Chronic Heart Failure With Reduced Ejection FractionRESALT-CHFNCT07614295
Effects of Repletion of Sodium Chloride on Natriuresis, Blood Pressure, and Neurohormonal Activity in Patients With Chronic Heart Failure With Reduced Ejection Fraction
A study testing Sodium chloride supplementation in people with Chronic Heart Failure With Reduced Ejection Fraction, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
The study is a single-center, prospective, randomized, placebo-controlled, double-blind trial conducted at the Institute of Heart Diseases and the Department of Cardiology of Wroclaw Medical University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Sodium chloride supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- May 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Chronic heart failure NYHA I-III.
- LVEF ≤40% documented in the echocardiography.
- Stable Heart Failure symptoms:
- Stable symptoms (subjectively declared by the patient) over the past three months.
- No increase in peripheral edema or body weight (declared by the patient).
- Loop diuretic dose equivalent to 80 mg of furosemide or 20 mg of torasemide daily, with no changes in the past three months.
Show all 12Show fewer
- Age over 18 and under 85 years.
- Male or female.
- Use of guideline-directed medical therapy (GDMT), with each drug group at maximum tolerated doses but no more than half of the maximum dose.
- Systolic blood pressure <100 mmHg and/or diastolic blood pressure <60 mmHg.
- Resting heart rate up to 80 bpm.
- Serum sodium concentration <140 mmol/L, regardless of the cause.
Who cannot join
- Hospitalization due to heart failure decompensation within the last three months.
- Primary hypertrophic or restrictive cardiomyopathy, constrictive pericarditis.
- Systemic disease known to be associated with cardiac muscle infiltration.
- Significant valvular disease (moderate or severe stenosis of any valve, moderate or severe aortic or pulmonary regurgitation, severe tricuspid or mitral regurgitation).
- Severe renal impairment (eGFR <30 mL/min/1.73 m² based on the MDRD formula).
- Stroke or transient ischemic attack (TIA) within the last three months.
Show all 14Show fewer
- Cardiac resynchronization therapy (CRT), ICD, ablation, or pacemaker implantation (or planned implantation) within the last three months.
- Severe lung disease or "cor pulmonale" or other causes of isolated right ventricular failure not associated with left ventricular dysfunction.
- Severe lung disease with respiratory failure requiring home oxygen therapy.
- Body weight <40 kg or ≥150 kg.
- Life expectancy <12 months according to the investigator's assessment
- Pregnancy or breastfeeding.
- Ongoing drug or alcohol abuse.
- Lactose intolerance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Institute of Heart Diseases, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, 50-536
About this study
Official title: Impact of Sodium Chloride Supplementation for Natriuresis, Blood Pressure and Neurohormonal Activity in Chronic Heart Failure With Reduced Ejection Fraction and Low Serum Sodium Concentration - Double-blinded, Placebo-controlled, Prospective Trial
The study is a single-center, prospective, randomized, placebo-controlled, double-blind trial conducted at the Institute of Heart Diseases and the Department of Cardiology of Wroclaw Medical University Hospital. It aims to evaluate the effects of three-month oral sodium chloride supplementation (3 g/day, equivalent to 1.2 g of sodium) versus placebo (lactose) in patients with chronic heart failure with reduced ejection fraction (HFrEF) and low serum sodium, who have not reached the maximum recommended doses of guideline-directed medical therapy (GDMT).
A total of 30 patients will be enrolled, with 15 randomized to the experimental group receiving sodium chloride and 15 to the control group receiving placebo. Patient selection will involve careful screening, including recent serum sodium measurements, to ensure all inclusion and exclusion criteria are met.
Read more
Participants will attend bi-weekly visits to assess clinical parameters (medical history, EVEREST heart failure symptoms score, blood pressure, body weight), biochemical markers (serum: morphology, urea, creatinine, sodium, chloride, potassium, NT-proBNP, aldosterone, renin; urine: urea, creatinine, sodium, chloride, potassium), and the safety of supplementation (body weight, serum sodium and chloride, exercise tolerance). Visits will also allow attempts to optimize GDMT doses where clinically feasible, based on objective criteria (e.g., systolic blood pressure >110 mmHg and/or diastolic blood pressure >60 mmHg).
Capsules containing sodium chloride or placebo will be prepared according to pharmacy standards to ensure intestinal release and maintain blinding. The Primary Investigator will remain blinded to treatment allocation. Follow-up will include both in-person and telephone visits, monitoring clinical status and safety parameters throughout the study period.
Sample size was calculated based on previous studies in this field, to achieve a type I error probability of 0.05 and a power of 0.80. At the end of the three-month supplementation, participants will undergo a comprehensive final assessment. Study data will be analyzed statistically to determine the effects of sodium chloride supplementation on natriuresis, blood pressure, neurohormonal activity, and the potential for optimizing GDMT in HFrEF patients with low serum sodium.
Read the detailed description
Heart failure (HF) is a complex clinical syndrome characterized by symptoms and signs resulting from structural and/or functional cardiac abnormalities that lead to elevated intracardiac pressure and/or reduced cardiac output at rest or during exertion. The pathophysiology of HF is strongly associated with neurohormonal activation, including increased activity of the renin-angiotensin-aldosterone system, vasopressin, endothelin, and natriuretic peptides. Pharmacological therapies targeting these pathways, collectively referred to as guideline-directed medical therapy (GDMT) in HF with reduced ejection fraction (HFrEF), significantly reduce mortality and unplanned hospitalizations when administered at recommended doses.
Despite advances in treatment, HF remains a progressive disease characterized by recurrent episodes of decompensation and poor long-term outcomes. Epidemiological data indicate that HF affects approximately 1-2% of the general population and is associated with high annual mortality and frequent hospital admissions. Neurohormonal disturbances contribute to sodium and water retention, leading to fluid accumulation and the need for diuretic therapy to restore euvolemia. Although diuretics effectively relieve congestion-related symptoms, they do not improve long-term outcomes and may contribute to electrolyte disturbances, particularly hyponatremia, which is itself associated with worse outcomes in advanced HF.
For many years, strict dietary sodium restriction was considered a cornerstone of HF management because excessive sodium intake was believed to promote fluid retention due to impaired renal autoregulation. However, recent evidence has challenged this paradigm. Studies conducted in the era of modern neurohormonal blockade have demonstrated that sodium restriction does not improve clinical outcomes in HF patients. The SODIUM-HF trial showed no clinical benefit from dietary sodium restriction, while other studies, including those by Dauw et al., demonstrated that oral sodium chloride supplementation of 3 g/day is safe in HF patients, does not increase fluid overload, and may improve natriuresis while reducing plasma renin activity.
At the same time, a major limitation of contemporary HF treatment remains the inability to achieve optimal GDMT dosing in many patients. Hypotension frequently prevents dose escalation or initiation of additional prognostically beneficial therapies, resulting in only approximately 40% of patients receiving all recommended medications at target doses. Therefore, strategies aimed at improving blood pressure stability and sodium balance may facilitate better optimization of HF therapy.
Based on these observations, the present study was designed to evaluate whether oral sodium chloride supplementation in patients with chronic HFrEF and low serum sodium levels may safely improve sodium handling, neurohormonal balance, blood pressure, and tolerance of GDMT. Additionally, the study aims to assess whether sodium supplementation may facilitate optimization of GDMT dosing in patients prone to hypotension.
This investigation is a single-center, prospective, randomized, placebo-controlled, double-blind trial conducted at the Institute of Heart Diseases and the Department of Cardiology of Wroclaw Medical University Hospital. Thirty patients with HFrEF, low serum sodium concentration, and suboptimal GDMT dosing will be enrolled. Participants will be randomly assigned 1:1 to one of two groups: an intervention group receiving oral sodium chloride supplementation (1 g NaCl capsules administered three times daily, totaling 3 g/day) or a placebo group receiving matching lactose capsules.
Eligibility will be confirmed through a detailed preselection process, including recent serum sodium measurements and baseline laboratory evaluation. After enrollment and informed consent, all participants will continue their current HF medications and habitual diet, without medication dose modifications during the first 14 days of supplementation. Throughout the study, patients will perform daily home measurements of blood pressure, heart rate, and body weight.
Scheduled follow-up visits will include clinical assessment of HF symptoms, anthropometric measurements, and laboratory analyses of serum and urinary electrolytes, renal function parameters, NT-proBNP, renin, and aldosterone concentrations. Safety monitoring will focus on body weight changes, exercise tolerance, blood pressure, and adherence to supplementation. Supplementation will be temporarily discontinued in cases of ≥2 kg body weight increase or worsening dyspnea/exercise tolerance. Compliance will be assessed using pill counts and patient diaries, and participants missing more than 10% of planned doses will be excluded from further analysis.
An additional objective of the study is to evaluate the feasibility of GDMT dose escalation during follow-up. Eligibility for treatment optimization will be determined using predefined blood pressure criteria, including systolic blood pressure >110 mmHg and/or diastolic blood pressure >60 mmHg, while maintaining patient safety and clinical stability.
The primary goals of the study are to assess the effects of oral sodium chloride supplementation on sodium retention, natriuresis, neurohormonal activity, blood pressure, and treatment safety in patients with HFrEF and low serum sodium levels. Secondary objectives include evaluation of the potential for GDMT optimization and comparison of outcomes between intervention and placebo groups, including subgroup analyses according to gender.
- Being tested
- Sodium chloride supplementation, Placebo administration
- Keywords
- sodium supplementation, sodium chloride, HFrEF, chronic heart failure, neurohormonal activity, aldosterone, renin, blood pressure, natriuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium chloride supplementationDietary supplement
Oral supplementation with sodium chloride capsules for three months at a total daily dose of 3 g (equivalent to 1.2 g of sodium). The planned regimen is one 1 g sodium chloride capsule taken three times daily.
Placebo administrationDietary supplement
Three-month oral administration of lactose as a placebo, matching the active treatment in appearance and dosing schedule. The planned regimen is one capsule containing lactose three times daily.
| Study group | Role | What they receive |
|---|---|---|
| Sodium chloride supplementation group | Experimental | Oral supplementation of sodium chloride Receives: Dietary Supplement: Sodium chloride supplementation |
| Placebo group | Placebo comparator | Placebo (lactose)administration Receives: Dietary Supplement: Placebo administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium Handling and Urine Dilution Response
Change in the degree of sodium retention (assessed as FeNa) and urine dilution (defined as urineary creatinine baseline to 3-h post-diuretic concentration) following administration of the patient's current diuretic dose in the sodium chloride supplementation group versus placebo group
Measured: 3 months observation - predefined timpoints
Plasma renin and aldosterone assessment
Assessment of changes in plasma renin and aldosterone concentrations during the study period in the sodium chloride supplementation group versus the placebo group.
Measured: 3 months observation - in predefined timepoints
Mean blood pressure trajectory
Mean blood pressure assessment during the study period in the sodium chloride supplementation group versus the placebo group
Measured: 3 months observation - in predefined timepoints
Body weight change assessment (safety measurement)
Long-term assessment of body weight increase between consecutive timepoints. Discontinuation of supplementation if weight increases by more than 2 kg between consecutive timepoints.
Measured: 6 months observation - in predefined timpeoints
Blood pressure assessment (safety assessment)
Assessment of blood pressure between consecutive timepoints. Discontinuation of supplementation if mean blood pressure decrease below 80/40 mmHg.
Measured: 6 moths observation - in predefined timepoints
Secondary outcomes (4)
NT-proBNP change
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration during the study period in the sodium chloride supplementation group versus the placebo group
Measured: 3 months - predefined timepoints
Serum sodium concentration change
Change in serum sodium concentration during the study period in the sodium chloride supplementation group versus the placebo group
Measured: 3 months - predefined timepoints
Congestion status change
Differences in congestion assesed in EVEREST congestion score (in points) - during the study period in the sodium chloride supplementation group versus the placebo group
Measured: 3 months - predefined timepoints
Possibility of GDMT optimization
Assessment of the possibility of up-titration of GDMT doses during the study, based on a mean increase in blood pressure of 5 mmHg, and physician opinion over the study period in the sodium chloride supplementation group compared with the placebo group.
Measured: 3 months - predefined timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startMay 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart Failure With Reduced Ejection FractionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Guzik, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614295
- Sponsor's protocol ID
- KB340/2025
- Other IDs
- 2024/53/N/NZ5/02590
- Acronym
- RESALT-CHF
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared through an IT system with controlled access, governed by appropriate authorization levels and in compliance with applicable data protection regulations. The shared data will be anonymized. Access to the data will be provided through the Polish Platform of Medical Research repository.
Publications
Ezekowitz JA, Colin-Ramirez E, Ross H, Escobedo J, Macdonald P, Troughton R, Saldarriaga C, Alemayehu W, McAlister FA, Arcand J, Atherton J, Doughty R, Gupta M, Howlett J, Jaffer S, Lavoie A, Lund M, Marwick T, McKelvie R, Moe G, Pandey AS, Porepa L, Rajda M, Rheault H, Singh J, Toma M, Virani S, Zieroth S; SODIUM-HF Investigators. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial. Lancet. 2022 Apr 9;399(10333):1391-1400. doi: 10.1016/S0140-6736(22)00369-5. Epub 2022 Apr 2.
PubMed 35381194Zhao W, Qin J, Lu G, Wang Y, Qiao L, Li Y. Association between hyponatremia and adverse clinical outcomes of heart failure: current evidence based on a systematic review and meta-analysis. Front Cardiovasc Med. 2023 Dec 22;10:1339203. doi: 10.3389/fcvm.2023.1339203. eCollection 2023.
PubMed 38204798Mullens W, Damman K, Dhont S, Banerjee D, Bayes-Genis A, Cannata A, Chioncel O, Cikes M, Ezekowitz J, Flammer AJ, Martens P, Mebazaa A, Mentz RJ, Miro O, Moura B, Nunez J, Ter Maaten JM, Testani J, van Kimmenade R, Verbrugge FH, Metra M, Rosano GMC, Filippatos G. Dietary sodium and fluid intake in heart failure. A clinical consensus statement of the Heart Failure Association of the ESC. Eur J Heart Fail. 2024 Apr;26(4):730-741. doi: 10.1002/ejhf.3244. Epub 2024 Apr 12.
PubMed 38606657Dauw J, Meekers E, Martens P, Deferm S, Dhont S, Marchal W, Mesotten L, Dupont M, Nijst P, Tang WHW, Janssens SP, Mullens W. Sodium loading in ambulatory patients with heart failure with reduced ejection fraction: Mechanistic insights into sodium handling. Eur J Heart Fail. 2024 Mar;26(3):616-624. doi: 10.1002/ejhf.3131. Epub 2024 Jan 21.
PubMed 38247136
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sodium Chloride Supplementation for Natriuresis, Blood Pressure and Neurohormonal Activity in Chronic Heart Failure With Reduced Ejection Fraction and Low Serum Sodium Concentration - Double-blinded, Placebo-controlled, Prospective Trial
- ClinicalTrials.gov ID
- NCT07614295
- Acronym / sponsor ID
- RESALT-CHF / KB340/2025
- Keywords
- sodium supplementation, sodium chloride, HFrEF, chronic heart failure, neurohormonal activity, aldosterone, renin, blood pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 May 2026 (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 study is a single-center, prospective, randomized, placebo-controlled, double-blind trial conducted at the Institute of Heart Diseases and the Department of Cardiology of Wroclaw Medical University Hospital. It aims to evaluate the effects of three-month oral sodium chloride supplementation (3 g/day, equivalent to 1.2 g of sodium) versus placebo (lactose) in patients with chronic heart failure with reduced ejection fraction (HFrEF) and low serum sodium, who have not reached the maximum recommended doses of guideline-directed medical therapy (GDMT).
A total of 30 patients will be enrolled, with 15 randomized to the experimental group receiving sodium chloride and 15 to the control group receiving placebo. Patient selection will involve careful screening, including recent serum sodium measurements, to ensure all inclusion and exclusion criteria are met.
Participants will attend bi-weekly visits to assess clinical parameters (medical history, EVEREST heart failure symptoms score, blood pressure, body weight), biochemical markers (serum: morphology, urea, creatinine, sodium, chloride, potassium, NT-proBNP, aldosterone, renin; urine: urea, creatinine, sodium, chloride, potassium), and the safety of supplementation (body weight, serum sodium and chloride, exercise tolerance). Visits will also allow attempts to optimize GDMT doses where clinically feasible, based on objective criteria (e.g., systolic blood pressure >110 mmHg and/or diastolic blood pressure >60 mmHg).
Capsules containing sodium chloride or placebo will be prepared according to pharmacy standards to ensure intestinal release and maintain blinding. The Primary Investigator will remain blinded to treatment allocation. Follow-up will include both in-person and telephone visits, monitoring clinical status and safety parameters throughout the study period.
Sample size was calculated based on previous studies in this field, to achieve a type I error probability of 0.05 and a power of 0.80. At the end of the three-month supplementation, participants will undergo a comprehensive final assessment. Study data will be analyzed statistically to determine the effects of sodium chloride supplementation on natriuresis, blood pressure, neurohormonal activity, and the potential for optimizing GDMT in HFrEF patients with low serum sodium.
Detailed description
Heart failure (HF) is a complex clinical syndrome characterized by symptoms and signs resulting from structural and/or functional cardiac abnormalities that lead to elevated intracardiac pressure and/or reduced cardiac output at rest or during exertion. The pathophysiology of HF is strongly associated with neurohormonal activation, including increased activity of the renin-angiotensin-aldosterone system, vasopressin, endothelin, and natriuretic peptides. Pharmacological therapies targeting these pathways, collectively referred to as guideline-directed medical therapy (GDMT) in HF with reduced ejection fraction (HFrEF), significantly reduce mortality and unplanned hospitalizations when administered at recommended doses.
Despite advances in treatment, HF remains a progressive disease characterized by recurrent episodes of decompensation and poor long-term outcomes. Epidemiological data indicate that HF affects approximately 1-2% of the general population and is associated with high annual mortality and frequent hospital admissions. Neurohormonal disturbances contribute to sodium and water retention, leading to fluid accumulation and the need for diuretic therapy to restore euvolemia. Although diuretics effectively relieve congestion-related symptoms, they do not improve long-term outcomes and may contribute to electrolyte disturbances, particularly hyponatremia, which is itself associated with worse outcomes in advanced HF.
For many years, strict dietary sodium restriction was considered a cornerstone of HF management because excessive sodium intake was believed to promote fluid retention due to impaired renal autoregulation. However, recent evidence has challenged this paradigm. Studies conducted in the era of modern neurohormonal blockade have demonstrated that sodium restriction does not improve clinical outcomes in HF patients. The SODIUM-HF trial showed no clinical benefit from dietary sodium restriction, while other studies, including those by Dauw et al., demonstrated that oral sodium chloride supplementation of 3 g/day is safe in HF patients, does not increase fluid overload, and may improve natriuresis while reducing plasma renin activity.
At the same time, a major limitation of contemporary HF treatment remains the inability to achieve optimal GDMT dosing in many patients. Hypotension frequently prevents dose escalation or initiation of additional prognostically beneficial therapies, resulting in only approximately 40% of patients receiving all recommended medications at target doses. Therefore, strategies aimed at improving blood pressure stability and sodium balance may facilitate better optimization of HF therapy.
Based on these observations, the present study was designed to evaluate whether oral sodium chloride supplementation in patients with chronic HFrEF and low serum sodium levels may safely improve sodium handling, neurohormonal balance, blood pressure, and tolerance of GDMT. Additionally, the study aims to assess whether sodium supplementation may facilitate optimization of GDMT dosing in patients prone to hypotension.
This investigation is a single-center, prospective, randomized, placebo-controlled, double-blind trial conducted at the Institute of Heart Diseases and the Department of Cardiology of Wroclaw Medical University Hospital. Thirty patients with HFrEF, low serum sodium concentration, and suboptimal GDMT dosing will be enrolled. Participants will be randomly assigned 1:1 to one of two groups: an intervention group receiving oral sodium chloride supplementation (1 g NaCl capsules administered three times daily, totaling 3 g/day) or a placebo group receiving matching lactose capsules.
Eligibility will be confirmed through a detailed preselection process, including recent serum sodium measurements and baseline laboratory evaluation. After enrollment and informed consent, all participants will continue their current HF medications and habitual diet, without medication dose modifications during the first 14 days of supplementation. Throughout the study, patients will perform daily home measurements of blood pressure, heart rate, and body weight.
Scheduled follow-up visits will include clinical assessment of HF symptoms, anthropometric measurements, and laboratory analyses of serum and urinary electrolytes, renal function parameters, NT-proBNP, renin, and aldosterone concentrations. Safety monitoring will focus on body weight changes, exercise tolerance, blood pressure, and adherence to supplementation. Supplementation will be temporarily discontinued in cases of ≥2 kg body weight increase or worsening dyspnea/exercise tolerance. Compliance will be assessed using pill counts and patient diaries, and participants missing more than 10% of planned doses will be excluded from further analysis.
An additional objective of the study is to evaluate the feasibility of GDMT dose escalation during follow-up. Eligibility for treatment optimization will be determined using predefined blood pressure criteria, including systolic blood pressure >110 mmHg and/or diastolic blood pressure >60 mmHg, while maintaining patient safety and clinical stability.
The primary goals of the study are to assess the effects of oral sodium chloride supplementation on sodium retention, natriuresis, neurohormonal activity, blood pressure, and treatment safety in patients with HFrEF and low serum sodium levels. Secondary objectives include evaluation of the potential for GDMT optimization and comparison of outcomes between intervention and placebo groups, including subgroup analyses according to gender.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium chloride supplementation group | Experimental | Dietary Supplement: Sodium chloride supplementationOral supplementation of sodium chloride |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo administrationPlacebo (lactose)administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Chronic heart failure NYHA I-III.
- LVEF ≤40% documented in the echocardiography.
- Stable Heart Failure symptoms:
- Age over 18 and under 85 years.
- Male or female.
Key exclusion criteria (14 listed)
- Hospitalization due to heart failure decompensation within the last three months.
- Primary hypertrophic or restrictive cardiomyopathy, constrictive pericarditis.
- Systemic disease known to be associated with cardiac muscle infiltration.
- Significant valvular disease (moderate or severe stenosis of any valve, moderate or severe aortic or pulmonary regurgitation, severe tricuspid or mitral regurgitation).
- Severe renal impairment (eGFR <30 mL/min/1.73 m² based on the MDRD formula).
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 chloride supplementationOral supplementation with sodium chloride capsules for three months at a total daily dose of 3 g (equivalent to 1.2 g of sodium). The planned regimen is one 1 g sodium chloride capsule taken three times daily. | Dietary supplement | Sodium chloride supplementation group |
| Placebo administrationThree-month oral administration of lactose as a placebo, matching the active treatment in appearance and dosing schedule. The planned regimen is one capsule containing lactose three times daily. | Dietary supplement | Placebo group |
Primary outcome
Sodium Handling and Urine Dilution Response
Time frame: 3 months observation - predefined timpoints
Change in the degree of sodium retention (assessed as FeNa) and urine dilution (defined as urineary creatinine baseline to 3-h post-diuretic concentration) following administration of the patient's current diuretic dose in the sodium chloride supplementation group versus placebo group
Plasma renin and aldosterone assessment
Time frame: 3 months observation - in predefined timepoints
Assessment of changes in plasma renin and aldosterone concentrations during the study period in the sodium chloride supplementation group versus the placebo group.
Mean blood pressure trajectory
Time frame: 3 months observation - in predefined timepoints
Mean blood pressure assessment during the study period in the sodium chloride supplementation group versus the placebo group
Body weight change assessment (safety measurement)
Time frame: 6 months observation - in predefined timpeoints
Long-term assessment of body weight increase between consecutive timepoints. Discontinuation of supplementation if weight increases by more than 2 kg between consecutive timepoints.
Blood pressure assessment (safety assessment)
Time frame: 6 moths observation - in predefined timepoints
Assessment of blood pressure between consecutive timepoints. Discontinuation of supplementation if mean blood pressure decrease below 80/40 mmHg.
4 secondary outcomes
NT-proBNP change
Time frame: 3 months - predefined timepoints
Serum sodium concentration change
Time frame: 3 months - predefined timepoints
Congestion status change
Time frame: 3 months - predefined timepoints
Possibility of GDMT optimization
Time frame: 3 months - predefined timepoints
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 35381194Ezekowitz JA, Colin-Ramirez E, Ross H, Escobedo J, Macdonald P, Troughton R, Saldarriaga C, Alemayehu W, McAlister FA, Arcand J, Atherton J, Doughty R, Gupta M, Howlett J, Jaffer S, Lavoie A, Lund M, Marwick T, McKelvie R, Moe G, Pandey AS, Porepa L, Rajda M, Rheault H, Singh J, Toma M, Virani S, Zieroth S; SODIUM-HF Investigators. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial. Lancet. 2022 Apr 9;399(10333):1391-1400. doi: 10.1016/S0140-6736(22)00369-5. Epub 2022 Apr 2.
- Background: PubMed 38204798Zhao W, Qin J, Lu G, Wang Y, Qiao L, Li Y. Association between hyponatremia and adverse clinical outcomes of heart failure: current evidence based on a systematic review and meta-analysis. Front Cardiovasc Med. 2023 Dec 22;10:1339203. doi: 10.3389/fcvm.2023.1339203. eCollection 2023.
- Background: PubMed 38606657Mullens W, Damman K, Dhont S, Banerjee D, Bayes-Genis A, Cannata A, Chioncel O, Cikes M, Ezekowitz J, Flammer AJ, Martens P, Mebazaa A, Mentz RJ, Miro O, Moura B, Nunez J, Ter Maaten JM, Testani J, van Kimmenade R, Verbrugge FH, Metra M, Rosano GMC, Filippatos G. Dietary sodium and fluid intake in heart failure. A clinical consensus statement of the Heart Failure Association of the ESC. Eur J Heart Fail. 2024 Apr;26(4):730-741. doi: 10.1002/ejhf.3244. Epub 2024 Apr 12.
- Background: PubMed 38247136Dauw J, Meekers E, Martens P, Deferm S, Dhont S, Marchal W, Mesotten L, Dupont M, Nijst P, Tang WHW, Janssens SP, Mullens W. Sodium loading in ambulatory patients with heart failure with reduced ejection fraction: Mechanistic insights into sodium handling. Eur J Heart Fail. 2024 Mar;26(3):616-624. doi: 10.1002/ejhf.3131. Epub 2024 Jan 21.
- Individual participant dataSharing planned: Yes. Data will be shared through an IT system with controlled access, governed by appropriate authorization levels and in compliance with applicable data protection regulations. The shared data will be anonymized. Access to the data will be provided through the Polish Platform of Medical Research repository.
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Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre
Heart Failure
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.
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 supplementation in people with Chronic Heart Failure With Reduced Ejection Fraction, run by Wroclaw Medical University at 1 site in Poland.
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 12 inclusion and 14 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: opening soon, as of the sponsor's last update on 29 May 2026. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mateusz Guzik M.G. Guzik, MD (+48 71 733 11 12, m.guzik@umw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sodium Handling and Urine Dilution Response (time frame: 3 months observation - predefined timpoints). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07614295, which also lists 4 linked publications.
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 29 May 2026.