PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telemonitoring service.
- Who it may be relevant to
- Registry conditions: Cardiac Amyloidosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY Using Remote Cardiac Telemonitoring
Overview
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
- Combination product Telemonitoring service
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. This device (BodyTrace) automatically uploads each daily weight reading to a central database. A clinical algorithm is applied to detect those at risk of acute and subacute decompensated heart failure. Patients are contacted within 24-48 hours of being flagged as at risk by a heart failure specialist. A clinical history is taken, and medic
Primary outcome measures
- Heart-failure related hospitalisations [Time frame: Study duration (3 years)]
- All-cause mortality [Time frame: Study duration (3 years)]
Secondary outcome measures (1)
- All-cause hospitalisation [Time frame: Study duration (3 years)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United Kingdom · 1 center
- Richmond Research Institute — London
Identifiers
NCT: NCT05098665 · C21026