Acute Decompensated Heart FailureNCT06243029
A Study to Assess Multidomain Endpoints of an ECG Patch
An observational study of Acute Decompensated Heart Failure, run by AstraZeneca at 3 sites in United Kingdom.
Trial summary
This study aims to evaluate the utility of a wearable heart monitoring patch that can be worn on the body to collect various measurements related to heart failure and develop a concept to potentially be used as a new measurement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- ECG Patch
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 8 Jan 2024to 13 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Potential study participants will be identified through review of hospital inpatient lists, conversations with healthcare providers and review of medical notes. Participants who meet the study eligibility criteria will be approached whilst still in the hospital but due to be discharged by the research team who will enquire whether they are interested in participating in the study. Up to 80 male and female participants over 18 years old will be enrolled in the study.
Who may be able to join
- Men and women aged 18 years or older
- Confirmed diagnosis of heart failure according to the latest ESC criteria
- Primary cause of hospitalisation due to decompensated heart failure
- Willing and able to complete all visits and assessments as per protocol
- Provision of signed and dated, written informed consent before any study-specific procedures.
Who cannot join
- Receiving renal replacement therapy
- Implanted cardiac (or other) device in-situ, cardiac pacemaker, defibrillator, or other implanted electronic devices or other ventricular assist device in situ
- Currently receiving chemotherapy
- Receiving end-of-life care
- Active severe infection: individuals with an active severe infection, as determined by the PI's clinical judgment, will not be eligible for study participation
- Hypersensitivity to patch adhesive/ materials in the patch
- Skin condition or damage that prevents wearing of the patch.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Research Site
Cambridge, CB2 0QQ
Research Site
Harefield, UB9 6JH
Research Site
Leicester, LE3 9PQ
About this study
Official title: Clinical Observational Study of Remote, Non-invasive, Multidomain Endpoints in Patients Recovering From Acute Decompensated Heart Failure
This study aims to evaluate the utility of a wearable heart monitoring patch that can be worn on the body to collect various measurements related to heart failure and develop a concept to potentially be used as a new measurement. It is crucial to test out new ways that make it easier to do research for new drugs and increase our chances of knowing how well they will work early on in the development process. Results from this study will be useful in planning future development programs for drugs aimed at treating patients with heart disease.
This study will be conducted in three hospitals, it is non-randomised (not chosen by chance), exploratory, study in the United Kingdom. It aims to involve up to 80 men and women recently admitted due to sudden, severe heart failure symptoms. Participants will be part of the study for about two months, with one hospital visit after discharge, as commonly done in heart failure centres.
- Visit 1 (Pre-Screening/Screening/Enrolment) will assess the participant's eligibility for participating in the study and for collecting data following hospitalisation for acute decompensated heart failure (ADHF). Participants will be trained and receive an ECG patch to wear from that moment onwards at home for a period of 4 to 7 days.
- Visit 2 (Follow-up visit) will be conducted approximately 6-8 weeks post Visit 1 and this will be the final study-related site visit. Participants will receive an ECG patch to wear at home for a second time for a period of 4 to 7 days.
- Review of Medical Records: It is a review of the health status using medical records by the study team. The participant is not expected to attend the hospital for any appointments
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- ECG Patch
- Keywords
- Acute Decompensated Heart Failure;, Heart Failure;, ECG Patch
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG PatchDevice
Wearable ECG Patch designed to record and transmit physiological parameters to a mobile device or a data cloud. The device stores data locally in a memory cache designed for >96 hours of continuous data. It continuously records a one-lead ECG and has a three-axis accelerometer. On-board algorithms use those data to compute heart rate, heart rate variability, RR-interval, respiratory rate, and an activity level indicator. The company also provides optional arrhythmia detection and reporting services, the results of which may be delivered to healthcare professionals.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patch-measured variables between baseline and follow-up at 6-8 weeks (multiple variables) using the ECG patch.
Measured: 6-8 weeks
Secondary outcomes (5)
Data completeness overall and per ECG patch variable, participant adherence, signal to noise ratio, day versus night assessment of quality using the ECG patch.
Measured: 6-8 weeks
Correlation between a change in ECG patch variables (multiple) and change in KCCQ at 6-8 weeks after discharge from hospital following admission for ADHF.
Measured: 6-8 weeks
Correlation between clinical parameters e.g. NT-pro BNP, KCCQ, BP, HR and the patch variables using data from Visit 1 (multiple comparisons).
Measured: 6-8 weeks
Correlation between change in NT-proBNP, BP, HR, body weight, peripheral oedema extent, NYHA class etc. and change in the patch variables (multiple comparisons).
Measured: 6-8 weeks
Correlation between change in one minute sit to stand test, frailty score, hand grip test and the change in patch variables (multiple comparisons).
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start8 Jan 2024
- Primary completion13 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof Iain Squire, BSc MBChB MD, Principal investigator, Glenfield Hospital, University Hospitals of Leicester NHS TrustDr Owais Dar, MD PhD, Principal investigator, Royal Brompton & Harefield Hospitals,Guy's and St Thomas' Foundation TrustDr Joseph Cheriyan, MD PhD, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243029
- Sponsor's protocol ID
- D1840M00072
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2023
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observational Study of Remote, Non-invasive, Multidomain Endpoints in Patients Recovering From Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT06243029
- Acronym / sponsor ID
- D1840M00072
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Acute Decompensated Heart Failure;, Heart Failure;, ECG Patch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 6 Feb 2024 (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.
This study aims to evaluate the utility of a wearable heart monitoring patch that can be worn on the body to collect various measurements related to heart failure and develop a concept to potentially be used as a new measurement. It is crucial to test out new ways that make it easier to do research for new drugs and increase our chances of knowing how well they will work early on in the development process. Results from this study will be useful in planning future development programs for drugs aimed at treating patients with heart disease.
This study will be conducted in three hospitals, it is non-randomised (not chosen by chance), exploratory, study in the United Kingdom. It aims to involve up to 80 men and women recently admitted due to sudden, severe heart failure symptoms. Participants will be part of the study for about two months, with one hospital visit after discharge, as commonly done in heart failure centres.
- Visit 1 (Pre-Screening/Screening/Enrolment) will assess the participant's eligibility for participating in the study and for collecting data following hospitalisation for acute decompensated heart failure (ADHF). Participants will be trained and receive an ECG patch to wear from that moment onwards at home for a period of 4 to 7 days.
- Visit 2 (Follow-up visit) will be conducted approximately 6-8 weeks post Visit 1 and this will be the final study-related site visit. Participants will receive an ECG patch to wear at home for a second time for a period of 4 to 7 days.
- Review of Medical Records: It is a review of the health status using medical records by the study team. The participant is not expected to attend the hospital for any appointments
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential study participants will be identified through review of hospital inpatient lists, conversations with healthcare providers and review of medical notes. Participants who meet the study eligibility criteria will be approached whilst still in the hospital but due to be discharged by the research team who will enquire whether they are interested in participating in the study. Up to 80 male and female participants over 18 years old will be enrolled in the study.
Key inclusion criteria (5 listed)
- Men and women aged 18 years or older
- Confirmed diagnosis of heart failure according to the latest ESC criteria
- Primary cause of hospitalisation due to decompensated heart failure
- Willing and able to complete all visits and assessments as per protocol
- Provision of signed and dated, written informed consent before any study-specific procedures.
Key exclusion criteria (7 listed)
- Receiving renal replacement therapy
- Implanted cardiac (or other) device in-situ, cardiac pacemaker, defibrillator, or other implanted electronic devices or other ventricular assist device in situ
- Currently receiving chemotherapy
- Receiving end-of-life care
- Active severe infection: individuals with an active severe infection, as determined by the PI's clinical judgment, will not be eligible for study participation
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 |
|---|---|---|
| ECG PatchWearable ECG Patch designed to record and transmit physiological parameters to a mobile device or a data cloud. The device stores data locally in a memory cache designed for >96 hours of continuous data. It continuously records a one-lead ECG and has a three-axis accelerometer. On-board algorithms use those data to compute heart rate, heart rate variability, RR-interval, respiratory rate, and an activity level indicator. The company also provides optional arrhythmia detection and reporting services, the results of which may be delivered to healthcare professionals. | Device | – |
Primary outcome
Change in patch-measured variables between baseline and follow-up at 6-8 weeks (multiple variables) using the ECG patch.
Time frame: 6-8 weeks
5 secondary outcomes
Data completeness overall and per ECG patch variable, participant adherence, signal to noise ratio, day versus night assessment of quality using the ECG patch.
Time frame: 6-8 weeks
Correlation between a change in ECG patch variables (multiple) and change in KCCQ at 6-8 weeks after discharge from hospital following admission for ADHF.
Time frame: 6-8 weeks
Correlation between clinical parameters e.g. NT-pro BNP, KCCQ, BP, HR and the patch variables using data from Visit 1 (multiple comparisons).
Time frame: 6-8 weeks
Correlation between change in NT-proBNP, BP, HR, body weight, peripheral oedema extent, NYHA class etc. and change in the patch variables (multiple comparisons).
Time frame: 6-8 weeks
Correlation between change in one minute sit to stand test, frailty score, hand grip test and the change in patch variables (multiple comparisons).
Time frame: 6-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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. This study is not recruiting at the moment.
Prof Iain Squire, BSc MBChB MD principal investigator
Glenfield Hospital, University Hospitals of Leicester NHS Trust
Dr Owais Dar, MD PhD principal investigator
Royal Brompton & Harefield Hospitals,Guy's and St Thomas' Foundation Trust
Dr Joseph Cheriyan, MD PhD principal investigator
Cambridge University Hospitals NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Decompensated Heart Failure, run by AstraZeneca at 3 sites 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 7 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: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patch-measured variables between baseline and follow-up at 6-8 weeks (multiple variables) using the ECG patch. (time frame: 6-8 weeks). 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 25 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.