Study to Collect High-Resolution ECG Data and Patient Insights on Heart Failure Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: 45 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (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 [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United Kingdom · 2 centers
- Richmond Pharmacology — London
- Richmond Pharmacology — London
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 Gu PMID 34649282
- 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; ESC Scientific Document Gro PMID 34447992
Identifiers
NCT: NCT06809686 · C24042