Cardiac AmyloidosisPATHWAY-RCTNCT05098665
PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY
A study testing Telemonitoring service in people with Cardiac Amyloidosis, run by Richmond Research Institute at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- Telemonitoring service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 at the date of signing informed consent which is defined as the beginning of the Screening Period.
- An established diagnosis of ATTR cardiomyopathy as defined by protocol.
- 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.
- An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- Currently a patient at a study site (NAC).
Who cannot join
- An inability to have or use BodyTrace device scales at usual residence (for example no mobile network cellular signal)
- On dialysis or end-stage renal failure (eGFR <25mL/min)
- Serum albumin <20g/dL or other non-hypervolaemia cause of tissue oedema (e.g. protein-losing enteropathy, nephrotic syndrome)
- Use of greater than 2 oral diuretics (e.g. on maximum oral diuretic therapy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Richmond Research Institute
London, London, SW17 0RE
Dominic Pimenta, MBBS MRCP BSc (Hons), grants@richmondresearchinstitute.org
Jorg Taubel, MD FFPM
About this study
Official title: PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY Using Remote Cardiac Telemonitoring
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
- Cardiac Amyloidosis
- Being tested
- Telemonitoring service
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring serviceCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - RCT telemonitoring | Active comparator | 160 ATTR-CM patients assigned to receive telemonitoring intervention Receives: Combination Product: Telemonitoring service |
| Arm B - RCT usual care | No intervention | Control group of 160 ATTR-CM patients assigned to receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart-failure related hospitalisations
Hospitalisation which can be attributed to heart failure
Measured: Study duration (3 years)
All-cause mortality
Death by any cause, as an annual event rate
Measured: Study duration (3 years)
Secondary outcomes (1)
All-cause hospitalisation
Hospitalisation for any reason
Measured: Study duration (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Jan 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial of telemonitoring intervention versus usual care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richmond Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited, National Amyloidosis Centre
- Responsible party
- Sponsor
- Investigators
- Tamer Rezk, MBBS MRCP PhD, Principal investigator, National Amyloidosis Centre, Royal Free Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098665
- Sponsor's protocol ID
- C21026
- Acronym
- PATHWAY-RCT
- Status last verified
- Mar 2026
- First submitted
- 15 Oct 2021
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of personal data with other organisations is not planned
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PATHWAY-RCT: Preventing Admission To Hospital With Attr cardiomyopathY Using Remote Cardiac Telemonitoring
- ClinicalTrials.gov ID
- NCT05098665
- Acronym / sponsor ID
- PATHWAY-RCT / C21026
- Conditions
- Cardiac Amyloidosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Richmond Research InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited, National Amyloidosis Centre
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial of telemonitoring intervention versus usual care
| Arm | Type | Receives |
|---|---|---|
| Arm A - RCT telemonitoring | Active comparator | Combination Product: Telemonitoring service160 ATTR-CM patients assigned to receive telemonitoring intervention |
| Arm B - RCT usual care | No intervention | –Control group of 160 ATTR-CM patients assigned to receive usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged ≥18 at the date of signing informed consent which is defined as the beginning of the Screening Period.
- An established diagnosis of ATTR cardiomyopathy as defined by protocol.
- 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.
- An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- Currently a patient at a study site (NAC).
Key exclusion criteria (4 listed)
- An inability to have or use BodyTrace device scales at usual residence (for example no mobile network cellular signal)
- On dialysis or end-stage renal failure (eGFR <25mL/min)
- Serum albumin <20g/dL or other non-hypervolaemia cause of tissue oedema (e.g. protein-losing enteropathy, nephrotic syndrome)
- Use of greater than 2 oral diuretics (e.g. on maximum oral diuretic therapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemonitoring servicePatients 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. | Combination product | Arm A - RCT telemonitoring |
Primary outcome
Heart-failure related hospitalisations
Time frame: Study duration (3 years)
Hospitalisation which can be attributed to heart failure
All-cause mortality
Time frame: Study duration (3 years)
Death by any cause, as an annual event rate
1 secondary outcome
All-cause hospitalisation
Time frame: Study duration (3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. Sharing of personal data with other organisations is not planned
Related trials for Cardiac Amyloidosis
Active, not recruitingObservational study
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ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
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EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
Transthyretin Amyloid Cardiomyopathy
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Essen Amyloidosis Registry
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A Phase 3 Study of NTLA-2001 in ATTRv-PN
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MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tamer Rezk, MBBS MRCP PhD principal investigator
National Amyloidosis Centre, Royal Free Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring service in people with Cardiac Amyloidosis, run by Richmond Research Institute at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Rickard, MPharm (+44 02070425800, j.rickard@richmondresearchinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart-failure related hospitalisations (time frame: Study duration (3 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.