Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

M

Majadahonda Iron Gate University

Status and phase

Completed
Phase 3

Conditions

Heart Failure

Treatments

Drug: Hypertonic saline solution plus intravenous furosemide
Drug: Intravenous furosemide

Study type

Interventional

Funder types

Other

Identifiers

NCT04533997
SALT-HF TRIAL

Details and patient eligibility

About

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.

Full 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.

Enrollment

167 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

167 participants in 2 patient groups

Intravenous furosemide
Active Comparator group
Treatment:
Drug: Intravenous furosemide
Hypertonic saline solution plus intravenous furosemide
Experimental group
Treatment:
Drug: Hypertonic saline solution plus intravenous furosemide

Trial contacts and locations

14

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Central trial contact

Marta Cobo Marcos, MD

Data sourced from clinicaltrials.gov

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