Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593223
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Non-invasive Filling PressureNIFP Device Based on Low Frequency Heart Sound in Assessment of Congestion in Heart Failure Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Non-invasive Filling PressureNIFP Device Based on Low Frequency Heart Sound in Assessment of Congestion in Heart Failure Patients
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
Congestion plays a key role in heart failure HF trajectory Clinical congestion refers to the signs and symptoms resulting from elevated cardiac filling pressures Hemodynamic congestion refers to elevated cardiac filling pressures which may occur days or weeks before the presentation of symptoms
Serial assessment of congestion is required in each encounter of the HF patients while in current clinical practice serial assessment of congestion relies on physical examination sometimes supported by BNP test Both physical and BNP test are reported to be unreliable in some cases Echocardiography is good tool but it requires skilled physician to operation and is more time consuming In general there is unmet needs of better tools for serial assessment of congestion in HF patient management
In this study we aim to prospectively observe and evaluate the feasibility of using a novel non-invasive device in assessment of congestion in HF patients
Serial assessment of congestion is required in each encounter of the HF patients while in current clinical practice serial assessment of congestion relies on physical examination sometimes supported by BNP test Both physical and BNP test are reported to be unreliable in some cases Echocardiography is good tool but it requires skilled physician to operation and is more time consuming In general there is unmet needs of better tools for serial assessment of congestion in HF patient management
In this study we aim to prospectively observe and evaluate the feasibility of using a novel non-invasive device in assessment of congestion in HF patients
Detailed Description:
None
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