Recruiting

Study on the Effects of Dobutamine on Heart Function in Patients with Wild-type Transthyretin Amyloid Cardiomyopathy

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Dobutamine in patients with a heart condition known as Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt). This condition affects the heart's ability to pump blood effectively. The study aims to understand how different doses of Dobutamine can impact heart function and to ensure the safety of this treatment in patients with ATTRwt.

During the trial, participants will receive Dobutamine through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The study will also use other solutions like Glukose Isotonisk and Sodium Chloride to support the treatment process. The trial will monitor changes in heart function using methods like right heart catheterization and echocardiography, which are techniques to assess how well the heart is working.

The study will take place over a period, with the goal of observing any improvements in heart function, such as increased cardiac output and stroke volume, as well as any potential side effects. The results will help determine the effectiveness and safety of Dobutamine for patients with ATTRwt, providing valuable insights into managing this heart condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participation is confirmed through informed consent. This involves understanding the study's purpose and agreeing to take part.
Step 2
Initial assessment
An initial assessment is conducted to confirm eligibility. This includes a diagnosis of wild-type transthyretin amyloid cardiomyopathy (ATTRwt) through genetic testing, specific imaging, or biopsy.
Additional criteria include being treated with loop diuretics, having a certain heart function level, and being at least 65 years old.
Step 3
Treatment phase
The treatment involves the administration of dobutamine through an intravenous infusion. This is a solution for injection or infusion designed to assess its effects on heart function.
The dosage of dobutamine is gradually increased to observe changes in cardiac output and filling pressures. This is monitored using right heart catheterization and echocardiography.
Step 4
Monitoring and evaluation
Throughout the treatment, heart function is closely monitored. The primary goal is to achieve a 10% increase in cardiac output or a 20% increase in stroke volume index.
Secondary goals include reducing certain pressures in the heart and improving heart function measurements by 10%.
Step 5
Safety assessment
The safety of dobutamine infusion is evaluated by monitoring for any complications or side effects during the study.
Step 6
Completion of study
The study is expected to conclude by December 1, 2025. Results will be analyzed to determine the effectiveness and safety of the treatment.

Who can join the trial?

6 criteria

The patient must have a confirmed diagnosis of **Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt)**. This can be confirmed through genetic testing, a special scan called **99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid (DPD) scintigraphy**, or a small tissue sample from the heart known as an **endomyocardial biopsy**.
The patient should be receiving treatment with **loop diuretics**, which are medications that help remove excess fluid from the body.
The patient must be classified as **New York Heart Association (NYHA) class II-IV**, which means they have some level of heart failure symptoms.
The patient must be **65 years of age or older**.
The patient should have a **left ventricular ejection fraction (LVEF)** of less than 50%. This is a measure of how well the heart pumps blood. Alternatively, the **stroke volume index (SVI)**, which is another measure of heart function, should be less than 35 ml/m² as assessed by an ultrasound of the heart called **echocardiography**.
The patient must provide **informed consent**, meaning they agree to participate in the study after understanding all the details and risks involved.

Who cannot join the trial?

4 criteria

Patients who do not have **Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt)** cannot participate. This is a specific heart condition.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are not detailed here but are important for safety and accuracy.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Region Midtjylland
Aarhus, Denmark

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Dobutamine is a medication used in this clinical trial to study its effects on the heart in patients with a specific type of heart condition called wild-type transthyretin amyloid cardiomyopathy (ATTRwt). The trial aims to see how dobutamine affects the heart's ability to pump blood and the pressures inside the heart. This is done by giving the medication through an infusion and measuring the heart's response using special tests. The study also looks at how safe dobutamine is for patients with this heart condition.

What is already known about the treatment

Dobutamine – Dobutamine is administered intravenously, typically through an infusion, allowing for precise control over dosage. It is currently being studied for its effects on heart function in patients with Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt). The main therapeutic use of dobutamine is to improve heart function by increasing cardiac output, which can be beneficial in heart failure conditions. At the molecular level, dobutamine works by stimulating beta-1 adrenergic receptors in the heart, leading to increased heart muscle contraction and improved blood flow. It is classified as a sympathomimetic drug, specifically a beta-adrenergic agonist.

Investigated diseases

Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt) – This is a heart condition where abnormal protein deposits, known as amyloids, accumulate in the heart tissue. These deposits can cause the heart to become stiff, leading to difficulties in pumping blood effectively. Over time, this can result in symptoms such as fatigue, shortness of breath, and swelling in the legs. The disease progresses as the amyloid deposits increase, further impairing heart function. It is a form of amyloidosis that specifically affects the heart, and it is not caused by genetic mutations. The condition is more common in older adults and can lead to significant cardiac issues if not managed properly.