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

Heart Failure Clinical Trial

— IMP-OUTCOME  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05035459
• Other study ID #: XiangtanCH
• Status: Active, not recruiting
• Start date: March 25, 2022
• Est. completion date: May 25, 2024

Study information

• Verified date: January 2024
• Source: Xiangtan Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: May 25, 2024
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Lung Ultrasound

Intervention

Diagnostic Test:
• lung ultrasound
drug adjustment based on lung ultrasound results
• Lung ultrasound
drug adjustment independent on lung ultrasound results

Locations

Country	Name	City	State
China	Xiangtan Central Hospital	Xiangtan	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangtan Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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;3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety outcome	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
Primary	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	Change the Duke Activity Status Index (DASI) score	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
Secondary	Change in NT-proBNP	pg/ml	Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Secondary	Change in 6-minute walk distance values (6MWD)	walk distance (meter)	Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Secondary	Change in arrythmia	ECG results will be evaluated and arrythmia will be evaluated	Baseline, 2, 4, 6, 8, 10 and 12 months post discharge