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Smart scales could keep heart amyloidosis patients out of hospital

NCT ID NCT05098665

Disease control Sponsor: Richmond Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether daily weight monitoring at home can reduce hospitalizations for heart failure in people with cardiac amyloidosis, a condition where protein buildup stiffens the heart. 320 adults with ATTR cardiomyopathy will either use a connected scale that alerts doctors if fluid builds up, or receive usual care. The goal is to see if early detection of weight gain (a sign of fluid overload) can prevent serious complications and deaths.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Remote cardiac telemonitoring service (digital scales and clinical algorithm)
What this could lead to
If successful, this could provide a simple, low-cost way to keep people with cardiac amyloidosis out of the hospital and improve their quality of life.
What could go wrong
This is a relatively small trial (320 people) testing a monitoring approach, not a new drug. It may not show a clear benefit over usual care, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults aged ≥18 at the date of signing informed consent which is defined as the beginning of the Screening Period. 2. An established diagnosis of ATTR cardiomyopathy as defined by protocol. 3. Ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (R2) (2016) and applicable regulations, before completing any study-related procedures. 4. An understanding, ability, and willingness to fully comply with study procedures and restrictions. 5. Currently a patient at a study site (NAC). Exclusion Criteria: 1. An inability to have or use BodyTrace device scales at usual residence (for example no mobile network cellular signal) 2. On dialysis or end-stage renal failure (eGFR \<25mL/min) 3. Serum albumin \<20g/dL or other non-hypervolaemia cause of tissue oedema (e.g. protein-losing enteropathy, nephrotic syndrome) 4. Use of greater than 2 oral diuretics (e.g. on maximum oral diuretic therapy)

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial amyloidosis wild type ATTR amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac amyloidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Richmond Research Institute

    RECRUITING

    London, London, SW17 0RE, United Kingdom

More trials for these conditions

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