NCT04226755

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

2.1 years

First QC Date

January 9, 2020

Last Update Submit

June 20, 2023

Conditions

Heart Failure

Keywords

SodiumSaltHeart Failure

Outcome Measures

Primary Outcomes (2)

  • Changes in skin glycosaminoglycan (GAG) content

    4 weeks

  • Changes in skin sodium content

    4 weeks

Secondary Outcomes (5)

  • Changes in blood volume assessed by radiolabeled red blood cell technique

    4 weeks

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

    6 weeks

  • Changes in renal sodium handling

    6 weeks

  • Changes in cardiac geometry assessed by echo

    6 weeks

  • Changes in renal venous flow pattern

    6 weeks

Other Outcomes (8)

  • Changes in Everest congestion score

    6 weeks

  • Changes in weight

    6 weeks

  • Changes in blood pressure

    6 weeks

  • +5 more other outcomes

Study Arms (2)

Heart failure

EXPERIMENTAL

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

Healthy volunteer

ACTIVE COMPARATOR

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

Interventions

Sodium chlorideDIETARY_SUPPLEMENT

1 gram tid (with every meal)

Healthy volunteerHeart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure patients:
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jeroen Dauw, MD

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 13, 2020

Study Start

June 1, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

BE(1)