Study on the Effects of Different Doses of Adenosine for Patients with Chronic Coronary Syndrome, with and without Heart Failure

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What is this study about?

This clinical trial is focused on studying a heart condition known as Chronic Coronary Syndrome (CCS). The trial will explore how the heart responds to a medication called Adenosine, which is used to increase blood flow to the heart. The study will compare the effects of a standard dose of Adenosine with a higher dose to see if there is a significant difference in how the heart reacts. Participants in the study will include healthy individuals, patients with suspected or known CCS without heart failure, and patients with suspected or known CCS with heart failure.

During the trial, participants will receive Adenosine through an intravenous infusion, which means the medication will be delivered directly into the bloodstream through a vein. Another medication, Gadoteric Acid, may be used as a contrast agent to help visualize the heart’s blood flow during imaging tests. The main goal of the study is to understand how different doses of Adenosine affect the heart’s blood flow, which will be measured using a special imaging technique called CMR (Cardiac Magnetic Resonance) imaging.

The trial aims to provide valuable insights into the treatment of Chronic Coronary Syndrome by determining the most effective dose of Adenosine for improving heart blood flow. This information could help doctors make better decisions about how to use Adenosine in patients with this heart condition. The study is expected to continue until 2026, with recruitment of participants starting in 2024.

1 joining the trial

Upon joining the trial, written consent is required to confirm participation. This ensures understanding and agreement to the trial’s procedures and objectives.

2 preparation for the trial

Refrain from consuming caffeine for at least 24 hours before the examination. This is important to ensure accurate results during the trial.

3 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying age, sex, and medical history related to chronic coronary syndrome or heart failure.

4 administration of medication

The trial involves the administration of adenosine through an intravenous infusion. Two different doses may be used: a standard dose of 140 micrograms per kilogram per minute or a high dose of 210 micrograms per kilogram per minute. The dose depends on the specific group assignment within the trial.

5 imaging procedure

A CMR imaging procedure will be performed to assess myocardial hyperemia, which is the increased blood flow to the heart muscle. This is measured in milliliters per minute per gram.

6 completion of trial participation

After the imaging procedure, participation in the trial is complete. Further instructions or follow-up may be provided based on the trial’s findings and requirements.

Who Can Join the Study?

The subject has given their written consent to participate in the trial.
Are referred for suspected or known Chronic Coronary Syndrome (CCS) or heart failure. Chronic Coronary Syndrome is a condition related to the heart’s blood supply.
Matches the inclusion criteria for sex and age, which means there are 6 females and 6 males from each group in each age decade from 40 to over 80 years old.
Matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c). Heart failure is when the heart doesn’t pump blood as well as it should.
No caffeine intake less than 24 hours prior to the examination. Caffeine is found in coffee, tea, and some soft drinks.

Who Cannot Join the Study?

Patients with a known allergy or adverse reaction to adenosine cannot participate. Adenosine is a medication used in this study.
Individuals with severe asthma or other serious lung diseases are excluded. Asthma is a condition that affects breathing.
Patients with very low blood pressure, known as hypotension, are not eligible. Hypotension means having blood pressure that is lower than normal.
People with certain heart rhythm problems, such as second or third-degree heart block, cannot join. Heart block is a condition where the heart beats irregularly.
Pregnant or breastfeeding women are not allowed to participate.
Individuals who have had a heart attack or stroke in the last three months are excluded.
Patients with severe liver or kidney disease cannot take part. The liver and kidneys are important organs that help filter and clean the blood.
Anyone currently participating in another clinical trial is not eligible.
Individuals with any other medical condition that the study doctors believe would make participation unsafe are excluded.

Where you can join this trial?

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Site Name	City	Country	Status
Region Skane Skanes Universitetssjukhus	Lund	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	02.04.2024

Trial locations

Investigated drugs:

Adenosine is a medication used in this trial to study its effects on blood flow in the heart. It works by widening the blood vessels, which can help increase blood flow to the heart muscle. This is important for understanding how the heart functions in different conditions, such as in healthy individuals or those with heart disease. The trial is looking at how the body responds to different amounts of adenosine to see if there are any differences in how well it works in these different groups of people.

Chronic Coronary Syndrome – Chronic Coronary Syndrome is a condition characterized by the narrowing or blockage of the coronary arteries over time, which reduces blood flow to the heart muscle. This condition often results from the buildup of fatty deposits, known as plaques, on the artery walls. As the disease progresses, individuals may experience chest pain or discomfort, especially during physical activity or stress, due to the reduced blood supply to the heart. Over time, the heart muscle may weaken, leading to decreased heart function. The condition can remain stable for long periods but may also lead to episodes of increased symptoms. It is important to monitor and manage lifestyle factors that can influence the progression of this disease.

Trial ID:

2023-505248-20-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Different Doses of Adenosine for Patients with Chronic Coronary Syndrome, with and without Heart Failure

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?