effectiveness of low-salt bread on the total sodiumintake in patients with chronic heart failure

Completed

Conditions: chronic heart failure. heart failure
10019280

Registration Number: NL-OMON45077

Lead Sponsor: Viecuri Medisch Centrum voor Noord-Limburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 58

Inclusion Criteria

Age at least 18 years;
Estimated GFR (based on Modification of Diet in Renal Disease (MDRD) calculation) 15-45 ml/min/1.73m2, not receiving RRT
CHF NYHA III-IV, 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
Cognitive impairment
Blood pressure systolic below 110 mmHg or diastolic below 50 mmHg
Allergic reaction to mushrooms, silica , corn and gluten
Patients were excluded in the follow up period when diuretics were adjusted.
Hyper/hypo phosphatemia, potassium
Life expectancy shorter than 1 year
Suffering from a salt loosing nephropathy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is a reduction in daily salt intake, which will be<br /><br>measured by detection of sodium in the urine. There will also be a comparison<br /><br>with the food frequency questionnaire which the patients collect during several<br /><br>days. Our primary hypothesis is that a low sodium intake due to the low sodium<br /><br>bread will lead to an improvement of our secondary study parameters<br /><br><br /><br>We expect a reduction of daily salt intake of 1.5 gram sodium by an average of<br /><br>5 slices bread a day. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters will be:<br /><br>- Blood pressure<br /><br>- Protein in the urine<br /><br>- Quality of life<br /><br>- Body weight<br /><br>- Signs of heart failure - NYHA classification<br /><br>- body composition and fluid status (intra en extra cellulair) (this<br /><br>measurement will not be performed in patients wit a pacemaker or ICD) </p><br>