Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Based on an automated online system, blinded to the physicians who evaluated the patient.

Randomization was performed by a trained nurse in a separate room

Study Groups

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Intravenous furosemide

Group Type ACTIVE_COMPARATOR

Intravenous furosemide

Intervention Type DRUG

Intravenous 60-minutes infusion of furosemide:

125 mg if home oral furosemide ≤ 160 mg, 250 mg if home oral furosemide \> 160 mg

Hypertonic saline solution plus intravenous furosemide

Group Type EXPERIMENTAL

Hypertonic saline solution plus intravenous furosemide

Intervention Type DRUG

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%

Interventions

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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%

Intervention Type DRUG

Intravenous furosemide

Intravenous 60-minutes infusion of furosemide:

125 mg if home oral furosemide ≤ 160 mg, 250 mg if home oral furosemide \> 160 mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No