Effects of Repletion of Sodium Chloride on Natriuresis, Blood Pressure, and Neurohormonal Activity in Patients With Chronic Heart Failure With Reduced Ejection Fraction

NCT07614295 · tracked via the Priya Life Science Poland tracker

Sponsor

Wroclaw Medical University

Phase

Not applicable

Started

2026-05

Last updated

2026-05-29

Condition(s) studied

Chronic Heart Failure With Reduced Ejection Fraction

Investigational drug(s) / intervention(s)

Sodium chloride supplementationPlacebo administration

Sodium chloride supplementation: 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 administration: 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 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. 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Chronic heart failure NYHA I-III. 2. LVEF ≤40% documented in the echocardiography. 3. 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. 4. Age over 18 and under 85 years. 5. Male or female. 6. Use of guideline-directed medical therapy (GDMT), with each drug group at maximum tolerated doses but no more than half of the maximum dose. 7. Systolic blood pressure \<100 mmHg and/or diastolic blood pressure \<60 mmHg. 8. Resting heart rate up to 80 bpm. 9. Serum sodium concentration \<140 mmol/L, regardless of the cause. Exclusion Criteria: 1. Hospitalization due to heart failure decompensation within the last three months. 2. Primary hypertrophic or restrictive cardiomyopathy, constrictive pericarditis. 3. Systemic disease known to be associated with cardiac muscle infiltration. 4. Significant valvular disease (moderate or severe stenosis of any valve, moderate or severe aortic or pulmonary regurgitation, severe tricuspid or mitral regurgitation). 5. Severe renal impairment (eGFR \<30 mL/min/1.73 m² based on the MDRD formula). 6. Stroke or transient ischemic attack (TIA) within the last three months. 7. Cardiac resynchronization therapy (CRT), ICD, ablation, or pacemaker implantation (or planned implantation) within the last three months. 8. Severe lung disease or "cor pulmonale" or other causes of isolated right ventricular failure not associated with left ventricular dysfunction. 9. Severe lung disease with respiratory failure requiring home oxygen therapy. 10. Body weight \<40 kg or ≥150 kg. 11. Life expectancy \<12 months according to the investigator's assessment 12. Pregnancy or breastfeeding. 13. Ongoing drug or alcohol abuse. 14. Lactose intolerance.

Primary outcome measure(s)

Sodium Handling and Urine Dilution Response — 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 — 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 — 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) — 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) — 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.

Trial sites (1)

Facility	City	Region	Status
Institute of Heart Diseases, Wroclaw Medical University	Wroclaw	Lower Silesian Voivodeship

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07614295 on ClinicalTrials.gov ↗ ← All trials in Poland