B-lines-guided Heart Failure Management in Heart Failure Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-25

Study Completion Date

2024-08-25

Brief Summary

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Background：About 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 1:1 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, E/e', 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.

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Detailed Description

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Conditions

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Lung Ultrasound Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conventional heart failure management group

Patients with ≥ 3 B-lines will be divided into the conventional heart failure management group and the LUS-BL-guided intensive heart failure management group at 1:1 ratio. Patients in the conventional heart failure management group will receive conventional guideline recommended HF therapy post discharge and be followed up at 2-month interval post discharge by clinical visit. LUS-BL will be assessed at 2-month interval post discharge also in this group, but results will be enveloped.