NCT04226755

Liberal Use of Sodium in Ambulatory Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Ziekenhuis Oost-Limburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sodium chloride	1 gram tid (with every meal)

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-01-13
• Last updated: 2023-06-22

Locations

1 site across 1 country: Belgium