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

NCT06809686 | Recruiting

• 1 other identifier: C24042
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  18 months

Other Outcomes (1)

• To gather participant feedback on the design of future heart failure trials.

  18 months

Study Arms (1)

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

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

General public who meet the inclusion/exclusion criteria

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Richmond Research Institute: lead

Study Sites (2)

Richmond Pharmacology

London, London, SE1 1YR, United Kingdom

RECRUITING

Richmond Pharmacology

London, London, SE1 1YR, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 34649282 BACKGROUND

• 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.

  PMID: 34447992 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Haematology, coagulation, biochemistry Serology (HIV 1 and 2, Hepatitis B \& C) COVID-19 and Influenza test

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Principal Investigator

  Richmond Pharmacology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Volunteer Recruitment Team

CONTACT

+44 (0) 207 042 5800; volunteer@richmondpharmacology.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): January 21, 2027
• Study Completion (Estimated): February 21, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

GB (2)