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

NCT05035459 | Active Not Recruiting

• 1 other identifier: XiangtanCH
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Ultrasound; Heart Failure

Keywords

subclinical heart failure; B-line; pulmonary congestion; outcome

Outcome Measures

Primary Outcomes (1)

• The primary outcome consisted of readmission for worsening heart failure, or death during follow-up.

  follow-up by clinical visit

  The patients will be followed up for 1 year after they were discharged from the hospital.

Secondary Outcomes (4)

• Change the Duke Activity Status Index (DASI) score

  Baseline, 2, 4, 6, 8, 10 and 12 months post discharge

• Change in NT-proBNP

  Baseline, 2, 4, 6, 8, 10 and 12 months post discharge

• Change in 6-minute walk distance values (6MWD)

  Baseline, 2, 4, 6, 8, 10 and 12 months post discharge

• Change in arrythmia

  Baseline, 2, 4, 6, 8, 10 and 12 months post discharge

Other Outcomes (1)

• Safety outcome

  Baseline, 2, 4, 6, 8, 10 and 12 months post discharge

Study Arms (2)

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

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

Interventions

Lung ultrasound DIAGNOSTIC_TEST

drug adjustment based on lung ultrasound results

Also known as: intensive HF management

Conventional heart failure management group; LU-BL guided intensive heart failure management group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patient volunteered for the trial.

You may qualify if:

• 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.

Sponsors & Collaborators

• Xiangtan Central Hospital: lead

Study Sites (1)

Xiangtan Central Hospital

Xiangtan, Hunan, 411100, China

Location

Related Publications (2)

• Platz E, Lewis EF, Uno H, Peck J, Pivetta E, Merz AA, Hempel D, Wilson C, Frasure SE, Jhund PS, Cheng S, Solomon SD. Detection and prognostic value of pulmonary congestion by lung ultrasound in ambulatory heart failure patients. Eur Heart J. 2016 Apr 14;37(15):1244-51. doi: 10.1093/eurheartj/ehv745. Epub 2016 Jan 26.

  PMID: 26819225 RESULT

• Zhu Y, Li N, Wu M, Peng Z, Huang H, Zhao W, Yi L, Liao M, Liu Z, Peng Y, Zhou Y, Lu J, Li G, Zeng J. Impact of B-lines-guided intensive heart failure management on outcome of discharged heart failure patients with residual B-lines. ESC Heart Fail. 2022 Aug;9(4):2713-2718. doi: 10.1002/ehf2.13988. Epub 2022 May 20.

  PMID: 35595501 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, Xiangtan Central Hospital ,Director of cardiovascular clinic, Clinical Professor

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 5, 2021
• Study Start: March 25, 2022
• Primary Completion: May 25, 2023
• Study Completion: August 25, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)