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Clinical Trial Summary

Background:About 50% of subclinical heart failure (Sub-HF) patients might have residual lung ultrasound B-lines (LU-BL). Sub-HF is insensitive to widely used imaging examinations, like x-ray or echocardiography, but lung ultrasound (LU) can sufficiently detect pulmonary congestion in Sub-HF patients. In this trial, we sought to evaluate the impact of residual B-lines at discharge and other clinical findings of heart failure (HF) patients on rehospitalization due to HF and all-cause mortality (composite primary outcome) up to 1 year post discharge. The impact of intensive HF therapy post discharge on outcome up to 1 year after discharge will also be investigated. Aim: IMP-OUTCOME is a prospective, single-center, observational cohort study, which is designed to investigate whether residual LU-BL at discharge are the determinants of poor outcome in Sub-HF patients and if intensive HF therapy post discharge might improve the outcome of sub-HF patients with residual B-lines up to 1 year after discharge. Methods and results: After receiving the standardized treatment of HF according to current guidelines, 233 HF patients with improved signs and symptoms of HF would be grouped into < 3 B-lines and ≥ 3 B-lines groups according to LU-BL measurement within 48 hours before discharge, and the group with ≥ 3 B-lines will be further divided into the conventional therapy group and the intensive therapy group at 1:1 ratio. Intensive therapy group will be treated with SGLT2 inhibitor beyond other medications and regularly monitored by HF nurses and cardiologists at 1 month interval. Patient-relates basic, 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 will be followed up at 1 month, 3 months, 6 months, and 1 year by clinical visit or telephone call. 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 and 6-min walk distance change. Up to the end of 2022, approximately 233 HF patients will be enrolled. Follow up is expected to be completed around the end of 2023, and primary results will be available by early 2024. Conclusion: This trial will clarify the impact of residual B-lines on outcome of discharged HF patients and the impact of intensive HF management in discharged patients with residual B-lines up to 1 year after discharge.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05035459
Study type Observational
Source Xiangtan Central Hospital
Contact Jianping Zeng
Phone +86 15292271982
Email [email protected]
Status Not yet recruiting
Phase
Start date September 1, 2021
Completion date January 1, 2024

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