Heart Failure
Conditions
Keywords
Sodium, Salt, Heart Failure
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.
Interventions
DIETARY_SUPPLEMENTSodium chloride
1 gram tid (with every meal)
Sponsors
Ziekenhuis Oost-Limburg
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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 2. Healthy volunteers: * Age \> 60 y * Normal ejection fraction (\>50%) without heart failure * No neurohormonal blockers for hypertension * Normal NT-proBNP
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in skin glycosaminoglycan (GAG) content | 4 weeks |
| Changes in skin sodium content | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in renal sodium handling | 6 weeks |
| Changes in blood volume assessed by radiolabeled red blood cell technique | 4 weeks |
| Changes in renal venous flow pattern | 6 weeks |
| Changes in cardiac geometry assessed by echo | 6 weeks |
| Changes in extracellular, intravascular volume and total body fluid volume (assessed with bioimpedance) | 6 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Everest congestion score | 6 weeks | The Everest score assesses congestion, based on a point scale with a range from 0 (no congestion) to 18 (worst congestion) |
| Occurrence of congestion | 4 weeks | — |
| Changes in weight | 6 weeks | — |
| Changes in blood pressure | 6 weeks | — |
| Changes in thirst visual analogue scale (VAS) | 6 weeks | The scale ranges from 0 -100 with 0 indicating no thirst and 100 the worst thirst. |
| Changes in aldosterone | 6 weeks | — |
| Changes in renin | 6 weeks | — |
| Changes in N-terminal (NT)-pro hormone BNP (NT-proBNP) | 6 weeks | NT-proBNP will be measured using Roche diagnostics assay (Mannhein, Germany) and expresed as picogram per liter |
Countries
Belgium
Outcome results
None listed