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.
Chronic heart failure NYHA I-III.
LVEF ≤40% documented in the echocardiography.
Stable symptoms (subjectively declared by the patient) over the past three months.
No increase in peripheral edema or body weight (declared by the patient).
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).
Parallel
Sodium chloride supplementation
Dietary supplementOral 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
Dietary supplementThree-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.
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
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.
Mean blood pressure trajectory
Mean blood pressure assessment during the study period in the sodium chloride supplementation group versus the placebo group
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.
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
Serum sodium concentration change
Change in serum sodium concentration during the study period in the sodium chloride supplementation group versus the placebo group
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
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.
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