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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04226755
Study type Interventional
Source Ziekenhuis Oost-Limburg
Contact
Status Completed
Phase N/A
Start date June 1, 2020
Completion date June 30, 2022

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