RecruitingRare disease

Study on the Impact of Dapagliflozin on Quality of Life and Exercise Capacity in Patients with Transthyretin Cardiac Amyloidosis

Verified siteRegistered drugNo placebo

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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 the effects of a medication called dapagliflozin on patients with a heart condition known as amyloid transthyretin cardiac amyloidosis (ATTR-CA). ATTR-CA is a disease where abnormal protein deposits, called amyloids, build up in the heart, affecting its function. The medication being tested, dapagliflozin, is taken as a film-coated tablet and is commonly used to treat other conditions like diabetes. In this study, researchers aim to understand how dapagliflozin affects the quality of life and exercise capacity of people with ATTR-CA.

The purpose of the study is to determine the impact of dapagliflozin on the ability of patients with ATTR-CA to exercise. Participants in the study will be given either dapagliflozin or a placebo, and their progress will be monitored over a period of time. The study will look at changes in how far patients can walk in six minutes, which is a common way to measure exercise capacity. Additionally, researchers will assess improvements in patients' overall well-being and any changes in heart-related symptoms.

Throughout the study, the safety of dapagliflozin will be closely monitored by recording any side effects experienced by participants. The study will also evaluate if there are any changes in the use of other heart medications, such as diuretics, which help remove excess fluid from the body. By the end of the study, researchers hope to gather valuable information on how dapagliflozin can benefit patients with ATTR-CA, potentially leading to better treatment options in the future.

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, you will be asked to sign a written informed consent form. This confirms your understanding and agreement to participate in the study procedures.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, which should be between 18 and 90 years, and confirming a diagnosis of ATTR Cardiac Amyloidosis through specific medical tests.
Your medical history will be reviewed, focusing on any previous heart failure incidents or symptoms. It is important that any cardiovascular medications you are taking have been stable for at least two weeks before this assessment.
Step 3
Medication administration
You will be given Forxiga 10 mg film-coated tablets containing the active substance dapagliflozin. This medication is taken orally.
The dosage and frequency of the medication will be explained to you, and you will be required to take it as directed for the duration of the study.
Step 4
Regular monitoring
Throughout the study, your health and response to the medication will be regularly monitored. This includes measuring changes in your exercise capacity, such as the distance you can walk in six minutes.
Your quality of life will also be assessed using a questionnaire designed to evaluate heart-related symptoms and overall well-being.
Step 5
Safety evaluations
The safety of the medication will be evaluated by recording any adverse events or side effects you may experience.
Adjustments to your diuretic medication may be made if necessary, and any changes will be carefully monitored.
Step 6
Completion of the study
The study is expected to conclude by June 2025. Upon completion, a final assessment will be conducted to evaluate the overall effects of the medication on your health and exercise capacity.

Who can join the trial?

5 criteria

Ability to understand and sign a written informed consent. This means you need to be able to understand the study and agree to participate by signing a form before the study starts.
Age between 18 and 90 years.
An established diagnosis of ATTR Cardiac Amyloidosis (ATTR-CA). This is a specific heart condition confirmed by certain tests, such as a heart tissue biopsy or special imaging tests, and the absence of certain proteins in your blood or urine. If you have a condition called monoclonal gammopathy, additional confirmation of ATTR-CA may be needed.
History of heart failure. This means you have been hospitalized for heart failure before or have signs of heart failure, such as swelling, shortness of breath, or fluid in the lungs, even if you haven't been hospitalized for it.
If you are taking heart-related medications, except for diuretics (water pills), your doses should be stable. This means no more than a 50% change in dose and no changes in the medications you take for at least 2 weeks before the study starts.

Who cannot join the trial?

7 criteria

Patients who are not diagnosed with ATTR Cardiac Amyloidosis. This is a condition where abnormal proteins build up in the heart.
Patients who are not within the specified age range for the study.
Patients who do not belong to the clinical trial group specified for this study.
Patients who are not able to safely participate in exercise tests.
Patients who are pregnant or breastfeeding.
Patients who have other serious health conditions that might interfere with the study.
Patients who are unable to give informed consent to participate in the study.

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Verified sites

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Fondazione Toscana Gabriele Monasterio
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Pisa, Italy

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Investigated drugs

Dapagliflozin is a medication that helps the body get rid of extra sugar through urine. It is often used to treat diabetes by lowering blood sugar levels. In this clinical trial, dapagliflozin is being tested to see if it can improve the quality of life and exercise capacity in patients with a heart condition called amyloid transthyretin cardiac amyloidosis. This condition affects the heart's ability to function properly, and researchers want to find out if dapagliflozin can help patients feel better and be more active.

Dapagliflozin

What is already known about the treatment

Dapagliflozin – Dapagliflozin is a medication taken orally, usually in the form of a tablet, and is currently being studied for its effects on patients with ATTR Cardiac Amyloidosis, a condition affecting the heart. It is already known in medical literature for its use in managing diabetes and heart failure, but this study aims to explore its potential benefits in improving exercise capacity and quality of life for those with this specific heart condition. Dapagliflozin works by helping the kidneys remove glucose from the bloodstream, which can also have beneficial effects on heart function. It belongs to a class of drugs known as SGLT2 inhibitors, which are primarily used to lower blood sugar levels in people with type 2 diabetes.

Investigated diseases

ATTR Cardiac Amyloidosis – ATTR Cardiac Amyloidosis is a condition where abnormal protein deposits, known as amyloid, accumulate in the heart tissue. This buildup can cause the heart walls to become stiff, affecting the heart's ability to pump blood effectively. Over time, this can lead to symptoms such as fatigue, shortness of breath, and swelling in the legs and abdomen. The disease progresses as the amyloid deposits increase, further impairing heart function. As the heart struggles to maintain normal circulation, patients may experience worsening symptoms and reduced exercise capacity. The condition is considered rare and can significantly impact daily activities and quality of life.