The purpose of this study is to compare intravenous furosemide (125 to 250 mg), isolated or in combination with hypertonic saline solution (2.6% to 3.4%) in the outpatient heart failure patient. The hypothesis is that the combination therapy will increase the diuresis volume at 3 hours and improve congestion parameters at 7 days.
This is a randomized, double-blind, multicenter study of all consecutive patients with decompensated heart failure and signs of volume overload who do not require hospital admission but require intravenous diuretic for relief of congestion. Patients meeting the inclusion criteria, with prior informed consent, will be randomized to treatment with furosemide with hypertonic saline versus isolated furosemide (control group). Complete clinical evaluation, echocardiography, and blood and urinary tests will be performed before the treatment. After 3 hours, diuresis volume, weight and urinary parameters will be evaluated. Efficacy and safety visits will be performed at 7 and 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
167
Intravenous 60-minutes of hypertonic saline therapy plus furosemide: Furosemide: 125 mg if home oral furosemide ≤160 mg, 250 mg if home oral furosemide \> 160 mg Hypertonic saline solution: Na+ 125-134: 3.4%, Na+ 135-145: 2.6%
Intravenous 60-minutes infusion of furosemide: 125 mg if home oral furosemide ≤ 160 mg, 250 mg if home oral furosemide \> 160 mg
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, Spain
Hospital de la Santa Creu i Santa Pau (Fundación Privada Hospital de la Santa Creu i Sant Pau
Diuresis volume (ml)
Total diuresis volume after 3 hours of therapy administration
Time frame: 3 hours after treatment
Weight difference (kg)
Difference of weight 3 hours after the start of treatment
Time frame: 3 hours
Weight difference (kg)
Difference of weight 7 days after the start of treatment
Time frame: 7 days
Change in composite congestion score
Composite of orthopnoea (0-3), jugular venous distension (0-3), lower limb oedema (0-3). Higher score: worse congestion
Time frame: 7 days
Change in Inferior cava vein diameter (mm)
Change in Inferior cava vein diameter (mm) 7 days after treatment
Time frame: 7 days
Change in Number of fields with more than 3 B-lines in lung ultrasound
Change in Number of fields with more than 3 B-lines in lung ultrasound 7 days after treatment
Time frame: 7 days
Change in New York Heart Association and Visual Analogue Scale
Visual Analogue Scale from 0 (worst state of health) to 100 (best state of health)
Time frame: 7 days
Change in NTproBNP and Cancer Antigen 125 levels
Change in NTproBNP and Cancer Antigen 125 levels 7 days after treatment
Time frame: 7 days
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Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital Universitario Arnau de Vilanova
Lleida, Spain
Hospital Universitario La Princesa
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Clinico Universitario San Carlos
Madrid, Spain
Hospital Universitario Doce de Octubre
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...and 4 more locations
Change in Hemoconcentration Parameters
Hematocrit, Albumin and total Proteins
Time frame: 7 days
Change in Urinary Sodium
Change in Urinary Sodium measured in a spot urinary sample
Time frame: 7 days
Adverse Events
Need of new intravenous diuretic (outpatient clinic or emergency department). Heart Failure hospitalization. Cardiovascular mortality. All-Cause mortality or hospitalization. Worsening of kidney function: defined as an increase in creatinine ≥ 0.3 mg / dl. Electrolyte abnormalities defined as hypokalemia (K+ less than 3.5 milliequivalent / L) or hyperkalemia (K+ greater than 5.5 milliequivalent /L)
Time frame: 7 days
Adverse Events
Need of new intravenous diuretic (outpatient clinic or emergency department). Heart Failure hospitalization. Cardiovascular mortality. All-Cause mortality or hospitalization.
Time frame: 30 days