Worsening renal function (WRF) is a frequent finding in patients with decompensated acute heart failure (AHF) and it is associated to increased length of hospitalization and higher morbidity and mortality. Traditionally, WRF in AHF setting has been attributed to low cardiac output, but recent evidence also suggests venous congestion play a crucial role. Loop diuretics are the mainstay treatment of AHF, but their use traditionally has been associated to WRF, but also renal function improvement in patients with unequivocal signs of congestion. Nevertheless, traditional symptoms or signs of patients with AHF have shown a limited accuracy to neither identify nor quantify the degree of venous congestion. Recent authors have reported that plasma levels of antigen carbohydrate 125 (CA125) are closely related to the degree of venous congestion. The investigators hypothesize that CA125 may have a role for identifying the hyperhydrated (High CA125) patients that need high loop diuretic doses, and those with normal CA125 values needing low loop diuretic doses. In this randomized study (1:1) the investigators seek to evaluate whether a CA125 loop diuretic guided management therapy is superior to a standard strategy. The primary endpoint is the magnitude of changes of renal function at 24 and 72 hours after initiation of intravenous diuretic in an acute worsening of heart failure
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
170
Initial dose of intravenous furosemide ≤80 mg / day regardless of prior dose of loop diuretics who were receiving.
Initial dose of intravenous furosemide ≥120 mg/day or 2.5 times the dose the patient was taking at home.
The dosage of loop diuretics is done according to the presence of symptoms and signs of systemic congestion and current recommendations
Hospital Clínico Universitario de Valencia
Valencia, Spain
Change in renal function (GFR)
Glomerular filtration rate (GFR) estimated by MDRD. Prespecified interim analysis of primary outcome will be made by protocol when first 100 patients are included.
Time frame: 24 and 72 hours
Improvement in signs and symptoms of heart failure (NYHA)
Evaluation of dyspnea (changes in the functional class of the New York Heart Association -NYHA)
Time frame: 24 and 72 hours
Improvement in signs and symptoms of heart failure (VAS)
Evaluation of signs of systemic congestion, and patient global assessment (by visual analogue scale -VAS-)
Time frame: 24 and 72 hours
Changes in plasma levels of natriuretic peptide (NT-proBNP)
Time frame: 72 hours
Changes in plasma levels of high sensitive troponin
Time frame: 72 hours
Time required to change intravenous diuretics to oral administration.
Time frame: Through study completion (30-day follow-up)
Composite of all-cause mortality plus acute heart failure related rehospitalization
Number of events in each group during 30-day follow-up
Time frame: 30 days
Change in renal function (creatinin)
Serum levels of creatinine
Time frame: 24 h, 72 h and 30 days
Change in renal function (urea)
Serum levels of urea
Time frame: 24 h, 72 h and 30 days
Change in renal function (cystatin C)
Serum levels of Cystatin C
Time frame: 24 h, 72 h and 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.