Heart FailureNCT06809686
Study to Collect High-Resolution ECG Data and Patient Insights on Heart Failure Care
An observational study of Heart Failure, run by Richmond Research Institute at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to establish an electrocardiogram (ECG) data library to facilitate future studies on heart disease. Additionally, the study will be used to monitor changes in the patient's standard of care throughout the study period and gather patient perspectives on routine diagnostic procedures and… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Heart Failure
- How many people
- 1,000 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 5 Feb 2025to 21 Feb 2027
- Phase
- Observational
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General public who meet the inclusion/exclusion criteria
Who may be able to join
- Male or female participants aged 45 to 80 years (inclusive) at the date of signing the informed consent.
- Diagnosed with heart failure.
- Able and willing to provide informed consent to participate.
Who cannot join
- Diagnostic test results positive for:
- HIV-1 or HIV-2 infection
- Hepatitis B or Hepatitis C infection
- Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or cooperation during the study as judged by the Investigator.
- Any condition judged by the Investigator to pose an undue risk while participating in the trial
- Diagnostic results which are inconsistent with heart failure with mildly reduced or preserved ejection fraction as judged by the Investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Richmond Pharmacology
London, London, SE1 1YR
Volunteer Recruitment Team, +44 (0) 20 7042 5800, volunteer@richmondpharmacology.com
- Recruiting
Richmond Pharmacology
London, London, SE1 1YR
Volunteer Recruitment
About this study
Official title: An Observational Study to Collect High Resolution 12-Lead Electrocardiogram (ECG) Data for the Development of an ECG Library to Support the Development of a Tool to Monitor Disease Progression, Gather Patient Perspectives on Standard of Care Heart Failure Procedures and Facilitate Familiarity With the Clinical Trial Environment in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
The purpose of this study is to establish an electrocardiogram (ECG) data library to facilitate future studies on heart disease. Additionally, the study will be used to monitor changes in the patient's standard of care throughout the study period and gather patient perspectives on routine diagnostic procedures and disease monitoring and feedback on the design of heart failure trials.
Read the detailed description
Patients with heart failure with mildly reduced or preserved ejection fraction will be invited to participate in this patient observational study.
After providing informed consent, participants will then undergo a series of clinical assessments, and the participants' ECGs will be used to contribute to establishing an ECG library for future heart disease research. Additionally, patients' perspectives on the current standard of care clinical procedures will be gathered. Patient preferences will be gathered in relation to factors around routine clinical investigations for heart failure to better design a disease monitoring tool to include clinical and patient preferences. Also, the patients may be updated on the latest therapy options.
Additionally, participants may be invited to review and provide feedback on the study design of heart failure trials under development, helping to ensure alignment with patient needs. Their input can identify potential procedure challenges and enhance the clarity of study materials, improving overall patient engagement. A follow-up call with a research physician will provide the opportunity to discuss any issues identified in the clinical baseline assessment and allow the participant to ask any additional questions.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction | Study to Collect High Resolution 12-Lead Electrocardiogram (ECG) Data for the Development of an ECG Library to Support the Development of a Tool to Monitor Disease Progression, Gather Patient Perspectives on Standard of Care Heart Failure Procedures and Facilitate Familiarity with the Clinical Trial Environment in Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
To generate high quality ECG data to establish an ECG library for the development of an ECG tool to monitor disease progression.
After providing informed consent, participants will then undergo a series of clinical assessments, and the participants' ECGs will be used to contribute to establishing an ECG library for future heart disease research.
Measured: 18 months
Secondary outcomes (1)
To gather patient perspectives on the current standard of care heart failure management and procedures. • To gather patient perspectives on preferences related to undergoing clinical diagnostics with the aim of improving the design of a disease monitor
Patients' perspectives on the current standard of care clinical procedures will be gathered. Patient preferences will be gathered in relation to factors around routine clinical investigations for heart failure to better design a disease monitoring tool to include clinical and patient preferences. Also, the patients may be updated on the latest therapy options.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start5 Feb 2025
- Primary completion21 Jan 2027 (estimated)
- Study completion21 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richmond Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, Principal investigator, Richmond Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809686
- Sponsor's protocol ID
- C24042
- Status last verified
- May 2026
- First submitted
- 30 Jan 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study publication when completed
Publications
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A. Corrigendum to: 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2021 Dec 21;42(48):4901. doi: 10.1093/eurheartj/ehab670. No abstract available.
PubMed 34649282McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
PubMed 34447992
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Collect High Resolution 12-Lead Electrocardiogram (ECG) Data for the Development of an ECG Library to Support the Development of a Tool to Monitor Disease Progression, Gather Patient Perspectives on Standard of Care Heart Failure Procedures and Facilitate Familiarity With the Clinical Trial Environment in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT06809686
- Acronym / sponsor ID
- C24042
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Richmond Research InstituteIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 21 Jan 2027 (estimated)
- Study completion
- 21 Feb 2027 (estimated)
- First posted
- 5 Feb 2025 (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.
The purpose of this study is to establish an electrocardiogram (ECG) data library to facilitate future studies on heart disease. Additionally, the study will be used to monitor changes in the patient's standard of care throughout the study period and gather patient perspectives on routine diagnostic procedures and disease monitoring and feedback on the design of heart failure trials.
Detailed description
Patients with heart failure with mildly reduced or preserved ejection fraction will be invited to participate in this patient observational study.
After providing informed consent, participants will then undergo a series of clinical assessments, and the participants' ECGs will be used to contribute to establishing an ECG library for future heart disease research. Additionally, patients' perspectives on the current standard of care clinical procedures will be gathered. Patient preferences will be gathered in relation to factors around routine clinical investigations for heart failure to better design a disease monitoring tool to include clinical and patient preferences. Also, the patients may be updated on the latest therapy options.
Additionally, participants may be invited to review and provide feedback on the study design of heart failure trials under development, helping to ensure alignment with patient needs. Their input can identify potential procedure challenges and enhance the clarity of study materials, improving overall patient engagement. A follow-up call with a research physician will provide the opportunity to discuss any issues identified in the clinical baseline assessment and allow the participant to ask any additional questions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction | – | –Study to Collect High Resolution 12-Lead Electrocardiogram (ECG) Data for the Development of an ECG Library to Support the Development of a Tool to Monitor Disease Progression, Gather Patient Perspectives on Standard of Care Heart Failure Procedures and Facilitate Familiarity with the Clinical Trial Environment in Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General public who meet the inclusion/exclusion criteria
Key inclusion criteria (3 listed)
- Male or female participants aged 45 to 80 years (inclusive) at the date of signing the informed consent.
- Diagnosed with heart failure.
- Able and willing to provide informed consent to participate.
Key exclusion criteria (6 listed)
- Diagnostic test results positive for:
- Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or cooperation during the study as judged by the Investigator.
- Any condition judged by the Investigator to pose an undue risk while participating in the trial
- Diagnostic results which are inconsistent with heart failure with mildly reduced or preserved ejection fraction as judged by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To generate high quality ECG data to establish an ECG library for the development of an ECG tool to monitor disease progression.
Time frame: 18 months
After providing informed consent, participants will then undergo a series of clinical assessments, and the participants' ECGs will be used to contribute to establishing an ECG library for future heart disease research.
1 secondary outcome
To gather patient perspectives on the current standard of care heart failure management and procedures. • To gather patient perspectives on preferences related to undergoing clinical diagnostics with the aim of improving the design of a disease monitor
Time frame: 18 months
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 20 May 2026.
- Background: PubMed 34649282McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A. Corrigendum to: 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2021 Dec 21;42(48):4901. doi: 10.1093/eurheartj/ehab670. No abstract available.
- Background: PubMed 34447992McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
- Individual participant dataSharing planned: Undecided. Study publication when completed
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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.
Principal Investigator principal investigator
Richmond Pharmacology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Richmond Research Institute at 2 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 3 inclusion and 6 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 Volunteer Recruitment Team (+44 (0) 207 042 5800, volunteer@richmondpharmacology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To generate high quality ECG data to establish an ECG library for the development of an ECG tool to monitor disease progression. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06809686, which also lists 2 linked publications.
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 20 May 2026.