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

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03262571
Enrollment
244
Registered
2017-08-25
Start date
2010-12-31
Completion date
2016-03-31
Last updated
2017-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Heart failure, Lung ultrasound, B-lines

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.

Interventions

DIAGNOSTIC_TESTLung ultrasound

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

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

(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.

Exclusion criteria

(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.

Design outcomes

Primary

MeasureTime frameDescription
Reduction of hospitalizations for acute decompensated heart failure90 daysSignificant reduction of hospitalizations for acute decompensated heart failure in group A during the 90-day follow-up period.

Secondary

MeasureTime frameDescription
Natriuretic peptides values90 daysSignificant reduction of natriuretic peptides values in group A during the 90-day follow-up period.
Quality of life test (QLT) score90 daysSignificant reduction of QTL score in group A during the 90-day follow-up period.
Cardiac mortality90 daysSignificant reduction of cardiac mortality rate in group A versus group B.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026