Heart Failure Clinical Trial
Official title:
Efficacy of Lung Ultrasound Guided Therapy to Prevent Rehospitalizations in Heart Failure (CLUSTER-HF): a Randomized Controlled Trial
Introduction: Heart failure is the leading cause of hospitalization among adults >65 years of
age. Discharge from a heart failure hospitalization is followed by a 30 day readmission rate
of ≈24%. Readmissions for heart failure are typically preceded by a gradual rise in
ventricular filling pressures that begins days or weeks before any detectable changes in
clinical status.
Lung ultrasound (LUS) is a tool that is easily available at bedside and shows superior
sensitivity for the detection of pulmonary congestion when compared with X ray or physical
examination, even in the absence of symptoms.
Pulmonary congestion assessed by LUS identifies a subgroup with worse prognosis and a higher
rate of readmission and mortality. Whether the implementation of lung ultrasound in the
follow up of heart failure patients may reduce the rate of readmissions is unknown.
Objective: The aim of this study is to evaluate a protocol of lung ultrasound guided therapy
to prevent readmissions in heart failure outpatients.
Study design: the design of the investigator's study is a single center, single blinded,
randomized controlled clinical trial.
Eligibility criteria: patients older than 18 years of age, who have been hospitalized for an
acute heart failure syndrome. Exclusion criteria are life expectancy of less than 6 months, a
surgically correctable cause of heart failure or uninterpretable lung ultrasound.
Eligible patients will be randomized into either "LUS-guided therapy group" or "control
group" at hospital discharge. Follow-up visits will be scheduled at 15 days, 45 days, 3
months and 6 months after hospital discharge. LUS will be performed in all patients at
hospital discharge and in every follow-up visit, but only in those allocated to the
"LUS-guided therapy group" the information will be provided to the treating physician.
In the "LUS-guided therapy group", a prespecified diuretic dose will be administered to
patients depending on the degree of ultrasonographic pulmonary congestion: if congestive (3
or more B lines, in total) a high dose (80-120mg furosemide PO/day) will be prescribed; if no
congestive (less than 3 B lines, in total) a low dose (up to 40mg PO/day) will be prescribed.
Primary outcome will be the composite of hospital readmission + mortality. This study
complies with the Declaration of Helsinki and the study protocol is being evaluated by the
Ethic Committee of our institution.
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