Clinical trial NCT04226755: Liberal Use of Sodium in Ambulatory Heart Failure
Official title: Liberal Use of Sodium in Ambulatory Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Sodium
Salt
Heart Failure
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in skin glycosaminoglycan (GAG) content
timeFrame: 4 weeks
measure: Changes in skin sodium content
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in blood volume assessed by radiolabeled red blood cell technique
timeFrame: 4 weeks
measure: Changes in extracellular, intravascular volume and total body fluid volume (assessed with bioimpedance)
timeFrame: 6 weeks
measure: Changes in renal sodium handling
timeFrame: 6 weeks
measure: Changes in cardiac geometry assessed by echo
timeFrame: 6 weeks
measure: Changes in renal venous flow pattern
timeFrame: 6 weeks
Other outcomes:
measure: Changes in Everest congestion score
timeFrame: 6 weeks
measure: Changes in weight
timeFrame: 6 weeks
measure: Changes in blood pressure
timeFrame: 6 weeks
measure: Changes in thirst visual analogue scale (VAS)
timeFrame: 6 weeks
measure: Changes in aldosterone
timeFrame: 6 weeks
measure: Changes in renin
timeFrame: 6 weeks
measure: Changes in N-terminal (NT)-pro hormone BNP (NT-proBNP)
timeFrame: 6 weeks
measure: Occurrence of congestion
timeFrame: 4 weeks
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Jeroen Dauw, MD
role: PRINCIPAL_INVESTIGATOR
References: