Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    168
  • sponsor
    Puerta de Hierro University Hospital
Updated on 19 March 2021

Summary

The purpose of this study is to compare intravenous furosemide (125 to 250 mg), isolated or in combination with hypertonic saline solution (2.4% to 3.6%) 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.

Details
Condition Heart failure, Heart disease, Congestive Heart Failure, Cardiac Disease, cardiac failure, congestive heart disease
Treatment Intravenous Furosemide, Hypertonic saline solution plus intravenous furosemide
Clinical Study IdentifierNCT04533997
SponsorPuerta de Hierro University Hospital
Last Modified on19 March 2021

Eligibility

Yes No Not Sure

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
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 4 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
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