CLUSTER-HF: Lung Ultrasound Guided Therapy in Heart Failure (CLUSTER-HF)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Lung ultrasound, Heart failure, Management
Eligibility Criteria
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.
Sites / Locations
- Instituto Nacional de Cardiología "Ignacio Chavez"
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
LUS-guided therapy group
Control group.
LUS-guided therapy group. Patients randomly allocated to this arm will receive standard of care + LUS examination accessible to treating physician in every visit. Depending on the results of LUS examination, a low dose or high dose of diuretics will be administered. A standardized algorithm will be provided to ensure compliance to guideline-recommended medical therapy for heart failure.
Control group. Patients randomly allocated to this arm will receive standard of care + LUS examination blinded to the treating physician in every visit. Diuretic titration will be based on standard practice (physical examination, symptoms and lab results). A standardized algorithm will be provided to ensure compliance to guideline-recommended medical therapy for heart failure.