Actively Recruiting
PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY
Led by Richmond Research Institute · Updated on 2025-10-03
320
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
R
Richmond Research Institute
Lead Sponsor
R
Richmond Pharmacology Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged �3e=18 at the date of signing informed consent
- Established diagnosis of ATTR cardiomyopathy as defined by protocol
- Ability to provide written informed consent before any study procedures
- Understanding and willingness to comply with study procedures and restrictions
- Currently a patient at a study site (NAC)
You will not qualify if you...
- Inability to have or use BodyTrace device scales at usual residence (e.g., no mobile cellular signal)
- On dialysis or end-stage renal failure (eGFR <25mL/min)
- Serum albumin <20g/dL or other non-fluid related causes of tissue swelling
- Use of more than 2 oral diuretics (maximum oral diuretic therapy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Richmond Research Institute
London, United Kingdom, SW17 0RE
Actively Recruiting
Research Team
J
James Rickard, MPharm
CONTACT
K
Keith Berelowitz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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