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

Patients with heart failure may suffer from a poor quality of life (QoL) due to
frequent hospital admittance, medication intake and as a result of symptoms and
progression of their disease. The general salt intake in the Dutch population
is too high, which can indirectly lead to cardiovascular disease such as heart
failure and renal failure. Patients with heart failure are highly salt
sensitive.
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 of quality of life.

The aim of this pilot study is to investigate whether substitution of normal
bread by a new palatable form of low salt bread is effective in reducing the
daily salt intake in patients with CHF. Furthermore the influence of the
presumed salt reduction on body composition, body weight, protein in urine and
blood pressure will be measured.

The following research questions will be evaluated:
1. Effectiveness: Does low salt bread reduce the daily salt intake?
2. Compliance: Is low salt bread tolerated?
3. Outcome: What is the effect of low salt bread on body-composition, blood
pressure and bodyweight, quality of life, protein in the urine?

Primary objective is the reduction in salt intake, by measuring the 24-h urine
sodium excretion. The secondary objectives are the effects of a lower salt
intake on blood pressure measured during 15 minutes, symptoms of heart failure
(dyspnoea, oedema, NYHA class), proteinuria, body composition and feasibility
of a new developed tasty low-salt bread.

This Pilot study will be a randomized single-centre cross-over study, performed
at the department of Cardiology of the VieCuri Medical Centre. The study has to
be approved by the Maastricht University Medical Centre METC.
After approval by MUMC Medical Ethical Committee the institutional ethics
committee of Viecuri MC will evaluate the feasibility of the study.

Study design:
After baseline measurements (primary aetiology of disease, age, height, weight,
BMI, medication) are taken, participants will be counseled to follow a regular
low-sodium diet (goal 80-100 mmol = 5-6 gram salt) as normally performed in the
interest of the patients disease. Dietary education will be individualized to
the participant' s food preferences and was provided by an accredited
practicing dietitian.

After including 20 patients with heart failure, an interim analysis will be
performed to evaluate the feasibility of significant differences and sample
size re estimation if needed.

After a two-week run-in period on a low-sodium diet, participants will be
randomized to the normal bread consuming group or the low salt bread group.
After the six week follow up (continued with the general low-sodium diet),
patients cross over to the other intervention group.

Participants, investigators, and outcome assessors will be blinded to the
allocation.

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 groups change the intervention.

Participants will be informed about the low salt diet for patients with heart
failure. After this, they will be randomized in the different intervention
groups:
- Group 1: will receive the Scelta bread with a normal amount of sodium (0.4
gram Sodium)
- Group 2: will receive the Scelta bread with a low amount of sodium (0.1 gram
Sodium).

Patients should visit the hospital three times. During all visits blood samples
will be taken and a physical exam is performed. Prior the hospital visit they
have to collect urine during 24hour. Also a 15 minutes blood pressure will be
measured. Most of these parameters will also be collected for regular
clinical-care purposes. Patients should also report their daily intake in a
personal food diary and fill in questionnaires about their opinion of the bread
and quality of life.