Usefulness of Lung Ultrasound in Ambulatory Management of Patients With Chronic Heart Failure

NCT03262571 | Terminated Phase 3 DMC

• 1 other identifier: B-LINES
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose. The aim of this study is to evaluate whether lung ultrasound, in addition to physical examination, leads to a reduction of the admission rate for acute decompensated heart failure of patients with chronic heart failure (HF) followed in the outpatients heart failure clinic. Methods. This is a prospective randomized study. The planned sample size consists of 440 patients with chronic HF. The inclusion criteria are: (1) male and female aged between 18 and 90 years (2) signed written informed consent (3) history of HF for at least six months, (4) left ventricular ejection fraction \< 45%, (5) adequate medical therapy for HF for at least two months. The exclusion criteria are: (1) concomitant enrollment in other clinical studies, or treatment with experimental drugs or devices within 30 days of clinical assessment, (2) inability to undergo to the planned follow-up and procedures (3) documented pulmonary infections (3) interstitial lung disease and class 4 chronic obstructive pulmonary disease according to GOLD classification. Patients are randomized in two groups: group A, patients undergoing to lung ultrasound and physical examination; and group B, patients undergoing to physical examination only. Patients are evaluated at baseline and after three months with medical history, Quality of Life test, physical examination, blood sample for hematochemical (creatinine, electrolytes, BNP/NTpro-BNP). The diuretic therapy is then optimized according to the presence and severity of B-lines in group A and physical examination in group B. Only patients enrolled in group A undergo to a lung ultrasound examination to assess the extent of pulmonary congestion, through its evidence of B-lines. B-lines originate from the contrast between air-filled structures and water-thickened pulmonary interlobular septa. This leads to linear echogenic vertical artefacts that spread from the pleural layers downwards in the screen. The ultrasound examination is performed with a handheld echocardiography device. The physician carries out a scan of the pulmonary fields, from basal towards mid and apical fields, through the midaxillary line while the patient lies supine. The quantification of B-lines is performed according to their extent over the lung fields. All the information are recorded in dedicated forms. The results are evaluated according to the following criteria. The primary end-point is a significant reduction of hospitalizations for acute decompensated HF in group A during the follow-up period. The secondary end-points are changes of NT-proBNP values, quality of life test (QLT) score and cardiac mortality.

Conditions

Chronic Heart Failure; Lung; Congestive; Acute Decompensated Heart Failure

Keywords

Heart failure; Lung ultrasound; B-lines

Outcome Measures

Primary Outcomes (1)

• Reduction of hospitalizations for acute decompensated heart failure

  Significant reduction of hospitalizations for acute decompensated heart failure in group A during the 90-day follow-up period.

  90 days

Secondary Outcomes (3)

• Natriuretic peptides values

  90 days

• Quality of life test (QLT) score

  90 days

• Cardiac mortality

  90 days

Study Arms (2)

Group A

EXPERIMENTAL

Group A includes patients undergoing lung ultrasound and physical examination.

Diagnostic Test: Lung ultrasound

Group B

PLACEBO COMPARATOR

Group B includes patients undergoing physical examination only.

Diagnostic Test: Lung ultrasound

Interventions

Lung ultrasound DIAGNOSTIC_TEST

Duretic therapy is then optimized according to the presence and severity of B-lines in group A.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) male and female aged between 18 and 90 years (2) signed written informed consent (3) history of HF for at least six months, (4) left ventricular ejection fraction \< 45%, (5) adequate medical therapy for HF for at least two months.

You may not qualify if:

• (1) concomitant enrollment in other clinical studies, or treatment with experimental drugs or devices within 30 days of clinical assessment, (2) inability to undergo to the planned follow-up and procedures (3) documented pulmonary infections (4) interstitial lung disease, class 4 chronic obstructive pulmonary disease according to GOLD guidelines (5) chronic dialysis.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: December 1, 2010
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 25, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)