Not yet recruitingRare disease

Study on Heart Amyloidosis Using Sodium Fluoride (18F) and Iodine (123I) Iobenguane for Patients with Transthyretin Amyloid Cardiomyopathy

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What is this trial about?

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

This clinical trial is focused on studying a heart condition known as transthyretin amyloid cardiomyopathy, which affects the heart's ability to function properly. The study will use two different treatments: sodium fluoride (18F) and iodine (123I) iobenguane. These treatments are given as a solution for injection, meaning they are administered directly into the bloodstream through an injection.

The purpose of the study is to understand how these treatments can help in measuring certain changes in the heart. Participants will undergo imaging tests, such as PET/CT scans, to see how the heart is affected by the disease and the treatments. The study will also look at how the heart's function changes over time, especially in terms of how it handles calcium deposits and nerve signals.

Throughout the study, participants will have regular check-ups and imaging tests to monitor their heart health. The study will last for about a year, and during this time, researchers will collect data to better understand the effects of the treatments on heart function and overall health. This information could help improve future treatments for people with transthyretin amyloid cardiomyopathy.

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
The study begins with the completion of an informed consent form. This document ensures understanding of the study's purpose and procedures.
Eligibility is determined based on age and specific heart conditions, such as transthyretin amyloid cardiomyopathy, AL amyloidosis, or hypertrophic cardiomyopathy.
Step 2
Initial imaging and assessment
Initial imaging involves a PET/CT scan using sodium fluoride (18f) to measure heart microcalcification. This is done through an intravenous injection.
An additional imaging test using iodine (123i) iobenguane is performed to assess heart function. This also involves an intravenous injection.
Step 3
Medication administration
The study includes the administration of tafamidis, a medication used to treat transthyretin amyloid cardiomyopathy. The dosage and frequency are determined by the study protocol.
Step 4
Follow-up imaging and assessment
After one year, the same imaging tests are repeated to evaluate changes in heart microcalcification and function.
The study measures differences in imaging results from the start of the study to this point.
Step 5
Additional assessments
Additional tests include cardiac magnetic resonance imaging to assess heart function and structure.
Blood tests are conducted to measure cardiac biomarkers, which help in evaluating heart health.
Clinical assessments, such as a six-minute walk test and quality of life questionnaires, are also part of the study.
Step 6
Completion of the study
The study is estimated to conclude by October 15, 2024. At this point, all data collected will be analyzed to understand the effects of the treatment.

Who can join the trial?

5 criteria

The patient must complete an informed consent form. This means they agree to participate in the study after understanding what it involves.
The patient must be older than 40 years if they have **ATTR** or **AL cardiac amyloidosis**. These are specific heart conditions where abnormal proteins build up in the heart.
The patient must be older than 30 years if they have **HCM**. This stands for **Hypertrophic Cardiomyopathy**, a condition where the heart muscle becomes thickened.
The patient must have **ATTR cardiac amyloid** or **AL amyloidosis** as per expert recommendations. These are guidelines set by specialists to diagnose these conditions.
The patient must have **Hypertrophic Cardiomyopathy** according to guidelines from the **European Society of Cardiology**. These are rules set by a group of heart experts in Europe.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with transthyretin amyloid cardiomyopathy cannot participate. This is a specific heart condition.
Patients who are not within the specified age range cannot participate. The study includes certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

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Universitair Medisch Centrum Groningen
Groningen, The Netherlands

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Investigated drugs

Tafamidis is a medication used in the trial to treat transthyretin amyloidosis, a condition that affects the heart. It works by stabilizing a protein called transthyretin, which can help prevent the formation of amyloid deposits in the heart tissue. This medication is being studied to see how it affects the heart over time, particularly in terms of reducing amyloid buildup and improving heart function.

What is already known about the treatment

Tafamidis – Tafamidis is administered orally in capsule form. It is currently recognized in medical literature as a treatment for transthyretin amyloid cardiomyopathy, a condition where abnormal protein deposits affect the heart. The medication works by stabilizing the transthyretin protein, preventing it from breaking apart and forming amyloid deposits. Tafamidis is classified as a transthyretin stabilizer and is used to improve heart function and quality of life in affected patients.

Investigated diseases

Transthyretin Amyloid Cardiomyopathy – This is a condition where abnormal protein deposits, known as amyloids, accumulate in the heart tissue. These deposits can lead to the thickening and stiffening of the heart walls, affecting its ability to pump blood effectively. Over time, this can result in symptoms such as fatigue, shortness of breath, and swelling in the legs and feet. The disease progresses as more amyloid proteins build up, further impairing heart function. It is a rare condition that can significantly impact the quality of life. The progression of the disease can vary among individuals, with some experiencing a gradual worsening of symptoms.