Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Randomized double-blind trial to study the benefit of Colchicine in Patients with Acutely Decompensated Heart Failure

This study is for people who have recently had their heart failure symptoms suddenly get worse, a condition called 'acutely decompensated heart failure'. The main goal is to find out if a common medicine called Colchicine, at a low dose (0.5 mg), can help. Scientists will measure a specific substance in the blood, called NT-proBNP, which tells them about heart strain. They hope to see if Colchicine can lower these levels, suggesting an improvement in heart function. The study also aims to see if patients taking Colchicine feel more stable, spend fewer days in the hospital, and if it might even reduce the risk of serious problems. Participants will either receive the study medicine or a placebo (a dummy pill), and neither they nor their doctors will know which one they are getting.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia, Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Enrolment target

302

Start

03 Mar 2023

Acute decompensated heart failure

What is this study about?

When someone has heart failure, it means their heart isn't pumping blood as well as it should. Sometimes, symptoms like breathlessness or swelling can suddenly get much worse; doctors call this 'acutely decompensated heart failure'. It's a serious situation that often requires a hospital stay. This study is exploring whether a well-known medicine called Colchicine could be helpful for people experiencing this.

Colchicine is already used for other conditions, but researchers want to see if a low dose of it could benefit the heart in this specific situation. They are particularly interested in a blood test marker called NT-proBNP. Higher levels of this marker often mean the heart is under more strain. The study's main aim is to find out if taking Colchicine can lower these NT-proBNP levels, which would suggest the heart is working better.

Beyond just the blood test, the study will also look at how patients feel overall. This includes whether their condition becomes more stable, how many days they might need to spend in the hospital, and importantly, if it could help reduce the overall risk of serious health issues. By doing this research, doctors hope to find new ways to improve care and recovery for people whose heart failure has suddenly worsened.

Key takeaways

This study is testing if a medicine called Colchicine can help people with suddenly worse heart failure.
It aims to see if Colchicine improves heart function and overall health.
You will either receive Colchicine or a dummy pill, without knowing which one.
The study involves regular check-ups and blood tests.
Participation is entirely voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. There is no upper age limit, meaning people of all adult ages can take part. Both men and women are welcome to participate in this research.

The most important requirement is that you have recently experienced a sudden worsening of your heart failure symptoms, which doctors refer to as 'acutely decompensated heart failure'. This study is specifically designed for people in this situation.

There will be other detailed criteria that your doctor will check to make sure the study is safe and suitable for you. These criteria help ensure that the study results are clear and that everyone taking part is at the right stage of their condition.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently experienced a sudden worsening of your heart failure symptoms?
Are you able to attend regular clinic visits and follow study instructions?
Are you comfortable potentially receiving a placebo (dummy pill)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the study medicine, Colchicine (a 0.5 mg tablet), or a matching dummy pill (placebo). Neither you nor your doctor will know which one you're receiving, which helps make the study results fair.

You will have several visits to the clinic where doctors and nurses will monitor your health carefully. They will take blood samples, especially to check your NT-proBNP levels, and perform other tests to see how you are responding. You'll also be asked questions about how you're feeling and your symptoms.

The study will involve regular follow-up visits and assessments over a set period. The total duration of your participation will be explained in full by the study team, including how long you will be taking the medication and how long the follow-up period will last.

Potential risks and benefits

Taking part in any study always carries potential benefits and risks. You might benefit from closer medical attention and monitoring than usual, and if Colchicine proves effective, you could experience an improvement in your heart condition. However, there's no guarantee that you will receive the active medication or that it will help. Potential risks could include side effects from the medication, such as tummy upsets, or the inconvenience of extra clinic visits. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Italy

Common questions

What is Colchicine?

Colchicine is a medicine that's been used for many years for conditions like gout. This study is investigating if a low dose of it can also help people with heart failure that has suddenly gotten worse.

What is 'acutely decompensated heart failure'?

This is a medical term for when your heart failure symptoms, such as being very breathless or having swollen ankles, suddenly become much worse and often require urgent medical attention or a hospital stay.

What is NT-proBNP?

NT-proBNP is a substance that your body makes, and higher levels in your blood can be a sign that your heart is working harder than it should. Doctors use it to help understand how well your heart is doing.

Will I know if I'm getting the real medicine or a dummy pill?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you are receiving the active medicine (Colchicine) or a placebo (dummy pill). This helps ensure the study results are fair and accurate.

What if I decide I don't want to continue with the study?

You are free to leave the study at any time, for any reason, without needing to explain why. Your decision will not affect your regular medical care or relationship with your healthcare team.