Study on Colchicine and Thiamine for Patients with Heart Failure from Ischemic Heart Disease

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What is this study about?

This clinical trial is focused on studying the effects of two treatments, colchicine and thiamine, on patients with heart failure caused by ischemic heart disease. Heart failure is a condition where the heart is unable to pump blood effectively, and ischemic heart disease is a type of heart disease caused by narrowed heart arteries, which can lead to heart attacks. The study aims to understand how these treatments might help improve outcomes for people with this type of heart failure.

Participants in the study will receive either colchicine, thiamine, or a placebo. Colchicine is a medication commonly used to treat gout, while thiamine, also known as vitamin B1, is a vitamin that helps the body convert food into energy. The study will compare the effects of colchicine and thiamine on heart-related events, such as heart attacks or hospital visits due to heart failure, and overall heart health. The study will last for a period of time, during which participants will be monitored for any changes in their condition.

The purpose of this study is to determine if colchicine or thiamine can reduce the risk of serious heart-related events in people with heart failure due to ischemic heart disease. By participating in this study, researchers hope to gather valuable information that could lead to better treatment options for individuals with this condition in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, heart disease history, and heart function.

Participants must be 45 years or older with documented ischemic heart disease causing heart failure.

2 initial assessment

An initial assessment is conducted to document heart failure symptoms and heart function.

This includes evaluating symptoms according to the New York Heart Association (NYHA) classification and measuring the heart’s ejection fraction.

3 medication administration

Participants are randomly assigned to receive either colchicine, thiamine, or a placebo.

Colchicine is administered as a 0.5 mg tablet for oral use.

Thiamine is administered as a 300 mg gastro-resistant tablet for oral use.

The placebo is a tablet designed to match the colchicine tablet.

4 treatment period

The treatment period involves regular administration of the assigned medication.

Participants are monitored for any heart-related events, such as heart failure hospitalizations or cardiovascular incidents.

5 monitoring and follow-up

Regular follow-up visits are scheduled to monitor health status and any side effects.

The study aims to observe the impact of the medications on heart failure outcomes and cardiovascular events.

6 completion of the study

The study is expected to conclude by April 2028.

Final assessments are conducted to evaluate the overall impact of the treatment on heart health.

Who Can Join the Study?

Must be 45 years old or older.
Must have ischemic heart disease as the cause of heart failure. This means having a history of coronary artery disease (CAD) and a determination that the heart failure is due to ischemic heart disease.
Must have NYHA class II-IV symptoms. This refers to the New York Heart Association classification, which describes the severity of heart failure symptoms. Class II-IV means experiencing symptoms with mild to severe physical activity.
Must have a left ventricular ejection fraction (LVEF) of 45% or less within one year before joining the study. LVEF is a measurement of how well the heart is pumping blood.
Must be receiving the best possible medical treatment for heart failure according to local clinical practice.
Can join the study whether they are in an outpatient setting (not hospitalized) or currently in the hospital.

Who Cannot Join the Study?

Patients who do not have Heart Failure cannot participate. Heart Failure is a condition where the heart doesn’t pump blood as well as it should.
Patients who do not have ischemic heart disease cannot participate. Ischemic heart disease is a condition where the heart’s blood supply is reduced, usually due to blockages in the heart’s arteries.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, so gender is not an exclusion criterion.
Patients who are part of a vulnerable population are not excluded, meaning they can participate if they meet other criteria.

Where you can join this trial?

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Other Sites

Site Name	City	Country
ARNAS Civico Di Cristina Benfratelli	Palermo	Italy
Azienda Sanitaria Locale Bari	Bari	Italy
Atdz Givyvs Ojemdemo Mmihafghcikza Nvliskea	Milan	Italy
Ulagpxqbhgirqvyty Pbyamixetcq Dzmmn Mmmskz	Ancona	Italy
Akzqcel Obcvyqpcdrq Ufcozvauvhtqk Ommkjalp Rnoejam	Foggia	Italy
Anvmqks Ongvcmaxxfj Pjjz Goinfrka Xkzob	Bergamo	Italy
Atmvikf Oeixmcevmxm S Gyncvwak Accebsifzd	Rome	Italy
Auephue Oglcyhckqthirimnmwakvholz Pzprloyyxnl Ge Ryzzccgbkboc Mcpdq Dy Cthpuci	Catania	Italy
Afrpgab Sxtknlfto Lyitmt Rgsr 1	Rome	Italy
Amwwqqu Skfgngesb Lvakgc Rxux 2	Rome	Italy
Ilpec Pbfylvwsxxv Sru Dacdxe	San Donato Milanese	Italy
Anqprlb Oqceqhchjyu Pxc Lfsvzcrxkjjqaszqe Cbqscvdgan	Catania	Italy
Akbaxrvdlp Mesltfb Hidewnqe	Lecco	Italy
Awfkuav Umprh Squqdplgs Ltgiem Ulufed 1	Perugia	Italy
Ayiguwf Udl Ivzkf Dz Rcdvmq Eylkjc	Reggio Emilia	Italy
Aztkmjr Uwjmj Szuewdstr Lmxajt Diluq Rofrjcf	Faenza	Italy
Sof Cquekkf Fswltydrt Htylhejt	Rome	Italy
Aciqweo Sikwx Szrgxwgzn Tceckqnccbmc Dlbba Vqdya Obsff	Saronno	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.09.2024

Trial locations

Investigated Drugs:

Colchicine is a medication used in this trial to see if it can help people with heart failure caused by ischemic heart disease. The study is looking at whether colchicine can reduce the risk of serious heart problems, such as heart-related death, heart failure events, or other heart-related issues like heart attacks or strokes.

Thiamine is being tested in this trial to find out if it can help people with heart failure due to ischemic heart disease. The focus is on whether thiamine can lower the chances of heart-related death or the need for hospitalization due to heart failure.

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body’s needs. It can result from various causes, including damage from a heart attack or high blood pressure. As the condition progresses, individuals may experience symptoms such as shortness of breath, fatigue, and swelling in the legs and ankles. Over time, the heart’s ability to function can worsen, leading to more severe symptoms and complications. The progression of heart failure can vary, with some people experiencing rapid changes, while others may have a more gradual decline. Management focuses on lifestyle changes and medications to help control symptoms and improve quality of life.

Trial ID:

2023-506675-96-00

Protocol code:

PHRI.COLT-HF

NCT ID:

NCT05873881

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Colchicine and Thiamine for Patients with Heart Failure from Ischemic Heart Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?