Liberal Use of Sodium in Ambulatory Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT04226755
• Lead Sponsor: Ziekenhuis Oost-Limburg

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.

Study Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Study Start: 2020-06-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in skin sodium content	4 weeks
Changes in skin glycosaminoglycan (GAG) content	4 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium