Active not recruitingNAINTERVENTIONAL

Amyloidosis TTR Flow Reserve Evaluation

This study is investigating a heart condition called amyloidosis, specifically when a protein called TTR builds up in the heart tissue. Some patients with this type of amyloidosis experience chest pain, similar to angina, even though their main heart arteries aren't blocked. Past research using a different type of scan (PET) suggested that very small blood vessels in the heart might not be working properly. This study will use a more widely available heart scan called SPECT to re-examine these findings. We also want to see if a medication called Tafamidis, used for this condition, might help improve how these tiny blood vessels work. The goal is to better understand chest pain in amyloidosis and potentially find ways to improve treatment.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre Hospitalier Régional d'Orléans

Enrolment target

Start

24 Feb 2022

Estimated completion

11 Dec 2026

Amyloid Cardiomyopathy

What is this study about?

Imagine your heart needing a constant supply of blood, just like a car needs fuel. In people with a condition called cardiac amyloidosis, a substance called amyloid builds up in the heart muscle. This can make the heart stiff and less able to pump blood effectively. Sometimes, people with this type of amyloidosis experience chest pain, similar to angina, which usually happens when the main heart arteries are narrowed or blocked. However, in these cases, the main arteries are often clear. This suggests that the problem might lie in the very small blood vessels within the heart muscle, which are too tiny to see with standard tests.

Previous studies using a special, but less common, heart scan called PET showed that blood flow to the heart muscle, and its ability to increase that flow when needed, was reduced in many people with cardiac amyloidosis. This study aims to confirm these findings using a different type of scan called SPECT. SPECT scans are more commonly available, which means if this scan proves useful, more people could benefit from this diagnostic approach. By using SPECT, we can get a detailed picture of how well blood is flowing to your heart muscle, both at rest and when it's working harder.

Additionally, this study wants to explore whether a medicine called Tafamidis, which is already used to treat TTR cardiac amyloidosis, can help improve the function of these tiny blood vessels in the heart. By doing this, researchers hope to gain a better understanding of what causes chest pain in these patients and to see if existing treatments could offer additional benefits beyond what is currently known.

Key takeaways

This study investigates TTR cardiac amyloidosis and chest pain.
It uses a special heart scan called SPECT to look at blood flow.
Researchers want to confirm previous findings and study Tafamidis.
The goal is to understand how tiny heart blood vessels work in this condition.
Participation will involve heart scans and other medical assessments.

Who may be eligible?

This study is looking for volunteers between 18 and 90 years old who speak French. You would need to have a specific type of heart amyloidosis confirmed by certain heart tests, like an ECG or MRI, and other scans. Importantly, you should be planning to start treatment with a medication called Tafamidis for your condition.

There are also some conditions that would mean you can't join the study. For example, if your heart failure is not due to this specific type of amyloidosis, or if you have a different type of amyloidosis. You also can't participate if you've previously had a liver or heart transplant, or if you have severe kidney or liver problems.

Other reasons you might not be able to join include if you're already taking certain medications (like some anti-inflammatory drugs or certain heart medicines), have previously taken Tafamidis or a similar drug, or if you've had a heart attack or certain severe blockages in your main heart arteries. Pregnant or breastfeeding women are also not able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 90 years old?
Do you speak and understand French?
Have you been diagnosed with TTR cardiac amyloidosis?
Are you planning to start treatment with Tafamidis?
Do you have severe kidney or liver problems, or have had a heart transplant?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will undergo a special heart scan called SPECT. This scan helps us look at the blood flow to your heart muscle. You will also have various other assessments, which may include physical exams, blood tests, and heart tracings (ECGs). The study will also evaluate the effects of Tafamidis, a medication for your condition, on your heart's microcirculation. The total duration of your participation will depend on the study's timeline and the follow-up assessments required, which will be explained in full detail by the study team.

Potential risks and benefits

Taking part in this study could help us better understand cardiac amyloidosis and how treatments like Tafamidis might improve heart health, potentially benefiting future patients. While the heart scan (SPECT) is generally safe, there are minor risks associated with any medical procedure, including exposure to a small amount of radiation, similar to other X-ray tests. You might also experience side effects from any study medications, though Tafamidis is an approved treatment. You are always free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (4)

CHU d'ANGERS
Verified postcode
Angers, France
CHU Caen
Verified postcode
Caen, France
CHU Orleans
Verified postcode
Orléans, France
CHRU de TOURS
Verified postcode
Tours, France

Common questions

What is SPECT?

SPECT is a special type of heart scan that helps doctors see how blood flows to your heart muscle, both when it's resting and when it's working harder.

What is cardiac amyloidosis?

Cardiac amyloidosis is a condition where an abnormal protein builds up in your heart, making it stiff and affecting how it works.

Why are you studying this condition?

We want to understand why some people with cardiac amyloidosis get chest pain, even if their main heart arteries aren't blocked, and if a medication called Tafamidis can help.

Will I take new medication in this study?

This study evaluates the effect of Tafamidis, a medication you would already be planning to take for your condition, on your heart's tiny blood vessels.

Is the SPECT scan safe?

The SPECT scan is generally safe. It involves a small amount of radiation, similar to other imaging tests, and potential minor risks, which the study team will explain.