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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45077
Enrollment
58
Registered
2015-12-09
Start date
2018-02-20
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic heart failure. heart failure

Interventions

29 Patients receive a low salt bread (0.1 gram sodium per slice) and another 29 patients receive bread with a normal amount of sodium (0.4 gram sodium per slice). After six weeks follow up, the grou

Sponsors

Viecuri Medisch Centrum voor Noord-Limburg
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Pregnancy or breastfeeding Participating in any other interventional research study during the same period Hyponatremia; sodium

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)