Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

NCT04533997 | Completed Phase 3

• 1 other identifier: SALT-HF TRIAL
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Heart Failure

Keywords

Hypertonic Saline Solution; Outpatient Heart Failure

Outcome Measures

Primary Outcomes (1)

• Diuresis volume (ml)

  Total diuresis volume after 3 hours of therapy administration

  3 hours after treatment

Secondary Outcomes (11)

• Weight difference (kg)

  3 hours

• Weight difference (kg)

  7 days

• Change in composite congestion score

  7 days

• Change in Inferior cava vein diameter (mm)

  7 days

• Change in Number of fields with more than 3 B-lines in lung ultrasound

  7 days

Study Arms (2)

Intravenous furosemide

ACTIVE COMPARATOR

Drug: Intravenous furosemide

Hypertonic saline solution plus intravenous furosemide

EXPERIMENTAL

Drug: Hypertonic saline solution plus intravenous furosemide

Interventions

Hypertonic saline solution plus intravenous furosemide 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%

Hypertonic saline solution plus intravenous furosemide

Intravenous furosemide DRUG

Intravenous 60-minutes infusion of furosemide: 125 mg if home oral furosemide ≤ 160 mg, 250 mg if home oral furosemide \> 160 mg

Intravenous furosemide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead
• Instituto de Salud Carlos III: collaborator
• Spanish Society of Cardiology: collaborator

Study Sites (14)

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, 28933, Spain

Location

Hospital de la Santa Creu i Santa Pau (Fundación Privada Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, 10003, Spain

Location

Hospital Universitario Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clinico Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Doce de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Clínico Universitario Lozano de Blesa

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Marta Cobo Marcos, MD

  Hospital Universitario Puerta de Hierro. Madrid. Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Model Details: 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).

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: September 1, 2020
• Study Start: January 1, 2021
• Primary Completion: May 10, 2023
• Study Completion: September 30, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ES (14)