Liberal Use of Sodium in Ambulatory Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Changes in skin sodium content
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Changes in skin sodium content
Time Frame: 4 weeks
Changes in skin glycosaminoglycan (GAG) content
Time Frame: 4 weeks
Secondary Outcomes
- Changes in cardiac geometry assessed by echo(6 weeks)
- Changes in extracellular, intravascular volume and total body fluid volume (assessed with bioimpedance)(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)
Investigators
Wilfried Mullens
Principal investigator
Ziekenhuis Oost-Limburg