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Lung Ultrasoung Guided Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial (LUS-HF)

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: NCT02959372
Recruitment Status : Completed
First Posted : November 9, 2016
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description
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Brief Summary:

Introduction: Despite the great advances in treatment, heart failure (HF) continues to be an important health problem because of its high prevalence, morbidity, mortality and associated costs. Research shows at least 40% of HF in-patients are going to be readmitted in the following year. Thus, new strategies to reduce HF decompensations are needed.

In recent studies, pulmonary congestion which is expressed in the form of B-lines detected by lung ultrasound (LUS) has proven to be a potent prognostic predictor of hospitalization and mortality in HF. Moreover, the use of LUS is becoming more common due to its availability (with pocket devices with sizes approaching those of smart phones); its simplicity (rapid learning curve and rapid examination, less than 5 minutes) and its safety (radiation free).

We hypothesize that a management guided by LUS in HF patients may improve outcomes.

Objective: The aim of our study is to evaluate if ambulatory LUS guided treatment of patients after a hospitalization for HF, decreases the combined end-point of mortality or re-hospitalization after a 6 months follow-up.

Study design: The design of our study is a randomized, simple blinded, clinical trial.

Eligible patients are patients older than 18 years of age who have been hospitalized for HF. The exclusion criteria are life expectancy of less than 6 months or uninterpretable lung ultrasound. Eligible patients are going to be randomized into either the "LUS group" or the "control group".

The follow-up consists of visits to the HF clinic at periods of 15 days, 1, 3 and 6 months after the initial hospitalization. LUS is going to be performed on all patients despite their respective group. Only in relation to the "LUS group", the treating physician will have the result of the examination and the subsequent treatment adjustment could be made in response to those findings.

This study complies with the Declaration of Helsinki and the study protocol is being evaluated by the Ethic Committee of our institution.


Condition or disease Intervention/treatment Phase
Heart Failure Other: lung ultrasound Other: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Lung Ultrasoung Guided Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial
Study Start Date : November 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: lung ultrasound group
lung ultrasound results
 Other: lung ultrasound
Placebo Comparator: control group
The attending physician will not have the result of the lung ultrasound
 Other: placebo
lung ultrasound. The attending physician will not know the result


Outcome Measures
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Primary Outcome Measures :
  1. mortality or re-hospitalization [ Time Frame: 6 months follow-up ]

Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age over 18 years old
  • Current hospitalization for heart failure decompensation

Exclusion Criteria:

  • Not able to do the follow up
  • Life expectancy of less than 6 months
  • uninterpretable lung ultrasound
Contacts and Locations
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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): NCT02959372


Locations
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Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Study Director: Eulalia Roig Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
More Information
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02959372    
Other Study ID Numbers: IIBSP-ECO-2016-55
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases