The present is a multicenter, prospective, randomized, open-label, blinded end-point trial aiming to investigate the clinical benefit of a stepwise, natriuresis-driven diuretic strategy versus standard diuretic treatment in patients with acute decompensated heart failure with reduced ejection fraction (HFrEF) and low early urinary sodium excretion. The study will focus on patients at increased risk of resistance to diuretic therapy. In particular, patients admitted to the emergency department and cardiac intensive care unit due to an on-chronic or de-novo acute decompensated HF episode with a predominantly "wet" profile and low early spot urinary sodium (UNa+) excretion will be considered. Spot natriuresis is a low-cost, non-demanding laboratory test in use to identify diuretic-resistant patients with an inherent poor prognosis. Whether the early identification of diuretic resistant patients and the consequent more aggressive treatment may lead to a better outcome has not been demonstrated by randomized studies. This trial aims to assess if an intensive stepwise diuretic approach guided by systematic urinary output assessment including natriuresis evaluation versus a standard diuretic strategy based on urinary output alone effectively leads to faster euvolemia achievement and better prognosis in a real-world setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
198
Intensive stepwise diuretic treatment based on combined diuresis and urinary sodium assessment
Stepwise diuretic therapy based on diuresis assessment
A.O.U. Città della Salute e della Scienza di Torino
Torino, To, Italy
Evidence of significant reduction of congestion defined as absolute reduction of at least 1 point in wet score grading of congestion after 48 hours of treatment
Assessment of WET score (Gheorghiade et al, EJHF 2010)
Time frame: 48 hours
Treatment failure, defined as persistent congestion (graded by wet score ≥12/20) after 24, 48 and 72 hours of diuretic treatment or need for renal replacement therapy.
Time frame: 24,48 and 72 hours
Freedom from congestion at 48 hours, defined as jugular venous pressure of <8 cm, with no orthopnea and with trace peripheral edema or no edema
Time frame: 48 hours
Worsening or persistent heart failure
worsening heart failure symptoms or failure of the patient's condition to improve with treatment requiring the initiation of intravenous inotropic therapy and/or the implementation of mechanical circulatory or ventilatory support up until 48 hours
Time frame: 48 hours
Composite endpoint of all-cause mortality, urgent LVAD implant or Heart Transplantation at 30 and 90 days.
Time frame: 30 and 90 days
All-cause mortality
Time frame: 30 and 90 days
Cardiac cause mortality
including myocardial infarction, irreversible heart failure, cardiogenic shock, fatal arrhythmic events
Time frame: 30 and 90 days
Rehospitalization for heart failure
Time frame: 30 and 90 days
Worsening renal function
absolute increase in serum creatinine \> 0.3 mg/dl or \> 1,5-fold from baseline at any time from randomization to 48 hours
Time frame: 48 hours
Incidence of severe hypokalemia, severe hyponatremia or symptomatic electrolytes disorders during treatment protocol
hypokalemia \<3 mEq/L, severe hyponatremia \<125 mEq/L
Time frame: 72 hours
Severe symptomatic hypotension
Systolic arterial pressure \< 80 mmHg
Time frame: 72 hours
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