Clinical trial NCT05035459: B-lines-guided Heart Failure Management in Heart Failure Patients
Official title: Impact of B-lines-guided Intensive Heart Failure Management on Outcome of Discharged Heart Failure Patients With Residual B-lines
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Ultrasound
Heart Failure
Keywords: subclinical heart failure
B-line
pulmonary congestion
outcome
Lead sponsor: Xiangtan Central Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient volunteered for the trial.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome consisted of readmission for worsening heart failure, or death during follow-up.
timeFrame: The patients will be followed up for 1 year after they were discharged from the hospital.
Secondary outcomes:
measure: Change the Duke Activity Status Index (DASI) score
timeFrame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
measure: Change in NT-proBNP
timeFrame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
measure: Change in 6-minute walk distance values (6MWD)
timeFrame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
measure: Change in arrythmia
timeFrame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Other outcomes:
measure: Safety outcome
timeFrame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Locations:
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
Study officials:
References:
citation: 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.
citation: 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.