Study on Heart Failure Patients Using Hyperpolarized [1-13C]pyruvate to Explore Heart Metabolism

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What is this study about?

This clinical trial focuses on studying heart failure, a condition where the heart doesn’t pump blood as well as it should. The study uses a special form of pyruvic acid called Hyperpolarized [1-13C]pyruvate, which is given as an injection. This substance helps in visualizing the heart’s metabolism, which is how the heart uses energy.

The purpose of the study is to understand how the heart processes energy in patients with heart failure. This is done by using a technique called magnetic resonance imaging (MRI), which creates detailed images of the heart. The study aims to compare these images with other standard heart scans to see how well they match up.

Participants in the study will receive the injection of Hyperpolarized [1-13C]pyruvate and undergo MRI scans. The study will observe how the heart metabolizes the injected substance and will compare these findings with existing diagnostic methods. This research could provide new insights into heart function and potentially improve how heart failure is diagnosed and managed in the future.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as having chronic heart failure and being over 18 years of age.

A pregnancy test will be conducted if applicable, and you will be required to use safe and effective contraception throughout the study if you are not postmenopausal or surgically sterile.

2 consent and preparation

You will be asked to provide informed consent, indicating your willingness to participate in the study.

You will receive detailed information about the study procedures, including the use of hyperpolarized [1-13C]pyruvate for imaging your heart’s metabolism.

3 medication administration

You will receive an injection of hyperpolarized [1-13C]pyruvate through an intravenous (IV) line. This is a special form of pyruvic acid that helps visualize heart metabolism during imaging.

The administration will be done via IV injection or infusion, as determined by the study protocol.

4 imaging procedure

After the injection, you will undergo a magnetic resonance imaging (MRI) scan. This scan will help visualize and measure the metabolism of your heart.

The MRI will focus on how your heart processes the injected pyruvate, providing important information about your heart’s metabolic activity.

5 follow-up visits

You will have follow-up visits scheduled to monitor your health and gather additional data as needed.

These visits will help assess the effects of the study procedures and ensure your well-being throughout the trial.

Who Can Join the Study?

Must have chronic heart failure. This includes heart failure with both reduced and preserved ejection fraction (EF).
Must be over 18 years of age.
Must have a Left Ventricular Ejection Fraction (LVEF) between 10% and 60%. This is a measure of how well the heart is pumping blood.
Must have adequate blood and organ function, including:
- ANC (Absolute Neutrophil Count) of at least 1,500 per microliter (uL).
- Platelet count greater than 100 per microliter (uL).
- Serum creatinine up to 1.5 times the upper normal limit or a creatinine clearance of at least 30 milliliters per minute. Creatinine is a waste product in the blood that comes from muscle activity, and its level indicates kidney function.
Women who are not postmenopausal or surgically sterile must have a negative pregnancy test at the time of joining the study.
Must use safe and highly effective contraception throughout the study. This can include hormonal birth control or an intrauterine device (IUD). If the partner is not fertile or there are no sexual activities, this is also acceptable.
Having non-insulin dependent diabetes mellitus is allowed. This is a type of diabetes that does not require insulin treatment.
Must be Danish speaking.
Must be able and willing to follow the study requirements after giving informed consent.
For a specific part of the study (substudy 1A), must have ischemic heart disease and be referred for viability testing.

Who Cannot Join the Study?

Patients with heart failure cannot participate in the study. Heart failure is a condition where the heart does not pump blood as well as it should.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Auvsvx Uzixdipdmg Hmljzyqz	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	02.09.2019

Trial locations

Investigated drugs:

Pyruvic Acid

Hyperpolarized [1-13C]-pyruvate is a special form of pyruvate, which is a substance naturally found in the body. In this clinical trial, it is used to help doctors see how the heart is working in people with heart disease. By using a special type of imaging called magnetic resonance, doctors can watch how the heart uses pyruvate. This helps them understand more about the heart’s metabolism and how it might be different in people with heart problems. The goal is to compare this new way of looking at the heart with other standard methods to see if it provides better or more detailed information.

Heart failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body’s needs. It often begins with the heart muscle weakening or becoming too stiff, which affects its ability to fill with or pump blood. Over time, this can lead to fluid buildup in the lungs and other parts of the body, causing symptoms like shortness of breath and swelling in the legs. The condition can progress gradually, with symptoms worsening as the heart’s function declines. It can affect one or both sides of the heart, leading to different symptoms depending on the areas involved. The progression of heart failure can vary, with some individuals experiencing rapid changes while others have a more stable course.

Trial ID:

2024-515414-40-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Heart Failure Patients Using Hyperpolarized [1-13C]pyruvate to Explore Heart Metabolism

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