Clinical Trial

PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY

Study acronym: PATHWAY-RCT
Recruiting
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Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-10-15; most recent amendment 2026-06-15.
Status change: Not Yet Recruiting → Recruiting 2025-09-29
Trial Details
NCT Number NCT05098665
Lead Sponsor Richmond Research Institute
Collaborators: Richmond Pharmacology Limited, National Amyloidosis Centre
Conditions Cardiac Amyloidosis
Enrollment 320 participants
Start Date 2025-01-01
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-16