Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
NCT Number: NCT04226755
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Genk, 3600, Belgium
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 gram tid (with every meal)
Time frame: 4 weeks
Time frame: 4 weeks
Time frame: 4 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
The Everest score assesses congestion, based on a point scale with a range from 0 (no congestion) to 18 (worst congestion)
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
The scale ranges from 0 -100 with 0 indicating no thirst and 100 the worst thirst.
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
NT-proBNP will be measured using Roche diagnostics assay (Mannhein, Germany) and expresed as picogram per liter
Time frame: 4 weeks
Ziekenhuis Oost-Limburg
Other
Acronym: LUSA-HF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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