Clinical trial NCT04533997: Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.
Official title: Efficacy and Safety of Ambulatory Hypertonic Saline Therapy in Outpatient Heart Failure Units.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Keywords: Hypertonic Saline Solution
Outpatient Heart Failure
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Spanish Society of Cardiology
First posted: 2020-09-01
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization 1:1 to treatment with a 1-hour infusion of IV furosemide plus HSS (2.6-3.4% NaCl depending on plasmatic sodium levels) versus a 1-hour infusion of IV furosemide at the same dose (125-250 mg, depending on basal loop diuretic dose).
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Diuresis volume (ml)
timeFrame: 3 hours after treatment
Secondary outcomes:
measure: Weight difference (kg)
timeFrame: 3 hours
measure: Weight difference (kg)
timeFrame: 7 days
measure: Change in composite congestion score
timeFrame: 7 days
measure: Change in Inferior cava vein diameter (mm)
timeFrame: 7 days
measure: Change in Number of fields with more than 3 B-lines in lung ultrasound
timeFrame: 7 days
measure: Change in New York Heart Association and Visual Analogue Scale
timeFrame: 7 days
measure: Change in NTproBNP and Cancer Antigen 125 levels
timeFrame: 7 days
measure: Change in Hemoconcentration Parameters
timeFrame: 7 days
measure: Change in Urinary Sodium
timeFrame: 7 days
measure: Adverse Events
timeFrame: 7 days
measure: Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario Rey Juan Carlos
state: Madrid
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Santa Pau (Fundación Privada Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Lérida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Doce de Octubre
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano de Blesa
Study officials:
affiliation: Hospital Universitario Puerta de Hierro. Madrid. Spain
name: Marta Cobo Marcos, MD
role: PRINCIPAL_INVESTIGATOR
References: