RecruitingPHASE1, PHASE2INTERVENTIONAL

Genistein in trAnSthyretin recePtor Amyloid caRdiomyopathy

This study is investigating a natural plant extract called genistein, which comes from soybeans, for people with a heart condition called Amyloid Cardiomyopathy. This condition affects how well your heart works. The main goals are to find out if genistein is safe to use and if it can help reduce inflammation, which is like swelling inside the body. We also want to see if it improves how well the heart pumps blood and your ability to walk. Participants will take genistein by mouth, and doctors will take blood samples and perform heart scans and walking tests to measure any changes. This information will help us understand if genistein could be a helpful treatment in the future.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

Start

27 Sep 2024

Estimated completion

01 Dec 2025

Amyloid Cardiomyopathy

What is this study about?

This study is about a heart problem called Amyloid Cardiomyopathy. In this condition, abnormal protein — called amyloid — builds up in the heart muscle, making it stiff and harder for the heart to pump blood effectively. This can lead to symptoms like tiredness and breathlessness. We are testing a natural substance called genistein, which comes from soybeans. We want to see if genistein can help people with this specific type of heart condition. The study is particularly interested in how genistein might reduce inflammation (internal swelling) and improve heart function, as inflammation is known to play a part in heart problems.

This is an early-stage study, meaning it's one of the first times genistein is being tested in people for this condition. We'll be looking closely at its safety and how well it's tolerated. We'll also examine whether it can improve certain markers in the blood that show inflammation or heart strain. In addition to blood tests, we'll check how well the heart is working using special scans and measure how far people can walk in six minutes, which helps us understand their general fitness and heart health.

The information we gather from this study, although relatively small with 40 participants, is very important. It will help us decide if genistein is promising enough to conduct larger studies in the future. Ultimately, the goal is to find new and effective ways to help people living with Amyloid Cardiomyopathy and improve their quality of life. This research could open doors to better treatments for heart failure in general.

Key takeaways

This study investigates a natural extract (genistein from soybeans) for a heart condition called Amyloid Cardiomyopathy.
It aims to check safety, reduce inflammation, and improve heart function and walking ability.
Participants will take genistein by mouth for 12 weeks, with doses increasing over time.
Assessments include blood tests, heart scans, and a 6-minute walk test.
The total study duration for each participant is about 18 weeks.
Information from this study will help decide if genistein can be explored in larger studies.

Who may be eligible?

To join this study, you would typically need to be between 40 and 80 years old. You must have been diagnosed with Amyloid Cardiomyopathy and currently be managing your heart failure with stable medication doses for at least three months, with no recent changes.

Some things might mean you can't take part. This includes if you are pregnant, have certain other health conditions like some cancers (or a strong family history), endometriosis, or uterine fibroids. You also can't be on a vegan diet or already taking similar supplements that contain genistein or related substances. Issues with your liver or kidney function, uncontrolled diabetes, certain blood disorders, or recent hospital stays (not related to heart failure) would also prevent you from joining.

Also, if you have severe alcohol use, allergies to genistein or specific dyes used in heart scans, or have mild or very severe heart failure symptoms (NYHA Class I or IV), you wouldn't be able to participate. The study aims to find people with a specific range of symptoms and health conditions to get the most accurate results.

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 40 and 80 years old?
Have you been diagnosed with Amyloid Cardiomyopathy?
Are your heart failure medications stable for the last 3 months?
Are you currently not pregnant or planning to be?
Do you have good kidney and liver function?
Are you able to attend regular appointments for blood tests and heart scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given genistein as tablets to take by mouth. You'll start with a lower dose (two 250mg tablets per day for 4 weeks), then the dose will increase (two 500mg tablets per day for 4 weeks), and finally, it will increase again (two 750mg tablets per day for another 4 weeks). This means you'll be taking genistein for a total of 12 weeks, with increasing doses.

Throughout the study, you'll have several visits for assessments. Doctors will take blood samples at the beginning, during each dose increase, and after you stop taking the medication. These blood tests will check your general health and specific markers related to inflammation and your heart. You'll also have heart scans (echocardiograms) to see how your heart is working and perform a 6-minute walk test. After you finish taking genistein for 12 weeks, there will be a 6-week period where you don't take the study medication (this is called a 'washout period'), and some final checks will be done. The entire study participation, from enrolment to the end of the washout period, will last about 18 weeks.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of joining this study is that genistein might help your heart condition by reducing inflammation and improving heart function, though this is not guaranteed for everyone. It could also provide valuable information that helps others in the future. Potential risks might include side effects from the genistein medication, which will be carefully monitored. There are also discomforts associated with blood tests and medical examinations. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

London Regional Health Science Centre
Verified postcode
London, Canada· Recruiting

Common questions

What is Amyloid Cardiomyopathy?

It's a heart condition where abnormal proteins build up in the heart, making it stiff and harder to pump blood effectively.

What is genistein?

Genistein is a natural substance found in soybeans that the study hopes might help reduce inflammation in the body.

How long will I take genistein for?

You will take genistein by mouth for a total of 12 weeks, with the dose gradually increasing over that time.

What tests will I have?

You'll have regular blood tests, heart scans (echocardiograms), and a 6-minute walk test to check your heart health and fitness.

Is this a new treatment?

This is an early-stage study (Phase 1b/2a) to understand if genistein is safe and effective for this condition, so it's not a common treatment yet.

How to find out more

Mark JK Chandy, MD PhD

mark.chandy@lhsc.on.ca 5196612111 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.