PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY

Cardiac Amyloidosis Clinical Trial

— PATHWAY-RCT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05098665
• Other study ID #: C21026
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: December 2026

Study information

• Verified date: April 2023
• Source: Richmond Pharmacology Limited
• Contact: Dominic Pimenta, MBBS MRCP BSc (Hons)
• Phone: 02070425800
• Email: grants[@]richmondresearchinstitute.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis
• Cardiomyopathies

Intervention

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 medication review undertaken, in line with a protocol. Diuretics are adjusted as per the protocolised changes, or for patients at ceiling of treatment, referral for local specialist review is made. A third protocol for follow-up is then followed to close the loop of intervention.

Locations

Country	Name	City	State
United Kingdom	Richmond Research Institute	London

Sponsors (3)

Lead Sponsor	Collaborator
Dr Jorg Taubel	National Amyloidosis Centre, Richmond Pharmacology Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart-failure related hospitalisations	Hospitalisation which can be attributed to heart failure	Study duration (3 years)
Primary	All-cause mortality	Death by any cause, as an annual event rate	Study duration (3 years)
Secondary	All-cause hospitalisation	Hospitalisation for any reason	Study duration (3 years)