Study to Collect High-Resolution ECG Data and Patient Insights on Heart Failure Care

NCT ID: NCT06809686

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2027-02-21

Brief 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 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.

Conditions

Heart Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Male or female participants aged 45 to 80 years (inclusive) at the date of signing the informed consent.

2. Diagnosed with heart failure.

3. Able and willing to provide informed consent to participate.

Exclusion Criteria

1. Diagnostic test results positive for:

1. HIV-1 or HIV-2 infection

2. Hepatitis B or Hepatitis C infection

2. 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.

3. Any condition judged by the Investigator to pose an undue risk while participating in the trial

4. Diagnostic results which are inconsistent with heart failure with mildly reduced or preserved ejection fraction as judged by the Investigator.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Richmond Research Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

Richmond Pharmacology

Locations

Richmond Pharmacology

London, London, United Kingdom

Site Status: RECRUITING

Richmond Pharmacology

London, London, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Volunteer Recruitment Team

Role: CONTACT

volunteer@richmondpharmacology.com

+44 (0) 207 042 5800

Facility Contacts

Volunteer Recruitment Team

Role: primary

volunteer@richmondpharmacology.com

+44 (0) 20 7042 5800

Volunteer Recruitment

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 34649282 (View on PubMed)

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 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.

Reference Type: BACKGROUND

PMID: 34447992 (View on PubMed)

Other Identifiers

C24042

Identifier Type: -

Identifier Source: org_study_id