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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart failure | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium chloride | Dietary Supplement | 1 gram tid (with every meal) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in skin glycosaminoglycan (GAG) content | 4 weeks | |
| Changes in skin sodium content | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood volume assessed by radiolabeled red blood cell technique | 4 weeks | |
| Changes in extracellular, intravascular volume and total body fluid volume (assessed with bioimpedance) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Everest congestion score | The Everest score assesses congestion, based on a point scale with a range from 0 (no congestion) to 18 (worst congestion) | 6 weeks |
| Changes in weight | 6 weeks |
Inclusion Criteria:
Heart failure patients:
Healthy volunteers:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeroen Dauw, MD | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Changes in renal sodium handling | 6 weeks |
| Changes in cardiac geometry assessed by echo | 6 weeks |
| Changes in renal venous flow pattern | 6 weeks |
| Changes in blood pressure | 6 weeks |
| Changes in thirst visual analogue scale (VAS) | The scale ranges from 0 -100 with 0 indicating no thirst and 100 the worst thirst. | 6 weeks |
| Changes in aldosterone | 6 weeks |
| Changes in renin | 6 weeks |
| Changes in N-terminal (NT)-pro hormone BNP (NT-proBNP) | NT-proBNP will be measured using Roche diagnostics assay (Mannhein, Germany) and expresed as picogram per liter | 6 weeks |
| Occurrence of congestion | 4 weeks |
| D017670 |
| Sodium Compounds |