Study on Colchicine for Treating Patients with Inflammatory Cardiomyopathy

3 1 1

What is this study about?

This clinical trial is focused on studying the effects of the medication colchicine in treating patients with a heart condition known as inflammatory cardiomyopathy. This condition involves inflammation of the heart muscle, which can lead to heart problems such as irregular heartbeats and heart failure. The trial aims to determine how effective colchicine is in improving the health of patients with this condition over a period of six months.

Participants in the study will be randomly assigned to receive either colchicine or a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The study is designed to be single-blinded, meaning that the participants will not know whether they are receiving colchicine or the placebo. The treatment will be taken orally in the form of a tablet. Throughout the study, participants will be monitored for any changes in their heart condition, including improvements or worsening of symptoms.

The main goal of the study is to see if colchicine can help reduce inflammation and improve heart function in patients with inflammatory cardiomyopathy. The researchers will look at various health indicators, such as heart imaging results and the frequency of irregular heartbeats, to assess the effectiveness of the treatment. The study will also track any side effects or adverse reactions to the medication. By the end of the study, the researchers hope to gather valuable information about the potential benefits of colchicine for patients with this heart condition.

1 joining the trial

Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive the medication colchicine, and the other group will receive a placebo, which is a substance with no active medication. This process is called randomization and helps ensure the trial’s results are reliable.

2 medication administration

If you are in the group receiving colchicine, you will take a tablet orally. The dosage is 1 mg per day. This treatment will continue for a duration of 6 months.

3 regular check-ups

Throughout the trial, you will have regular check-ups to monitor your health and the effects of the treatment. These check-ups may include physical examinations, blood tests, and heart imaging tests such as echocardiograms or cardiac magnetic resonance imaging (CMRI).

4 monitoring symptoms

You will be asked to report any symptoms or changes in your health. This information is crucial for assessing the treatment’s effectiveness and any potential side effects.

5 end of treatment evaluation

At the end of the 6-month treatment period, a final evaluation will be conducted. This will include a comprehensive assessment of your heart health and any changes in your condition. The results will help determine the effectiveness of colchicine in treating inflammatory cardiomyopathy.

Who Can Join the Study?

Patients must be 18 years or older.
There must be evidence of myocardial inflammation (heart muscle inflammation) shown by specific tests like CMRI (a type of heart scan) or FDG-PET (a type of imaging test) done within the last 3 months before joining the trial, or within the last 12 months for the registry.
Patients must have one or more of the following conditions lasting for more than 1 month:
- A high number of premature ventricular contractions (PVCs) (extra heartbeats) of 3000 or more in 24 hours, or non-sustained ventricular tachycardias (NSVTs) (a fast heart rhythm lasting less than 30 seconds).
- Reduced left ventricular ejection fraction (LVEF) (a measure of how well the heart pumps blood) below 50% on an echocardiogram or below 60% on CMRI.
- Increased levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) of 1000 pg/mL or more, or B-type natriuretic peptide (BNP) of 200 pg/mL or more. These are substances in the blood that can indicate heart stress.
- Continued high levels of high-sensitivity troponin (a protein released when the heart muscle is damaged) above the normal limit after at least 2 months from the first test, along with a high number of PVCs of 1000 or more in 24 hours.

Who Cannot Join the Study?

Patients who are not diagnosed with inflammatory cardiomyopathy cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Centro Cardiologico Monzino S.p.A.	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Ospedale Santo Spirito In Sassia	Rome	Italy
Pbnkimvpejs Sxeajalgkszdvwoed	Bologna	Italy
Are Oiguxnqi Rzgwxrf Uqseldr Ikvsblhwvqxqnazid dm Ahxtax	Ancona	Italy
Orqufaan Sfagj Mtbjt dyora Mksvfjcgzzsv	Udine	Italy
Ojuljhwl Smf Dinotl	Arezzo	Italy
Aqwkrhz Okonfsugabt Uugwpqavkmjrq Cdqrsqlyttab Dltgi Snkjsa E Dnpbk Srbacea Dr Txxkfw	Turin	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	16.10.2023

Trial locations

Investigated drugs:

Colchicine

Colchicine is a medication that is being tested in this clinical trial to see if it can help treat patients with a heart condition called cardiomyopathy, which is linked to inflammation of the heart muscle, known as myocarditis. The trial aims to find out if colchicine can improve heart health in these patients when used alongside their usual medical treatments. Colchicine is thought to work by reducing inflammation, which might help the heart function better and prevent further damage.

Investigated diseases:

Cardiomyopathy

Inflammatory cardiomyopathy – Inflammatory cardiomyopathy is a condition characterized by inflammation of the heart muscle, which can lead to changes in the heart’s structure and function. The inflammation can cause the heart muscle to weaken, affecting its ability to pump blood effectively. Over time, this can result in symptoms such as fatigue, shortness of breath, and swelling in the legs and feet. The disease may progress with episodes of irregular heartbeats, known as arrhythmias, which can further impact heart function. As the condition advances, the heart may become enlarged, and its pumping ability may continue to decline. The progression of inflammatory cardiomyopathy can vary, with some individuals experiencing more rapid changes in heart function than others.

Trial ID:

2024-517945-14-00

Protocol code:

CMP-MYTHiC

NCT ID:

NCT06158698

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Colchicine for Treating Patients with Inflammatory Cardiomyopathy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?