Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.
- Conditions
- Heart Failure
- Interventions
- Drug: Hypertonic saline solution plus intravenous furosemide
- Registration Number
- NCT04533997
- Lead Sponsor
- Puerta de Hierro University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 167
- Previous heart failure diagnosis (according to current European Guidelines)
- Stable treatment in the previous 4 weeks (except diuretic).
- Home oral treatment of ≥80 mg of furosemide/day or equivalent (40 mg furosemide = 20 mg of torasemide).
- Transthoracic echocardiogram performed in the last year.
- Congestive signs.The presence of two of the following congestion criteria will be required: jugular pressure> 10 cm, lower limb edema, ascites, or pleural effusion
- Elevation of natriuretic peptides (NTproBNP> 1000 pg / mL or B-type natriuretic peptide> 250 pg / ml) performed in a previous period of no more than 24 hours.
- Need for intravenous diuretic therapy to relieve congestion according to the responsible physician.
- Hospital admission criteria in the opinion of the responsible physician.
- Systolic blood pressure <90 mmHg or> 180 mmHg.
- Heart rate> 150 bpm or < 40 bpm
- Basal oxygen saturation less than 90%.
- Cardiogenic shock.
- Acute Pulmonary Edema.
- Clinically significant arrhythmia.
- Acute myocardial ischemia.
- Patients in hemodialysis or peritoneal dialysis program.
- Serum sodium <125 milliequivalent / L or> 145 milliequivalent / L.
- Serum potassium < 3.5 milliequivalent/ L.
- Hemoglobin < 9 g / dL
- Acute coronary syndrome or cardiological procedure in the previous 2 weeks.
- Severe uncorrected valve disease except tricuspid regurgitation.
- Moderate or severe dementia, active delirium or psychiatric problems.
- Patients in whom cardiac surgery or device implantation is planned in the following 30 days.
- Pregnancy or breastfeeding.
- Inability to give informed consent in the absence of a legal officer.
- Patients on tolvaptan.
- Inability to collect the urine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypertonic saline solution plus intravenous furosemide Hypertonic saline solution plus intravenous furosemide - Intravenous furosemide Intravenous furosemide -
- Primary Outcome Measures
Name Time Method Diuresis volume (ml) 3 hours after treatment Total diuresis volume after 3 hours of therapy administration
- Secondary Outcome Measures
Name Time Method Weight difference (kg) 7 days Difference of weight 7 days after the start of treatment
Change in composite congestion score 7 days Composite of orthopnoea (0-3), jugular venous distension (0-3), lower limb oedema (0-3). Higher score: worse congestion
Change in Inferior cava vein diameter (mm) 7 days Change in Inferior cava vein diameter (mm) 7 days after treatment
Change in Number of fields with more than 3 B-lines in lung ultrasound 7 days Change in Number of fields with more than 3 B-lines in lung ultrasound 7 days after treatment
Change in New York Heart Association and Visual Analogue Scale 7 days Visual Analogue Scale from 0 (worst state of health) to 100 (best state of health)
Change in NTproBNP and Cancer Antigen 125 levels 7 days Change in NTproBNP and Cancer Antigen 125 levels 7 days after treatment
Change in Hemoconcentration Parameters 7 days Hematocrit, Albumin and total Proteins
Change in Urinary Sodium 7 days Change in Urinary Sodium measured in a spot urinary sample
Adverse Events 30 days Need of new intravenous diuretic (outpatient clinic or emergency department). Heart Failure hospitalization. Cardiovascular mortality. All-Cause mortality or hospitalization.
Trial Locations
- Locations (14)
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital Universitario Rey Juan Carlos
🇪🇸Móstoles, Madrid, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital de la Santa Creu i Santa Pau (Fundación Privada Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Hospital Universitario Arnau de Vilanova
🇪🇸Lérida, Spain
Hospital San Pedro de Alcántara
🇪🇸Cáceres, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clinico Universitario San Carlos
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitario Doce de Octubre
🇪🇸Madrid, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Clínico Universitario Lozano de Blesa
🇪🇸Zaragoza, Spain