Preventing hospital admission for ATTR cardiomyopathy with home telemonitoring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial provides patients with remote monitoring equipment (BodyTrace weight scales) to record daily body weight at home, with data sent to a clinical monitoring team. The service is intended to detect early fluid retention so clinicians can intervene (for example by adjusting diuretics) before problems require hospital admission. Participants are adults with established ATTR cardiomyopathy who can use the equipment and have mobile connectivity, and they remain under care at the study site. Key outcomes include rates of hospital admission for heart failure and feasibility of the telemonitoring pathway.

Why it matters

Who can join: the full rules

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)

Where it's running

• Richmond Research Institute
  London, London, United Kingdom Recruiting

Study contacts

• Principal investigator: Tamer Rezk, MBBS MRCP PhD — National Amyloidosis Centre, Royal Free Hospital
• Study coordinator: James Rickard, MPharm
• Email: j.rickard@richmondresearchinstitute.org
• Phone: +44 02070425800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.