At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Telemonitoring service (combination product)
- How long the study runs
- Study runs about 35 months (dates as stated)
- About the drug or intervention
- Telemonitoring service — combination product: Patients in the active arm will receive a cellular network connected set of digital scales, and instructed to take their weight each morning at the same time.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 320
- Started
- 2025-01-01
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for cardiac amyloidosis
- • NA - 320 participants
- • Cardiac amyloidosis is a condition where the heart muscle, amongst other tissues, is infiltrated by the abnormal build-up of proteins called amyloid
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with cardiac amyloidosis
Where?
- • London - Richmond Research Institute
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Adults aged ≥18 at the date of signing agreement to take part which is defined as the beginning of the Screening Period.
- ✓An established diagnosis of ATTR cardiomyopathy as defined by protocol.
- ✓An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- ✓Currently a patient at a study site (NAC).
Who cannot take part
- ✗An inability to have or use BodyTrace device scales at usual residence (for example no mobile network cellular signal)
- ✗On dialysis or end-stage kidney failure (eGFR \<25mL/min)
- ✗Serum albumin \<20g/dL or other non-hypervolaemia cause of tissue oedema (e.g. protein-losing enteropathy, nephrotic...
- ✗Use of greater than 2 oral diuretics (e.g. on maximum oral diuretic therapy)
See the full criteria
Where Is This Study? (1 UK site)
Richmond Research Institute
London SW17 0RE, United Kingdom
How to Get in Touch
James Rickard, MPharm
Sponsor contactCONTACT
Keith Berelowitz
Sponsor contactCONTACT