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

February 24, 2019 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Hospital De La Santa Creu I Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality or re-hospitalization
Time Frame: 6 months follow-up
6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

  • Study Director: Eulalia Roig, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 9, 2016

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 24, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-ECO-2016-55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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