Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Puerta de Hierro University Hospital
• Collaborators: Instituto de Salud Carlos III; Spanish Society of Cardiology
• Treatments: Furosemide

Criteria

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.