BioImpedentiometry, Lung UltraSound and cONgestion in Heart Failure (BLUEMOON)
Congestive Heart Failure
About this trial
This is an interventional diagnostic trial for Congestive Heart Failure focused on measuring congestion, total body water, bioimpedentiometry, lung ultrasound, diuretics, dyspnea, pulmonary B lines, deuterium
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent
Group-specific inclusion criteria:
Group 1 (Acute Heart Failure - AHF), patient admitted to the hospital for acute heart failure (de-novo or exacerbation of chronic heart failure), who have at least two of the following congestion criteria:
- weight gain ≥ 2 kg over the three days prior to hospitalization
- physical findings or radiographic signs of pulmonary congestion (crackles, semi-orthopnea)
- Hepatomegaly > 2 cm from the arch rib or ascites
- jugular turgor or central venous pressure > 10 cm H20
- Ankle swelling
Group 2 (Chronic Heart Failure - CHF): outpatients with chronic heart failure (CHF) with characters of clinical stability
- No hospitalization in the previous six months
- Symptoms stable for at least 4 weeks
- Oral therapy stable for at least 4 weeks
- No involuntary weight variations greater than 2 kg in the last 4 weeks
- Absence of signs of congestion
Group 3 (advanced Chronic Heart Failure - ad-CHF) Patients on optimal medical therapy for HF and treated with periodic infusions of levosimendan (every 4 weeks) according to the following criteria
- Systolic dysfunction (LVEF <35%)
- NYHA Class IIIb-IV and/or level INTERMACS 4, 5, 6
- ≥2 admissions or access to the emergency department for acute HF exacerbation in the previous 12 months
Exclusion Criteria:
- Uremia in dialysis treatment
- Invasive mechanical ventilation
- Mechanical circulatory support
- Cardiac cachexia defined as weight loss ≥ 5% in the prior 12 months or body mass index <20 kg/m2 and hypoalbuminemia (albumin <3.2 g/dl) or anemia (hemoglobin <12 g/l)
Sites / Locations
- Institute of Clinical Physiology National Research Council
Arms of the Study
Arm 1
Other
Acute heart failure HF,Chronic HF,Advanced chronic HF
patient admitted to the hospital for acute heart failure (de-novo or exacerbation of chronic heart failure), for Chronic HF and for Advanced chronic heart failure