

The FDA has approved colchicine to help lower the risk of heart attacks and strokes, indicating its safety for long-term use.

This trial tests colchicine for heart failure, but existing safety data for other heart conditions is reassuring. Always consult a doctor to understand the risks and benefits before joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Colchicine is unique because it offers a novel approach to treating heart failure by targeting inflammation, which is a different strategy compared to standard treatments like ACE inhibitors, beta-blockers, and diuretics that primarily focus on managing blood pressure and fluid balance. Researchers are excited about colchicine because it has the potential to address underlying inflammation, which may improve heart function and outcomes for patients. Additionally, colchicine is a well-known anti-inflammatory agent with an established safety profile, which could make it a valuable addition to existing heart failure therapies.

What evidence suggests that colchicine might be an effective treatment for heart failure?

Research has shown that colchicine, a drug primarily used for gout, might also benefit heart problems. Studies on individuals with coronary artery disease found that colchicine reduced inflammation markers like CRP (C-reactive protein) and decreased heart issues. This is significant because inflammation can lead to heart failure. In this trial, participants in the colchicine treatment group will receive the drug to evaluate its potential benefits for heart failure. Although colchicine is not yet a standard treatment for heart failure, its ability to reduce inflammation makes it a promising option. Additionally, its safe use in other heart conditions suggests it could also benefit those with heart failure. ^{1 2 3 5 6}

Who Is on the Research Team?

Antonio Abbate, MD

Principal Investigator

UVA Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Expected duration of heart failure at least three months

Willing and able to provide written informed consent

Screening plasma CRP >0.3 mg/dL (3 mg/L) or high-sensitivity CRP >2 mg/L

Exclusion Criteria

Pregnancy

Previous or planned implantation of specific devices or transplantation

Abnormal blood counts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Colchicine or placebo. Colchicine is administered at 0.6 mg twice daily for 14 days, followed by 0.6 mg once daily for 76±14 days.

90±14 days

Inpatient visits for initial 72 hours, outpatient visit at 14±7 days, and study closure visit at 90±14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of hsCRP and IL-6 levels.

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Colchicine

Trial Overview

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.

How Is the Trial Designed?

Group I: Colchicine 0.6 mg treatment group Experimental Treatment 1 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 group Placebo Group 1 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).

Colchicine is already approved in United States for the following indications:

Approved in United States as Colcrys for:

• Gout
• Familial Mediterranean Fever

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

Colchicine has emerged as a promising treatment in cardiovascular disease due to its unique anti-inflammatory mechanism, making it safer than most current anti-inflammatory drugs for patients with heart conditions.

While colchicine is well-established for acute inflammatory conditions like pericarditis, its potential benefits in chronic conditions such as coronary artery disease and heart failure are still being explored, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colchicine in Coronary Artery Disease: An Old Acquaintance in New Attire? Giannopoulos, G., Angelidis, C., Papoutsidakis, N., et al.[2019]

In a multicenter trial involving 240 patients with multiple recurrences of pericarditis, colchicine significantly reduced the rate of recurrent pericarditis compared to placebo, with only 21.6% of patients in the colchicine group experiencing recurrences versus 42.5% in the placebo group (p=0.0009).

Colchicine was found to have a similar safety profile to placebo, with no serious adverse events reported, suggesting it can be safely added to conventional anti-inflammatory treatments for managing recurrent pericarditis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis (CORP-2): a multicentre, double-blind, placebo-controlled, randomised trial. Imazio, M., Belli, R., Brucato, A., et al.[2022]

Colchicine has been shown to significantly reduce the risk of recurrence in acute and recurrent pericarditis by half, based on clinical trials involving over 1600 patients.

In larger studies with more than 11,000 patients, colchicine demonstrated a greater than 30% reduction in cardiovascular events, including death and heart attacks, while being generally safe for long-term use at doses of 0.5-1.0 mg daily.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colchicine and the heart. Imazio, M., Nidorf, M.[2021]

The Impact-Reco programme analyzed prescription rates of heart failure medications in nearly 4,000 stable outpatients, revealing significant increases in the use of angiotensin receptor blockers and beta-blockers, indicating improved treatment practices over time.

Despite these improvements, the study highlighted that certain patient subgroups, particularly the elderly and those with renal failure, still received suboptimal doses of medications, suggesting a need for further enhancements in treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in the management of chronic heart failure since the publication of the updated guidelines of the European Society of Cardiology. The Impact-Reco Programme. de Groote, P., Isnard, R., Clerson, P., et al.[2022]

ACE inhibitors are effective in reducing both morbidity and mortality in patients with chronic heart failure (CHF), and they may also help prevent the progression to overt CHF in those with asymptomatic left ventricular dysfunction.

The review provides guidelines for the use of ACE inhibitors in both hospital and general practice settings, while also addressing the role of digoxin and the management of related conditions like angina and arrhythmias in CHF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problems solved and lives saved? Chronic heart failure. McMurray, J., Francis, M.[2013]

In a study of 267 patients with stable chronic heart failure, colchicine treatment significantly reduced inflammation markers like C-reactive protein and interleukin-6, indicating its anti-inflammatory effects.

However, colchicine did not lead to significant improvements in functional status or exercise tolerance, nor did it reduce the risk of death or hospital stays compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-inflammatory treatment with colchicine in stable chronic heart failure: a prospective, randomized study. Deftereos, S., Giannopoulos, G., Panagopoulou, V., et al.[2015]

Colchicine is considered safe and effective for treating recurrent pericarditis, with specific precautions, although its efficacy for acute pericarditis is less established and requires more research.

The review highlights the importance of understanding potential side effects and drug interactions, suggesting that while colchicine can be beneficial, careful monitoring is necessary during its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colchicine for pericarditis: hype or hope? Imazio, M., Brucato, A., Trinchero, R., et al.[2013]

In a study of 120 patients with their first episode of acute pericarditis, adding colchicine to conventional treatment significantly reduced the recurrence rate from 32.3% to 10.7% over 18 months, indicating its efficacy as an adjunct therapy.

Colchicine was well-tolerated with no serious adverse effects reported, although 8.3% of patients discontinued due to diarrhea, suggesting it is a safe option for managing acute pericarditis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Imazio, M., Bobbio, M., Cecchi, E., et al.[2014]

In a study of 12 patients with chronic heart failure, nisoldipine significantly improved cardiac index and reduced mean arterial pressure and systemic vascular resistance after acute administration, indicating its potential to enhance heart function.

The hemodynamic effects of nisoldipine peaked one hour after administration and lasted for up to six hours, suggesting it may provide short-term relief in heart failure symptoms without significantly affecting right atrial and pulmonary pressures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and chronic effects of the dihydropyridine calcium antagonist nisoldipine on the resting and exercise hemodynamics, neurohumoral parameters, and functional capacity of patients with chronic heart failure. Dei Cas, L., Metra, M., Ferrari, R., et al.[2019]

Colchicine, an ancient drug, is gaining attention for its potential benefits in treating cardiovascular diseases, as highlighted by recent studies up to October 2016.

It is crucial for healthcare professionals to understand both the therapeutic advantages and the risks, including side effects and drug interactions, associated with colchicine in cardiac care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching an Old Dog New Tricks: Colchicine in Cardiovascular Medicine. Chen, K., Schenone, AL., Borges, N., et al.[2018]

In a study of 25 patients with mild to moderate heart failure, treatment with lacidipine significantly improved key measures of heart function, including peak oxygen consumption and cardiac index, over an 8-week period.

Lacidipine also reduced systemic vascular resistance, suggesting it may help improve blood flow in heart failure patients, making it a potential adjunct therapy alongside standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of lacidipine on peak oxygen consumption, neurohormones and invasive haemodynamics in patients with mild to moderate chronic heart failure. de Vries, RJ., Dunselman, PH., Chin Kon Sung, UG., et al.[2019]

The LoDoCo2 trial is investigating the efficacy and safety of low-dose colchicine (0.5 mg daily) in 5522 patients with stable coronary artery disease, aiming to confirm its potential for secondary prevention of cardiovascular events.

This study is designed to detect a 30% reduction in major cardiovascular events, such as heart attacks and strokes, while also monitoring for any adverse effects related to colchicine, indicating a thorough approach to evaluating its safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of low-dose colchicine in patients with stable coronary artery disease: The LoDoCo2 trial rationale, design, and baseline characteristics. Nidorf, SM., Fiolet, ATL., Eikelboom, JW., et al.[2023]

Low-dose colchicine significantly reduces the rate of major adverse cardiovascular events and acute coronary syndrome in patients with coronary artery disease, based on a review of 11,955 patients across multiple randomized controlled trials.

While colchicine is generally safe, it is associated with an increased risk of gastrointestinal events, highlighting the need for monitoring in patients receiving this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Dose Colchicine in Coronary Artery Disease - Systematic Review and Meta-Analysis. Abrantes, AM., Nogueira-Garcia, B., Alves, M., et al.[2021]

The CORP and CORP-2 trials are set to be the first randomized placebo-controlled studies investigating the efficacy of colchicine in treating recurrent pericarditis, enrolling a total of 360 patients across both trials.

These trials aim to clarify the effectiveness of colchicine in reducing recurrence rates and improving symptoms over 18 months, potentially establishing it as a standard treatment option for patients experiencing recurrent pericarditis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CORP (COlchicine for Recurrent Pericarditis) and CORP-2 trials--two randomized placebo-controlled trials evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of recurrent pericarditis: study design and rationale. Imazio, M., Cecchi, E., Ierna, S., et al.[2013]

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Efficacy and safety of colchicine in patients with coronary artery disease: An updated meta-analysis of randomized controlled trials. Am Heart J ...

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nejm.org/doi/full/10.1056/NEJMoa2021372

Colchicine in Patients with Chronic Coronary Disease

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jacc.org/doi/10.1016/j.jacc.2023.05.055

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In patients with coronary artery disease taking aspirin and statins, colchicine incrementally reduces CRP levels as well as low-attenuation ...

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Colchicine in patients with coronary artery disease. This updated meta-analysis (including CLEAR-SYNERGY) shows the large benefits of low-dose ...

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Colchicine for Cardiovascular Disease: Navigating the Gap ...

Low-dose colchicine was approved in 2023 for chronic use by the US Food and Drug Administration to “reduce the risk of myocardial infarction, stroke, coronary ...