Heart Failure, Systolic Clinical Trial
Official title:
Effectiveness of Low-salt Bread on the Total Sodium Intake in Patients With Chronic Heart Failure and Chronic Kidney Disease (LoSa Pilot Study)
Verified date | January 2021 |
Source | VieCuri Medical Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
SUMMARY Rationale Patients with heart failure may suffer from a poor quality of life (QoL) due to frequent hospital admittance, medication intake, and symptoms as a result of progression of their disease. The general salt intake in the Dutch population is too high, leading indirectly to hypertension resulting in worsening of cardiovascular disease such as heart failure. Patients with heart failure are highly salt sensitive. A quarter of the daily salt intake originates from bread. Salt restriction is difficult to maintain. The aim of this study is to lower the daily salt intake by providing a palatable low salt bread to patients with heart failure. This may lead to a stable disease and therefore an improvement in quality of life. Objective The aim of this study is to investigate whether substitution of normal bread by a new palatable form of low salt bread is effective in reducing salt intake in patients with chronic heart failure. The investigators will evaluate the effectiveness, the compliance and the outcome of the presumed salt reduction. Study design This is a single center, randomized, double blinded, cross-over trial with a follow-up period of twelve weeks performed in VieCuri, Medical Centre in Venlo. Study population In this study, 20 patients visiting the outpatient clinic with heart failure NYHA class 3-4 will be included. All patients are 18 years or older. Intervention Given the study design all 20 patients receive a low salt bread (0.05 gram sodium per slice) for one period and received bread with a normal amount of sodium (0.35 gram sodium per slice) in the other period. After six weeks follow up, the groups change the intervention. Main study parameters/endpoints The investigators expect a reduction of daily salt intake of 1.5 gram sodium by an average of 5 slices bread a day. Nature and extent of the burden and risks associated with participation, benefit and group relatedness Patients should visit the hospital three times. Prior the hospital visit they have to collect 24- hour urine. During all visits blood samples will be taken and a physical exam is performed. Also blood pressure will be measured. Most of these parameters are also collected for clinical purposes. Patients should at the same time report their daily intake in a personal food diary and fill in questionnaires about their opinion of the bread and quality of life.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 1, 2020 |
Est. primary completion date | August 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age at least 18 years; - CHF NYHA III-IV or LVEF <35%, stable condition on optimal medical therapy: no medication changes in last two weeks prior to start study. - Written informed consent - Speak and read Dutch Exclusion Criteria: - Pregnancy or breastfeeding - Participating in any other interventional research study during the same period - Hyponatremia; sodium < 130 mmol/L - Hypokaliemia < 3.4 mmol/l - Hyperkaliemia > 5.5 mmol/l - Cognitive impairment - Blood pressure systolic below 100 mmHg OR diastolic below 50 mmHg - Allergic reaction to mushrooms, silica, corn and gluten - Life expectancy shorter than one year |
Country | Name | City | State |
---|---|---|---|
Netherlands | ViecuriMC | Venlo | Limburg |
Lead Sponsor | Collaborator |
---|---|
VieCuri Medical Centre |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sodium excretion urine | 24-hour urine sample will be analysed on sodium excretion. This will be measured at baseline and after each 6 week period.
Also sodium, protein, albumin and creatinine concentration will be measured. |
6 weeks | |
Secondary | Blood samples | the effect of the presumed lower salt intake, blood samples will be taken to measure sodium, potassium, creatinine and NT-proBNP. This will be measured at baseline and after each 6 week period. | 6 weeks | |
Secondary | Sodium intake | Subjects are asked to fill in a personal food diary. One day a week for 12 weeks. Sodium intake will be measured'. | 12 weeks. | |
Secondary | Taste of bread | During visits patients are asked about taste of bread via a questionnaire | 6 weeks | |
Secondary | Quality of Life Questionnaire | During visits patients are asked about QOL via a questionnaire | 6 weeks | |
Secondary | Blood pressure | During visits blood pressure will be measured non-invasively for 15 minutes. at baseline and at the end of each intervention | 6 weeks | |
Secondary | Body composition measurement with bioimpedance spectroscopy (BIS) | During visits excess fluid state (in Liters) will be measured non-invasively by applying the BCM Fresenius. | 6 weeks |
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