Liberal Use of Sodium in Ambulatory Heart Failure (LUSA-HF)

June 20, 2023 updated by: Wilfried Mullens, Ziekenhuis Oost-Limburg
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 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

  2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heart failure
After a run-in phase of 2 weeks, patients will add 3 g of sodium chloride to every meal, using a NaCl tablet of 1 g. They will continue the sodium tablet for 4 weeks with a study visit every 2 weeks. A skin biopsy will be performed before the start of the augmented salt intake and after 4 weeks.
Dietary supplement: Sodium chloride
1 gram tid (with every meal)
Active Comparator: Healthy volunteer
After a run-in phase of 2 weeks, volunteers will add 3 g of sodium chloride to every meal, using a NaCl tablet of 1 g. They will continue the sodium tablet for 4 weeks with a study visit every 2 weeks.A skin biopsy will be performed before the start of the augmented salt intake and after 4 weeks.
Dietary supplement: Sodium chloride
1 gram tid (with every meal)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in skin glycosaminoglycan (GAG) content
Time Frame: 4 weeks
4 weeks
Changes in skin sodium content
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in blood volume assessed by radiolabeled red blood cell technique
Time Frame: 4 weeks
4 weeks
Changes in extracellular, intravascular volume and total body fluid volume (assessed with bioimpedance)
Time Frame: 6 weeks
6 weeks
Changes in renal sodium handling
Time Frame: 6 weeks
6 weeks
Changes in cardiac geometry assessed by echo
Time Frame: 6 weeks
6 weeks
Changes in renal venous flow pattern
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 weeks
Changes in weight
Time Frame: 6 weeks
6 weeks
Changes in blood pressure
Time Frame: 6 weeks
6 weeks
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.
6 weeks
Changes in aldosterone
Time Frame: 6 weeks
6 weeks
Changes in renin
Time Frame: 6 weeks
6 weeks
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
6 weeks
Occurrence of congestion
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziekenhuis Oost-Limburg

Investigators

  • Principal Investigator: Jeroen Dauw, MD, Ziekenhuis Oost-Limburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZOLCAR19001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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