Study to Collect High-Resolution ECG Data and Patient Insights on Heart Failure Care
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-80
SponsorRichmond Research Institute
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
General public who meet the inclusion/exclusion criteria
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction
Trial outcomes
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.
Time frame
18 monthsSecondary 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
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.
Time frame
18 monthsOther outcomes
1
To gather participant feedback on the design of future heart failure trials.
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.
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov