Clinical trial NCT05098665: PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY
Official title: PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY Using Remote Cardiac Telemonitoring
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Amyloidosis
Lead sponsor: Richmond Pharmacology Limited
Sponsor class: INDUSTRY
Collaborators: name: Richmond Pharmacology Limited
name: National Amyloidosis Centre
First posted: 2021-10-28
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial of telemonitoring intervention versus usual care
Primary purpose: PREVENTION

Brief summary: 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.


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)

Primary outcomes:
measure: Heart-failure related hospitalisations
timeFrame: Study duration (3 years)
measure: All-cause mortality
timeFrame: Study duration (3 years)
Secondary outcomes:
measure: All-cause hospitalisation
timeFrame: Study duration (3 years)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Richmond Research Institute
Study officials:
affiliation: National Amyloidosis Centre, Royal Free Hospital
name: Tamer Rezk, MBBS MRCP PhD
role: PRINCIPAL_INVESTIGATOR
References: