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

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What is this study about?

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.

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.

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.

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.

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%.

5 safety assessment

The safety of dobutamine infusion is evaluated by monitoring for any complications or side effects during the study.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Site Name City Country Status
Region Midtjylland Aarhus Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.12.2023

Trial locations

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.

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.

Trial ID:
2023-508298-10-00
Trial Phase:
Therapeutic exploratory (Phase II)

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