Salt capsules for people with heart failure and low blood sodium

Trial details

Who runs it

Wroclaw Medical University

Trial code

NCT07614295

Record updated

29 May 2026

Original description

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).Read full original descriptionShow less

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.

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.

Inclusion: 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; 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.

Exclusion: Ongoing drug or alcohol abuse; Hospitalization due to heart failure decompensation within the last three months; 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); Stroke or transient ischemic attack (TIA) within the last three months; 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; Severe renal impairment (eGFR <30 mL/min/1.73 m² based on the MDRD formula); Primary hypertrophic or restrictive cardiomyopathy, constrictive pericarditis; Body weight <40 kg or ≥150 kg; Life expectancy <12 months according to the investigator's assessment; Pregnancy or breastfeeding; Lactose intolerance.

ClinicalTrials.gov NCT07614295