Heart Failure
Conditions
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.
Interventions
None listed
Sponsors
Richmond Research Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To generate high quality ECG data to establish an ECG library for the development of an ECG tool to monitor disease progression. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United Kingdom
Contacts
CONTACTVolunteer Recruitment Team
PRINCIPAL_INVESTIGATORPrincipal Investigator
Richmond Pharmacology
Outcome results
None listed