Ignite Creation Date:
2024-05-06 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05035459
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2021-08-25
Brief Title:
B-lines-guided Heart Failure Management in Heart Failure Patients
Sponsor:
Xiangtan Central Hospital
Organization:
Xiangtan Central Hospital
Study Overview
Official Title:
Impact of B-lines-guided Intensive Heart Failure Management on Outcome of Discharged Heart Failure Patients With Residual B-lines
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMP-OUTCOME
Brief Summary:
BackgroundAbout 50 of subclinical heart failure Sub-HF patients might have residual lung ultrasound B-lines LUS-BL Sub-HF is insensitive to widely used imaging examinations like x-ray or echocardiography but lung ultrasound LUS can sufficiently detect pulmonary congestion in Sub-HF patients Previous studies showed that residual LUS-BL is associated worse clinical outcome among patients with chronic heart failure In this trial we sought to evaluate the impact of LUS-BL guided intensive HF management post discharge in patients with residual LUS-BL on outcome up to 1 year after discharge
Aim IMP-OUTCOME is a prospective single-center observational cohort study which is designed to investigate whether LUS-BL-guided intensive HF management post discharge might improve the outcome of HF patients with residual B-lines at discharge up to 1 year after discharge
Methods and results After receiving the standardized treatment of HF according to current guidelines 320 HF patients with 3 B-lines LUS-BL assessed within 48 hours before discharge will be divided into the conventional HF management group and the LUS-BL-guided intensive HF management group at 11 ratio LUS-BL-guided intensive HF management group will receive optimized HF medication according to current guidelines and medication will be adjusted according the status of LUS-BL in addition to symptom and physical examination results during the follow-up at 2-month interval Patient-related clinical data including sex age blood chemistry imaging examination drug utilization and so on will be obtained and analyzed Following discharge from the hospital patients in the conventional HF management group will receive optimized HF medication according to current guidelines and medication will be adjusted without knowing the status of LU-BL during the follow-up at 2-month interval LUS-BL will be assessed at 2-month interval post discharge in both groups results will be transferred to HF nurses who will decide to present the LUS-BL results to managing cardiologist or envelope the LUS-BL results till study end according to group assignment Echocardiography examination will be performed at 12 months for all patients and EF Ee LA size and systolic pulmonary artery pressure will be assessed The primary endpoint is the composite of re-hospitalization for worsening HF and all-cause death during follow-up Secondary endpoints include the change in the Duke Activity Status Index DASI and NT-pro BNP arrythmia and 6-minutes walk distance at each follow up EF and B-lines changes at final follow up Safety profile will be noted and analyzed Primary results will be available by early 2024
Conclusion This trial will clarify the impact of LUS-BL guided intensive HF management on outcome for discharged patients with residual B-lines up to 1 year after discharge in the era of sodium-glucose cotransporter-2 inhibitors and angiotensin receptor blocker-neprilysin inhibitor
Aim IMP-OUTCOME is a prospective single-center observational cohort study which is designed to investigate whether LUS-BL-guided intensive HF management post discharge might improve the outcome of HF patients with residual B-lines at discharge up to 1 year after discharge
Methods and results After receiving the standardized treatment of HF according to current guidelines 320 HF patients with 3 B-lines LUS-BL assessed within 48 hours before discharge will be divided into the conventional HF management group and the LUS-BL-guided intensive HF management group at 11 ratio LUS-BL-guided intensive HF management group will receive optimized HF medication according to current guidelines and medication will be adjusted according the status of LUS-BL in addition to symptom and physical examination results during the follow-up at 2-month interval Patient-related clinical data including sex age blood chemistry imaging examination drug utilization and so on will be obtained and analyzed Following discharge from the hospital patients in the conventional HF management group will receive optimized HF medication according to current guidelines and medication will be adjusted without knowing the status of LU-BL during the follow-up at 2-month interval LUS-BL will be assessed at 2-month interval post discharge in both groups results will be transferred to HF nurses who will decide to present the LUS-BL results to managing cardiologist or envelope the LUS-BL results till study end according to group assignment Echocardiography examination will be performed at 12 months for all patients and EF Ee LA size and systolic pulmonary artery pressure will be assessed The primary endpoint is the composite of re-hospitalization for worsening HF and all-cause death during follow-up Secondary endpoints include the change in the Duke Activity Status Index DASI and NT-pro BNP arrythmia and 6-minutes walk distance at each follow up EF and B-lines changes at final follow up Safety profile will be noted and analyzed Primary results will be available by early 2024
Conclusion This trial will clarify the impact of LUS-BL guided intensive HF management on outcome for discharged patients with residual B-lines up to 1 year after discharge in the era of sodium-glucose cotransporter-2 inhibitors and angiotensin receptor blocker-neprilysin inhibitor
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None