Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05098665

PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY

Led by Richmond Research Institute · Updated on 2025-10-03

320

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

Sponsors

R

Richmond Research Institute

Lead Sponsor

R

Richmond Pharmacology Limited

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged �3e=18 at the date of signing informed consent
  • Established diagnosis of ATTR cardiomyopathy as defined by protocol
  • Ability to provide written informed consent before any study procedures
  • Understanding and willingness to comply with study procedures and restrictions
  • Currently a patient at a study site (NAC)
Not Eligible

You will not qualify if you...

  • Inability to have or use BodyTrace device scales at usual residence (e.g., no mobile cellular signal)
  • On dialysis or end-stage renal failure (eGFR <25mL/min)
  • Serum albumin <20g/dL or other non-fluid related causes of tissue swelling
  • Use of more than 2 oral diuretics (maximum oral diuretic therapy)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Richmond Research Institute

London, United Kingdom, SW17 0RE

Actively Recruiting

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Research Team

J

James Rickard, MPharm

CONTACT

K

Keith Berelowitz

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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