Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Heart Failure

Clinical Trial Details

NCT number	NCT04533997
Study type	Interventional
Source	Puerta de Hierro University Hospital
Contact
Status	Completed
Phase	Phase 3
Start date	January 1, 2021
Completion date	September 30, 2023

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