CLUSTER-HF: Lung Ultrasound Guided Therapy in Heart Failure
CLUSTER-HF: Lung Ultrasound Guided Therapy in Heart Failure
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.
Inclusion Criteria:

 -  Patients admitted to the hospital with the primary or secondary diagnosis of heart
 failure

 -  The intra-hospital stay extends for at least 24 hours.

 -  The patient shows new symptoms (or worsening of known symptoms) due to the
 presentation of heart failure, including at least one of the following: dyspnea
 (dyspnea at rest, at exertion, orthopnea, nocturnal paroxysmal dyspnea), decreased
 exercise capacity, fatigue or other symptoms of target organ hypoperfusion or volume
 overload.

 -  The patient has at least two physical examination findings; or at least one finding to
 the physical examination and at least one complementary criterion, including: physical
 examination findings that are considered to be due to heart failure (peripheral edema,
 increase in the abdominal perimeter or ascites in the absence of primary liver
 disease, signs of pulmonary congestion including crackles, subcrepitant rales or
 decrease in vesicular murmur, increase in jugular venous pressure and / or
 hepatojugular reflux, gallop by third sound (S3) or rapid weight gain, clinically
 significant, attributed to water retention); and/or complementary findings that are
 considered to be due to heart failure, including Increase in levels of
 N-terminal-pro-BNP (NT-proBNP) compatible with decompensation of heart failure (>
 2,000 pg / mL), radiographic evidence of pulmonary congestion, or invasive or
 non-invasive evidence of significant increase in ventricular filling pressures or
 decreased cardiac output.

 Exclusion Criteria:

 -  Non interpretable lung ultrasound imaging or false positive findings (chronic lung
 interstitial disease, pneumonia, large pleural effusion).

 -  Lack of willing to provide informed consent

 -  Life expectancy lesser than 6 months

 -  Surgically correctable cause of heart failure (aortic stenosis, mitral regurgitation,
 multi-vessel coronary artery disease).

 -  Chronic kidney injury with an estimated or measured creatinine clearance rate lower
 than 15ml/min/1.73m2.