ClinicalTrials.gov record NCT05098665

PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY Using Remote Cardiac Telemonitoring

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationUnited Kingdom
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized trial compares home weight telemonitoring with usual care in adults with ATTR cardiomyopathy. The telemonitoring arm uses cellular-connected digital scales that upload daily weights; an algorithm flags at-risk readings and a heart-failure specialist contacts flagged patients within 24–48 hours to review symptoms and medicines. Primary outcomes include heart-failure hospitalisations and all-cause mortality measured over a three-year study period.

What it is studying. The study tests whether a telemonitoring service—daily home weight measurements uploaded by cellular-connected scales, automated flagging, and a protocolised clinician response including diuretic adjustments or specialist referral—has a different effect on heart-failure hospitalisations and all-cause mortality compared with usual care in people with ATTR cardiomyopathy.

What the researchers hope to learn. To compare telemonitoring with usual care for adults with ATTR cardiomyopathy by measuring heart-failure-related hospitalisations and all-cause mortality (primary outcomes) and all-cause hospitalisation (secondary outcome), and to generate prospective evidence about using daily weight uploads and an algorithm-driven clinical response in this population.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Cardiac amyloidosis is a condition where the heart muscle, amongst other tissues, is infiltrated by the abnormal build-up of proteins called amyloid. This stiffens and thickens the heart muscle over time which makes it less efficient and puts further stress and strain on the other chambers of the heart, leading to heart failure. The commonest form, that affects predominantly the elderly, is called 'wild-type' ATTR amyloid (TTR is the protein that accumulates). In this condition a patient has a 60% chance of admission to hospital each year after diagnosis. There is no current treatment for ATTR amyloid other than using water tablets to reduce excess fluid and prevent more serious fluid build up in lungs and other tissues. Increasing body weight is the most reliable clinical sign of this fluid build up. Tele-monitoring is the practice of monitoring patients from a distance and has been shown to reduce heart failure admissions and death in patients with heart failure from any cause. Due to reduced access to primary and secondary care during COVID-19 the investigators instigated tele-monitoring of heart failure in ATTR amyloid patients. This appeared to be an effective intervention in the pilot study. The investigators propose to monitor the weight of patients with cardiac amyloidosis at home and intervene where a build up of fluid is observed by telephone discussion with a doctor. The investigators propose to evidence this in a prospective clinical trial. The investigators will evaluate the effect fairly by comparing tele-monitoring with usual care.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Combination product
  • Telemonitoring service

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Adults aged ≥18 at the date of signing informed consent which is defined as the beginning of the Screening Period.
  • An established diagnosis of ATTR cardiomyopathy as defined by protocol.
  • 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.
  • An understanding, ability, and willingness to fully comply with study procedures and restrictions.
  • Currently a patient at a study site (NAC).

Exclusion criteria

  • An inability to have or use BodyTrace device scales at usual residence (for example no mobile network cellular signal)
  • On dialysis or end-stage renal failure (eGFR <25mL/min)
  • Serum albumin <20g/dL or other non-hypervolaemia cause of tissue oedema (e.g. protein-losing enteropathy, nephrotic syndrome)
  • Use of greater than 2 oral diuretics (e.g. on maximum oral diuretic therapy)

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomly assigned to either a telemonitoring service or to usual care. Those in the telemonitoring arm receive a cellular-network connected digital scale (BodyTrace), are asked to weigh themselves each morning, and have daily weight readings uploaded to a central database; an algorithm flags people at risk. If flagged, a heart-failure specialist will contact the participant within 24–48 hours to take a clinical history, review medications, adjust diuretics per protocol, or refer for local specialist review, with follow-up to close the loop. The study requires an established diagnosis of ATTR cardiomyopathy and the ability to have/use the BodyTrace scales at your usual residence (for example, have mobile cellular signal); people on dialysis or end-stage renal failure (eGFR <25 mL/min), with serum albumin <20 g/dL or other non-hypervolemic causes of tissue oedema, or using more than two oral diuretics are excluded per the registry.

How the study is structured. Participants are randomly assigned to one of two parallel groups: telemonitoring or usual care. The telemonitoring group receives BodyTrace cellular scales and is asked to weigh daily; readings upload to a central database, an algorithm flags at-risk weights, and a heart-failure specialist contacts flagged patients within 24–48 hours to take a clinical history and review medications following study protocols. The record lists masking as 'SINGLE' but does not specify who is masked. Primary outcomes are followed over a three-year study duration.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Cardiac Amyloidosis. Does it apply to my diagnosis?
  • The listed sites are in United Kingdom. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 1, 2025
Primary completion
December 2027 (estimated)
Study completion
December 2027 (estimated)
Target enrollment
320 participants (estimated)
Last updated on registry
Jun 16, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Richmond Research Institute
Collaborators
  • Richmond Pharmacology Limited
  • National Amyloidosis Centre

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

usual care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Screening Period
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
eGFR
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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