Lung Ultrasoung Guided Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial (LUS-HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
lung ultrasound
placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure
Eligibility 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
Sites / Locations
- Hospital de la Santa Creu i Sant Pau
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
lung ultrasound group
control group
Arm Description
lung ultrasound results
The attending physician will not have the result of the lung ultrasound
Outcomes
Primary Outcome Measures
mortality or re-hospitalization
Secondary Outcome Measures
Full Information
NCT ID
NCT02959372
First Posted
November 7, 2016
Last Updated
February 24, 2019
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT02959372
Brief Title
Lung Ultrasoung Guided Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial
Acronym
LUS-HF
Official Title
Lung Ultrasoung Guided Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lung ultrasound group
Arm Type
Experimental
Arm Description
lung ultrasound results
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
The attending physician will not have the result of the lung ultrasound
Intervention Type
Other
Intervention Name(s)
lung ultrasound
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
lung ultrasound. The attending physician will not know the result
Primary Outcome Measure Information:
Title
mortality or re-hospitalization
Time Frame
6 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eulalia Roig
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Lung Ultrasoung Guided Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial
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