DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics

Inclusion Criteria:

Subject is >18 and < 85 years of age.
Subject is hospitalized with primary diagnosis of ADHF.
N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,600 pg/m or BNP≥400 pg/mL.

Evidence of fluid overload as indicated by 2 or more of the following criteria:

peripheral edema ≥ 2+
radiographic pulmonary edema or pleural effusion
enlarged liver or ascites
pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
Jugular venous distention > 7 cmH2O
Subject insufficiently responds to IV diuretic therapy

Exclusion Criteria:

Systolic blood pressure <90 mmHg at the time of screening.
Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleural synthesis within past 7 days or cardiovascular intervention within past 4 days.
Known LVEF < 15% by echocardiography within 1 year prior to enrolment.
Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
Known active myocarditis, hypertrophic obstructive cardiomyopathy, constrictive pericarditis or cardiac tamponade.
Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis severe regurgitation) or Severe mitral disease with planned intervention.
Evidence of active systemic infection documented by either one of the following: fever >38°C/100°F, or ongoing uncontrolled infection (i.e., inflammatory parameters not decreasing despite > 48 hours of antibiotic treatment).
Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.