Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

Heart Failure Clinical Trial

Official title:

Efficacy and Safety of Ambulatory Hypertonic Saline Therapy in Outpatient Heart Failure Units.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533997
• Other study ID #: SALT-HF TRIAL
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: September 30, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Hypertonic saline solution plus intravenous furosemide
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 furosemide
Intravenous 60-minutes infusion of furosemide: 125 mg if home oral furosemide = 160 mg, 250 mg if home oral furosemide > 160 mg

Locations

Country	Name	City	State
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 San Pedro de Alcántara	Cáceres
Spain	Hospital Universitario Arnau de Vilanova	Lérida
Spain	Hospital Clinico Universitario San Carlos	Madrid
Spain	Hospital Universitario Doce de Octubre	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Universitario Rey Juan Carlos	Móstoles	Madrid
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital Clínico Universitario Lozano de Blesa	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital	Instituto de Salud Carlos III, Spanish Society of Cardiology

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diuresis volume (ml)	Total diuresis volume after 3 hours of therapy administration	3 hours after treatment
Secondary	Weight difference (kg)	Difference of weight 3 hours after the start of treatment	3 hours
Secondary	Weight difference (kg)	Difference of weight 7 days after the start of treatment	7 days
Secondary	Change in composite congestion score	Composite of orthopnoea (0-3), jugular venous distension (0-3), lower limb oedema (0-3). Higher score: worse congestion	7 days
Secondary	Change in Inferior cava vein diameter (mm)	Change in Inferior cava vein diameter (mm) 7 days after treatment	7 days
Secondary	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	7 days
Secondary	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)	7 days
Secondary	Change in NTproBNP and Cancer Antigen 125 levels	Change in NTproBNP and Cancer Antigen 125 levels 7 days after treatment	7 days
Secondary	Change in Hemoconcentration Parameters	Hematocrit, Albumin and total Proteins	7 days
Secondary	Change in Urinary Sodium	Change in Urinary Sodium measured in a spot urinary sample	7 days
Secondary	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)	7 days
Secondary	Adverse Events	Need of new intravenous diuretic (outpatient clinic or emergency department). Heart Failure hospitalization. Cardiovascular mortality. All-Cause mortality or hospitalization.	30 days