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

Last updated: March 18, 2025
Sponsor: Richmond Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Hyponatremia

Chest Pain

Treatment

N/A

Clinical Study ID

NCT06809686
C24042
  • Ages 45-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Diagnosed with heart failure.

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

Exclusion

Exclusion Criteria:

  1. Diagnostic test results positive for:

  2. HIV-1 or HIV-2 infection

  3. Hepatitis B or Hepatitis C infection

  4. Mental incapacity, language barriers or unwillingness to comply with therequirements of the protocol, which may preclude adequate understanding orcooperation during the study as judged by the Investigator.

  5. Any condition judged by the Investigator to pose an undue risk while participatingin the trial

  6. Diagnostic results which are inconsistent with heart failure with mildly reduced orpreserved ejection fraction as judged by the Investigator.

Study Design

Total Participants: 1000
Study Start date:
February 05, 2025
Estimated Completion Date:
February 21, 2027

Study 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.

Connect with a study center

  • Richmond Pharmacology

    London, SE1 1YR
    United Kingdom

    Active - Recruiting

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