Liberal Use of Sodium in Ambulatory Heart Failure
- Conditions
- Heart Failure
- Interventions
- Dietary Supplement: Sodium chloride
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
-
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
- 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
- Arm && Interventions
Group Intervention Description Heart failure Sodium chloride 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. Healthy volunteer Sodium chloride 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.
- 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 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
Trial Locations
- Locations (1)
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium