Heart FailureLUSA-HFNCT04226755
Liberal Use of Sodium in Ambulatory Heart Failure
A study testing Sodium chloride in people with Heart Failure, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
This study investigates the effects of an increased sodium intake in heart failure patients with reduced ejection fraction and age-matched volunteers without heart failure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sodium chloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2020to 30 Jun 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Heart failure patients:
- Left ventricular ejection fraction ≤40% on echocardiogram obtained at inclusion
- Stable dose of guideline-recommended disease modifying drugs for at least 3 months.
- Maximum daily loop diuretic dose of 40 mg furosemide equivalents with a stable dose for the last month
- Healthy volunteers:
- Age > 60 y
Show all 9Show fewer
- Normal ejection fraction (>50%) without heart failure
- No neurohormonal blockers for hypertension
- Normal NT-proBNP
Who cannot join
- Heart failure hospitalization for congestion or myocardial infarction in past 3 months
- Permanent atrial fibrillation
- New York Heart Association (NYHA) class III-IV
- Estimated glomerular filtration rate (eGFR) < 30 mL/min
- Signs of congestion
- Severe right ventricular dysfunction
Show all 9Show fewer
- Severe valvular disease
- Cardiothoracic anatomy not allowing satisfactory and reproducible recordings of echocardiogram
- Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the effects of an increased sodium intake in heart failure patients with reduced ejection fraction and age-matched volunteers without heart failure.
Read the detailed description
At the start of the study, baseline investigations are performed including assessment of vital signs (blood pressure, heart rate, pulse oxygen saturation), weight, Everest congestion score (consisting of grading of dyspnea, orthopnea, jugular venous distention, rales, edema and fatigue), echocardiography, 24h urine collection, bio-impedance measurements and blood sample analysis with plasma renin and aldosterone Subsequently, a run-in phase of 2 weeks, without intervention, will start. After this run-in period, participants will be reassessed with the same baseline investigations. In addition, a skin biopsy will be performed as well as a blood volume measurement.
In the next phase of the study, salt intake will be increased with 3 grams daily. The salt will be packed in capsules containing 1 g of sodium chloride (NaCl). Patients will be asked to take one capsule with their breakfast, lunch and dinner. Every 2 weeks a follow-up visit is planned.
After 4 weeks of increased salt intake, a new skin biopsy will be taken and a blood volume measurement will be performed.
- Conditions
- Heart Failure
- Being tested
- Sodium chloride
- Keywords
- Sodium, Salt, 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.
Sodium chlorideDietary supplement
1 gram tid (with every meal)
| Study group | Role | What they receive |
|---|---|---|
| Heart failure | Experimental | After a run-in phase of 2 weeks, patients will add 3 g of sodium chloride to every meal, using a NaCl tablet of 1 g. They will continue the sodium tablet for 4 weeks with a study visit every 2 weeks. A skin biopsy will be performed before the start of the augmented salt intake and after 4 weeks. Receives: Dietary Supplement: Sodium chloride |
| Healthy volunteer | Active comparator | After a run-in phase of 2 weeks, volunteers will add 3 g of sodium chloride to every meal, using a NaCl tablet of 1 g. They will continue the sodium tablet for 4 weeks with a study visit every 2 weeks.A skin biopsy will be performed before the start of the augmented salt intake and after 4 weeks. Receives: Dietary Supplement: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in skin glycosaminoglycan (GAG) content
Measured: 4 weeks
Changes in skin sodium content
Measured: 4 weeks
Secondary outcomes (5)
Changes in blood volume assessed by radiolabeled red blood cell technique
Measured: 4 weeks
Changes in extracellular, intravascular volume and total body fluid volume (assessed with bioimpedance)
Measured: 6 weeks
Changes in renal sodium handling
Measured: 6 weeks
Changes in cardiac geometry assessed by echo
Measured: 6 weeks
Changes in renal venous flow pattern
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jun 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilfried Mullens, Ziekenhuis Oost-Limburg
- Investigators
- Jeroen Dauw, MD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226755
- Sponsor's protocol ID
- ZOLCAR19001
- Acronym
- LUSA-HF
- Status last verified
- Jun 2023
- First submitted
- 9 Jan 2020
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberal Use of Sodium in Ambulatory Heart Failure
- ClinicalTrials.gov ID
- NCT04226755
- Acronym / sponsor ID
- LUSA-HF / ZOLCAR19001
- Conditions
- Heart Failure
- Keywords
- Sodium, Salt, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 13 Jan 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.
This study investigates the effects of an increased sodium intake in heart failure patients with reduced ejection fraction and age-matched volunteers without heart failure.
Detailed description
At the start of the study, baseline investigations are performed including assessment of vital signs (blood pressure, heart rate, pulse oxygen saturation), weight, Everest congestion score (consisting of grading of dyspnea, orthopnea, jugular venous distention, rales, edema and fatigue), echocardiography, 24h urine collection, bio-impedance measurements and blood sample analysis with plasma renin and aldosterone Subsequently, a run-in phase of 2 weeks, without intervention, will start. After this run-in period, participants will be reassessed with the same baseline investigations. In addition, a skin biopsy will be performed as well as a blood volume measurement.
In the next phase of the study, salt intake will be increased with 3 grams daily. The salt will be packed in capsules containing 1 g of sodium chloride (NaCl). Patients will be asked to take one capsule with their breakfast, lunch and dinner. Every 2 weeks a follow-up visit is planned.
After 4 weeks of increased salt intake, a new skin biopsy will be taken and a blood volume measurement will be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart failure | Experimental | Dietary Supplement: Sodium chlorideAfter a run-in phase of 2 weeks, patients will add 3 g of sodium chloride to every meal, using a NaCl tablet of 1 g. They will continue the sodium tablet for 4 weeks with a study visit every 2 weeks. A skin biopsy will be performed before the start of the augmented salt intake and after 4 weeks. |
| Healthy volunteer | Active comparator | Dietary Supplement: Sodium chlorideAfter a run-in phase of 2 weeks, volunteers will add 3 g of sodium chloride to every meal, using a NaCl tablet of 1 g. They will continue the sodium tablet for 4 weeks with a study visit every 2 weeks.A skin biopsy will be performed before the start of the augmented salt intake and after 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Heart failure patients:
- Healthy volunteers:
Key exclusion criteria (9 listed)
- Heart failure hospitalization for congestion or myocardial infarction in past 3 months
- Permanent atrial fibrillation
- New York Heart Association (NYHA) class III-IV
- Estimated glomerular filtration rate (eGFR) < 30 mL/min
- Signs of congestion
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 |
|---|---|---|
| Sodium chloride1 gram tid (with every meal) | Dietary supplement | Healthy volunteer, Heart failure |
Primary outcome
Changes in skin glycosaminoglycan (GAG) content
Time frame: 4 weeks
Changes in skin sodium content
Time frame: 4 weeks
5 secondary outcomes
Changes in blood volume assessed by radiolabeled red blood cell technique
Time frame: 4 weeks
Changes in extracellular, intravascular volume and total body fluid volume (assessed with bioimpedance)
Time frame: 6 weeks
Changes in renal sodium handling
Time frame: 6 weeks
Changes in cardiac geometry assessed by echo
Time frame: 6 weeks
Changes in renal venous flow pattern
Time frame: 6 weeks
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 22 Jun 2023.
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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.
Jeroen Dauw, MD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium chloride in people with Heart Failure, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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 9 inclusion and 9 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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.
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?
Changes in skin glycosaminoglycan (GAG) content (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 22 Jun 2023.