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

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.

Conditions

• Chronic Heart Failure With Reduced Ejection Fraction

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• Wroclaw Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2028-04-30

Completion

2028-07-31

Countries

• Poland

Study Locations