B-lines-guided Heart Failure Management in Heart Failure Patients (IMP-OUTCOME)

January 29, 2024 updated by: Jianping Zeng, Xiangtan Central Hospital

Impact of B-lines-guided Intensive Heart Failure Management on Outcome of Discharged Heart Failure Patients With Residual B-lines

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Xiangtan, Hunan, China, 411100
        • Xiangtan Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The patient volunteered for the trial.

Description

Inclusion Criteria:

Hospitalized heart failure patients with objective heart failure evidence during or before hospitalization.

New York Heart Association (NYHA) class II, III, or IV.

Patients with NT-proBNP level of at least 600pg/meal (or ≥400 pg/meal if they had been hospitalized for heart failure within the previous 12 months). Atrial fibrillation or atrial flutter patients with NT-proBNP level of at least 900 pg/ml, regardless of their history of HF hospitalization.

Exclusion Criteria:

Exclusion criteria included patients with life expectancy less than 1 year due to malignancy. Patients with ARDS and pneumonia. Patients with interstitial lung disease/pulmonary fibrosis and patients on dialysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: lung ultrasound
drug adjustment based on lung ultrasound results
Other Names:
  • intensive HF management
LU-BL guided intensive heart failure management group
The group 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 LUS-BL-guided intensive heart failure management group will receive optimized HF medication and medication will be adjusted according the status of LUS-BL during the follow-up at 2-month interval.
Diagnostic test: lung ultrasound
drug adjustment based on lung ultrasound results
Other Names:
  • intensive HF management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome consisted of readmission for worsening heart failure, or death during follow-up.
Time Frame: The patients will be followed up for 1 year after they were discharged from the hospital.
follow-up by clinical visit
The patients will be followed up for 1 year after they were discharged from the hospital.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change the Duke Activity Status Index (DASI) score
Time Frame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
The scale consists of 12 items covering major daily physical activities such as living, housework, walking, sexual function, and recreation, and patients are judged to be able to complete the activity content by themselves. Each entry has a different score based on the weight it takes to expend on exercise energy, with the scale summing from 0 to 58.2, with higher scores representing better physical activity status.
Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Change in NT-proBNP
Time Frame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
pg/ml
Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Change in 6-minute walk distance values (6MWD)
Time Frame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
walk distance (meter)
Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Change in arrythmia
Time Frame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
ECG results will be evaluated and arrythmia will be evaluated
Baseline, 2, 4, 6, 8, 10 and 12 months post discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety outcome
Time Frame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
  • number of hospitalisation for hypotension
  • number of hospitalisation for worsening of renal function
  • number of hyperkalaemia
  • number of hypokalaemia
  • number of worsening of renal function
  • number of ketoacidosis
  • number of drug allergy
  • number of lower limb edema
  • number of severe liver dysfunction
  • number of hypoglycemia
Baseline, 2, 4, 6, 8, 10 and 12 months post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangtan Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2022

Primary Completion (Actual)

May 25, 2023

Study Completion (Estimated)

May 25, 2024

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XiangtanCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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