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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03262571
Recruitment Status : Terminated (Because at the interim analysis the pre-specified stopping boundary for an overwhelming benefit had been crossed.)
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Agricola Eustachio, IRCCS San Raffaele

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.


Condition or disease Intervention/treatment Phase
Chronic Heart Failure Lung; Congestive Acute Decompensated Heart Failure Diagnostic Test: Lung ultrasound Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Usefulness of Lung Ultrasound in Ambulatory Management of Patients With Chronic Heart Failure
Actual Study Start Date : December 2010
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Group A includes patients undergoing lung ultrasound and physical examination.
Diagnostic Test: Lung ultrasound
Duretic therapy is then optimized according to the presence and severity of B-lines in group A.

Placebo Comparator: Group B
Group B includes patients undergoing physical examination only.
Diagnostic Test: Lung ultrasound
Duretic therapy is then optimized according to the presence and severity of B-lines in group A.




Primary Outcome Measures :
  1. Reduction of hospitalizations for acute decompensated heart failure [ Time Frame: 90 days ]
    Significant reduction of hospitalizations for acute decompensated heart failure in group A during the 90-day follow-up period.


Secondary Outcome Measures :
  1. Natriuretic peptides values [ Time Frame: 90 days ]
    Significant reduction of natriuretic peptides values in group A during the 90-day follow-up period.

  2. Quality of life test (QLT) score [ Time Frame: 90 days ]
    Significant reduction of QTL score in group A during the 90-day follow-up period.

  3. Cardiac mortality [ Time Frame: 90 days ]
    Significant reduction of cardiac mortality rate in group A versus group B.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262571


Locations
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Italy
San Raffaele Hospital
Milano, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele

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Responsible Party: Agricola Eustachio, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03262571    
Other Study ID Numbers: B-LINES
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Agricola Eustachio, IRCCS San Raffaele:
Heart failure
Lung ultrasound
B-lines
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases