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Completed

NCT Number: NCT04226755

Liberal Use of Sodium in Ambulatory Heart Failure

This study investigates the effects of an increased sodium intake in heart failure patients with reduced ejection fraction and age-matched volunteers without heart failure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

About this study

At the start of the study, baseline investigations are performed including assessment of vital signs (blood pressure, heart rate, pulse oxygen saturation), weight, Everest congestion score (consisting of grading of dyspnea, orthopnea, jugular venous distention, rales, edema and fatigue), echocardiography, 24h urine collection, bio-impedance measurements and blood sample analysis with plasma renin and aldosterone Subsequently, a run-in phase of 2 weeks, without intervention, will start. After this run-in period, participants will be reassessed with the same baseline investigations. In addition, a skin biopsy will be performed as well as a blood volume measurement.

In the next phase of the study, salt intake will be increased with 3 grams daily. The salt will be packed in capsules containing 1 g of sodium chloride (NaCl). Patients will be asked to take one capsule with their breakfast, lunch and dinner. Every 2 weeks a follow-up visit is planned.

After 4 weeks of increased salt intake, a new skin biopsy will be taken and a blood volume measurement will be performed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Heart failure patients:
  • Left ventricular ejection fraction ≤40% on echocardiogram obtained at inclusion
  • Stable dose of guideline-recommended disease modifying drugs for at least 3 months.
  • Maximum daily loop diuretic dose of 40 mg furosemide equivalents with a stable dose for the last month
  • Healthy volunteers:
  • Age > 60 y
  • Normal ejection fraction (>50%) without heart failure
  • No neurohormonal blockers for hypertension
  • Normal NT-proBNP

Exclusion criteria

  • Heart failure hospitalization for congestion or myocardial infarction in past 3 months
  • Permanent atrial fibrillation
  • New York Heart Association (NYHA) class III-IV
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min
  • Signs of congestion
  • Severe right ventricular dysfunction
  • Severe valvular disease
  • Cardiothoracic anatomy not allowing satisfactory and reproducible recordings of echocardiogram
  • Inability to fully comprehend and/or perform study procedures in the investigator's opinion.

Treatment and study plan

Sodium chloride

Dietary Supplement

1 gram tid (with every meal)

Primary outcomes

  1. Changes in skin glycosaminoglycan (GAG) content

    Time frame: 4 weeks

  2. Changes in skin sodium content

    Time frame: 4 weeks

Secondary outcomes

  1. Changes in blood volume assessed by radiolabeled red blood cell technique

    Time frame: 4 weeks

  2. Changes in extracellular, intravascular volume and total body fluid volume (assessed with bioimpedance)

    Time frame: 6 weeks

  3. Changes in renal sodium handling

    Time frame: 6 weeks

  4. Changes in cardiac geometry assessed by echo

    Time frame: 6 weeks

  5. Changes in renal venous flow pattern

    Time frame: 6 weeks

Other outcomes

  1. Changes in Everest congestion score

    Time frame: 6 weeks

    The Everest score assesses congestion, based on a point scale with a range from 0 (no congestion) to 18 (worst congestion)

  2. Changes in weight

    Time frame: 6 weeks

  3. Changes in blood pressure

    Time frame: 6 weeks

  4. Changes in thirst visual analogue scale (VAS)

    Time frame: 6 weeks

    The scale ranges from 0 -100 with 0 indicating no thirst and 100 the worst thirst.

  5. Changes in aldosterone

    Time frame: 6 weeks

  6. Changes in renin

    Time frame: 6 weeks

  7. Changes in N-terminal (NT)-pro hormone BNP (NT-proBNP)

    Time frame: 6 weeks

    NT-proBNP will be measured using Roche diagnostics assay (Mannhein, Germany) and expresed as picogram per liter

  8. Occurrence of congestion

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Acronym: LUSA-HF

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2020
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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