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PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY

RecruitingNAAges 18 Years - anyAllRichmond Research Institute
NCT05098665 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 sh

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adults aged ≥18 at the date of signing informed consent which is defined as the beginning of the Screening Period. 2. An established diagnosis of ATTR cardiomyopathy as defined by protocol. 3. 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. 4. An understanding, ability, and willingness to fully comply with study procedures and restrictions. 5. Currently a patient at a study site (NAC). Exclusion Criteria: 1. An inability to have or use BodyTrace device scales at usual residence (for example no mobile network cellular signal) 2. On dialysis or end-stage renal failure (eGFR \<25mL/min) 3. Serum albumin \<20g/dL or other non-hypervolaemia cause of tissue oedema (e.g. protein-losing enteropathy, nephrotic syndrome) 4. Use of greater than 2 oral diuretics (e.g. on maximum oral diuretic therapy)
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What it tests

  • Telemonitoring service
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Where

1 site
Richmond Research Institute
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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