Preventing hospital admission for ATTR cardiomyopathy with home telemonitoring

PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY Using Remote Cardiac Telemonitoring

This will test whether a home telemonitoring service using daily weight scales can reduce hospital admissions for adults with ATTR cardiac amyloidosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Richmond Pharmacology Limited (Industry-sponsored)
• Locations: 1 site (London)
• Trial ID: NCT05098665 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with an established diagnosis of ATTR cardiomyopathy who can consent, are under care at the participating centre, and can use BodyTrace scales with mobile connectivity are eligible.

Not a fit: Patients on dialysis or with end-stage renal failure, those with low serum albumin or other non-fluid causes of swelling, people unable to use or connect the scales at home, or those excluded for high diuretic use are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the telemonitoring approach could lower the number of hospital admissions by catching fluid build-up earlier and enabling timely outpatient treatment.

How similar studies have performed: Telemonitoring has previously reduced admissions and mortality in general heart failure populations, but there is limited published evidence specifically in ATTR cardiomyopathy.

Eligibility criteria

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 this trial is running

London

• Richmond Research Institute — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Tamer Rezk, MBBS MRCP PhD — National Amyloidosis Centre, Royal Free Hospital
• Study coordinator: James Rickard, MPharm

Conditions Cardiac Amyloidosis