PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY (NCT05098665) | Clinical Trial Compass
RecruitingNot Applicable
PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY
United Kingdom320 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on preventing hospital admissions and death from cardiac amyloidosis — how does my current condition compare to the kinds of patients being enrolled, and is it worth discussing whether I might be a candidate?
2Since this trial is listed as Phase NA, which can mean it's testing a care pathway or management strategy rather than a new drug, can you explain exactly what intervention or approach is being tested, and how that differs from the standard care I'd receive if I didn't join?
3The trial is measuring heart-failure related hospitalisations and all-cause mortality as its main outcomes — what does that tell us about how serious my situation is, and whether the approach being studied here addresses my most pressing risks?
4Given that this trial is actively recruiting right now, what would participation actually look like for me day-to-day — how many visits, tests, or changes to my routine would be involved, and is that realistic given my current health?
5Are there existing approved treatments for cardiac amyloidosis, like tafamidis or other therapies, that I should be considering first, or alongside this trial, before deciding whether enrolling here is the right next step?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.