Heart FailurePhase 3NCT04533997
Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.
A Phase 3 study testing Hypertonic saline solution plus intravenous furosemide and Intravenous furosemide in people with Heart Failure, run by Puerta de Hierro University Hospital at 14 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Hypertonic saline solution plus intravenous furosemide and Intravenous furosemide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 14 sitesSpain
- Study dates
- 1 Jan 2021to 30 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Hospital de la Santa Creu i Santa Pau (Fundación Privada Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital San Pedro de Alcántara
Cáceres, 10003
Hospital Universitario Arnau de Vilanova
Lleida, 25198
Hospital Universitario La Princesa
Madrid, 28006
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Clinico Universitario San Carlos
Madrid, 28040
Hospital Universitario Doce de Octubre
Madrid, 28041
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933
Hospital Clinico Universitario de Valencia
Valencia, 46010
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Clínico Universitario Lozano de Blesa
Zaragoza, 50009
About this study
Official title: Efficacy and Safety of Ambulatory Hypertonic Saline Therapy in Outpatient Heart Failure Units.
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.
Read the detailed 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.
- Conditions
- Heart Failure
- Being tested
- Hypertonic saline solution plus intravenous furosemide, Intravenous furosemide
- Keywords
- Hypertonic Saline Solution, Outpatient Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic saline solution plus intravenous furosemideDrug
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%
Intravenous furosemideDrug
Intravenous 60-minutes infusion of furosemide:
125 mg if home oral furosemide ≤ 160 mg, 250 mg if home oral furosemide > 160 mg
| Study group | Role | What they receive |
|---|---|---|
| Intravenous furosemide | Active comparator | Not described Receives: Drug: Intravenous furosemide |
| Hypertonic saline solution plus intravenous furosemide | Experimental | Not described Receives: Drug: Hypertonic saline solution plus intravenous furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diuresis volume (ml)
Total diuresis volume after 3 hours of therapy administration
Measured: 3 hours after treatment
Secondary outcomes (11)
Weight difference (kg)
Difference of weight 3 hours after the start of treatment
Measured: 3 hours
Weight difference (kg)
Difference of weight 7 days after the start of treatment
Measured: 7 days
Change in composite congestion score
Composite of orthopnoea (0-3), jugular venous distension (0-3), lower limb oedema (0-3). Higher score: worse congestion
Measured: 7 days
Change in Inferior cava vein diameter (mm)
Change in Inferior cava vein diameter (mm) 7 days after treatment
Measured: 7 days
Change in Number of fields with more than 3 B-lines in lung ultrasound
Change in Number of fields with more than 3 B-lines in lung ultrasound 7 days after treatment
Measured: 7 days
Change in New York Heart Association and Visual Analogue Scale
Visual Analogue Scale from 0 (worst state of health) to 100 (best state of health)
Measured: 7 days
Change in NTproBNP and Cancer Antigen 125 levels
Change in NTproBNP and Cancer Antigen 125 levels 7 days after treatment
Measured: 7 days
Change in Hemoconcentration Parameters
Hematocrit, Albumin and total Proteins
Measured: 7 days
Change in Urinary Sodium
Change in Urinary Sodium measured in a spot urinary sample
Measured: 7 days
Adverse Events
Need of new intravenous diuretic (outpatient clinic or emergency department). Heart Failure hospitalization. Cardiovascular mortality. All-Cause mortality or hospitalization. Worsening of kidney function: defined as an increase in creatinine ≥ 0.3 mg / dl.
Electrolyte abnormalities defined as hypokalemia (K+ less than 3.5 milliequivalent / L) or hyperkalemia (K+ greater than 5.5 milliequivalent /L)
Measured: 7 days
Adverse Events
Need of new intravenous diuretic (outpatient clinic or emergency department). Heart Failure hospitalization. Cardiovascular mortality. All-Cause mortality or hospitalization.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Jan 2021
- Primary completion10 May 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Spanish Society of Cardiology
- Responsible party
- Principal investigator, Marta Cobo Marcos, Puerta de Hierro University Hospital
- Investigators
- Marta Cobo Marcos, MD, Principal investigator, Hospital Universitario Puerta de Hierro. Madrid. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533997
- Sponsor's protocol ID
- SALT-HF TRIAL
- Status last verified
- Nov 2023
- First submitted
- 23 Aug 2020
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ambulatory Hypertonic Saline Therapy in Outpatient Heart Failure Units.
- ClinicalTrials.gov ID
- NCT04533997
- Acronym / sponsor ID
- SALT-HF TRIAL
- Conditions
- Heart Failure
- Keywords
- Hypertonic Saline Solution, Outpatient Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Spanish Society of Cardiology
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intravenous furosemide | Active comparator | Drug: Intravenous furosemide |
| Hypertonic saline solution plus intravenous furosemide | Experimental | Drug: Hypertonic saline solution plus intravenous furosemide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic saline solution plus intravenous furosemideIntravenous 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% | Drug | Hypertonic saline solution plus intravenous furosemide |
| Intravenous furosemideIntravenous 60-minutes infusion of furosemide: 125 mg if home oral furosemide ≤ 160 mg, 250 mg if home oral furosemide > 160 mg | Drug | Intravenous furosemide |
Primary outcome
Diuresis volume (ml)
Time frame: 3 hours after treatment
Total diuresis volume after 3 hours of therapy administration
11 secondary outcomes
Weight difference (kg)
Time frame: 3 hours
Weight difference (kg)
Time frame: 7 days
Change in composite congestion score
Time frame: 7 days
Change in Inferior cava vein diameter (mm)
Time frame: 7 days
Change in Number of fields with more than 3 B-lines in lung ultrasound
Time frame: 7 days
Change in New York Heart Association and Visual Analogue Scale
Time frame: 7 days
Change in NTproBNP and Cancer Antigen 125 levels
Time frame: 7 days
Change in Hemoconcentration Parameters
Time frame: 7 days
Change in Urinary Sodium
Time frame: 7 days
Adverse Events
Time frame: 7 days
Adverse Events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Cobo Marcos, MD principal investigator
Hospital Universitario Puerta de Hierro. Madrid. Spain
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypertonic saline solution plus intravenous furosemide and Intravenous furosemide in people with Heart Failure, run by Puerta de Hierro University Hospital at 14 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diuresis volume (ml) (time frame: 3 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.