Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649435
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Photoplethysmography Signal Differences Between Heart Failure Patients and Healthy Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Photoplethysmography Signal Differences Between Heart Failure Patients and Healthy Population
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPG-HF
Brief Summary:
Heart failure HF affects approximately 1-2 of adult population in developed countries In the population over 70 years it is even more common with prevalence over 10 Despite significant progress in both diagnostics and treatment based on the principles of evidence-based medicine associated morbidity and mortality remains high Depending on patient condition 12-month all-cause mortality reaches 17 and up to 44 of patients require hospitalization within 12 months
Underdiagnosis of HF is common as early detection is often hampered by the lack of specificity of symptoms limited access to echocardiography and the presence of comorbidities resulting in substantial false positives and negatives
Underdiagnosis of HF is common as early detection is often hampered by the lack of specificity of symptoms limited access to echocardiography and the presence of comorbidities resulting in substantial false positives and negatives
Detailed Description:
Non-invasive and widely available diagnostic tool would be a great advantage in management of HF patients One method that could potentially meet these criteria is photoplethysmography PPG PPG is a non-invasive measurement and is a standard part of a medical examination This data can be used to train a diagnostic algorithm for HF detection Such solution would be widely available cheap easily scalable and would enable screening and early detection of the disease in a wide population
The investigators hypothesize that there are significant differences in time and frequency domain characteristics of the PPG signal between HF patients and healthy volunteers Null hypothesis is that there will be no significant differences in time and frequency domain characteristics of the PPG signal between HF patients and healthy volunteers
The investigators hypothesize that there are significant differences in time and frequency domain characteristics of the PPG signal between HF patients and healthy volunteers Null hypothesis is that there will be no significant differences in time and frequency domain characteristics of the PPG signal between HF patients and healthy volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None