RecruitingNAINTERVENTIONAL

PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY

This study, called PATHWAY-RCT, is for people with a heart condition called cardiac amyloidosis. In this condition, abnormal proteins build up in the heart, making it stiff and less efficient, which can lead to heart failure and often means hospital stays. There’s currently no specific treatment, apart from water tablets to manage fluid. This study wants to see if regularly checking your weight at home and talking to a doctor by phone if your weight goes up (a sign of fluid build-up) can prevent you from needing to go to hospital. Researchers believe this 'telemonitoring' could help manage the condition better, based on earlier positive results. They will compare this home monitoring approach to standard care.

At a glance

Status

Recruiting

Phase

Sponsor

Richmond Research Institute

Enrolment target

320

Start

01 Jan 2025

Estimated completion

01 Dec 2026

Cardiac Amyloidosis

What is this study about?

Cardiac amyloidosis is a condition where tiny, abnormal protein bits called amyloid build up in your heart muscle. This makes your heart stiff and thick over time, meaning it can't pump blood as well as it should. This extra strain can lead to heart failure. The most common type, especially in older people, is called 'wild-type' ATTR amyloidosis.

People with this condition often end up in hospital because of its effects. In fact, after diagnosis, there's a 60% chance each year that someone with ATTR amyloidosis will need to go to hospital. Right now, there aren't many treatments for ATTR amyloidosis itself, other than using 'water tablets' (diuretics) to help reduce extra fluid in the body and stop it from building up in places like the lungs.

One of the most reliable ways to spot this fluid building up is if your body weight increases. This study is looking into a different approach called 'telemonitoring'. This means checking your health from a distance, like at home. The researchers want to see if regularly weighing yourself at home and then speaking to a doctor over the phone if your weight goes up can help catch fluid build-up early. They hope this could stop you from needing to go into hospital. They will compare this new way of monitoring to the usual care you would receive.

Key takeaways

The study explores home weight monitoring to prevent hospital visits for cardiac amyloidosis.
It targets 'wild-type' ATTR cardiac amyloidosis, common in elderly patients.
Regular weight checks help detect early fluid build-up.
Doctors will discuss concerns via phone if weight increases.
The study compares home monitoring with standard medical care.
It aims to improve management and reduce hospital admissions.

Who may be eligible?

To be part of this study, you need to be an adult aged 18 or over and have a confirmed diagnosis of ATTR cardiac amyloidosis. You must also be able to understand and agree to the study rules and be a patient at the National Amyloidosis Centre (NAC).

There are some reasons why you might not be able to join. For example, if you can't use the special weighing scales at your home (perhaps due to poor mobile phone signal), or if you are on dialysis or have very severe kidney problems.

You also can't join if you have very low blood protein levels (serum albumin less than 20g/dL) or other reasons for fluid swelling that aren't related to too much fluid in your body, such as certain bowel or kidney conditions. Lastly, if you are already taking more than two types of water tablets (diuretics) to manage your fluid, you would not be 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 18 years old or older?
Do you have a confirmed diagnosis of ATTR cardiac amyloidosis?
Are you currently a patient at the National Amyloidosis Centre (NAC)?
Can you use a special weighing scale at your home (e.g., do you have mobile signal)?
Are you currently NOT on dialysis or don't have very severe kidney problems?
Are you taking two or fewer types of 'water tablets' for fluid management?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves is not fully provided in this summary. However, based on the brief description, participation would involve regularly weighing yourself at home using a special device. If your weight increases, which could suggest fluid build-up, you would then have a telephone discussion with a doctor for advice and management. The study will compare this home monitoring approach with the usual care you would receive. The total duration of the study is not specified here.

Potential risks and benefits

Potential benefits could include improved monitoring of your condition, with earlier detection of fluid build-up, which might help prevent hospital stays. There's also the benefit of more frequent communication with doctors if concerns arise. Potential risks are generally low, as the intervention is telemonitoring (home weight checks) rather than a new medication. There might be some inconvenience of regular weight checks and phone calls. Remember, you have the right to withdraw from the study at any time.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Richmond Research Institute
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is cardiac amyloidosis?

It's a heart condition where abnormal proteins build up in the heart muscle, making it stiff and less able to pump blood efficiently.

What does 'telemonitoring' mean?

It means checking your health or medical signs from a distance, often using technology like special home devices and phone calls with doctors.

Why is checking my weight important in this study?

An increase in body weight can be a reliable sign of fluid building up in your body due to your heart condition, which the study aims to catch early.

Will I get a new medicine if I join?

This study focuses on monitoring your condition, not testing new medicines. The intervention is regularly weighing yourself and having telephone discussions with a doctor if needed.

What is 'usual care' in this study?

Usual care refers to the standard medical attention and treatments you would normally receive for your condition, without the specific home telemonitoring involved in the study.

How to find out more

James Rickard, MPharm

j.rickard@richmondresearchinstitute.org +44 02070425800 Official trial record

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