Low-salt Bread in Heart Failure, Pilot Study

NCT05589428 | Completed

• 2 other identifiers: NL47820.068.1447820.068.14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure, Systolic; Sodium Imbalance; Food Selection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Blood samples

  6 weeks

• Sodium intake

  12 weeks.

• Taste of bread

  6 weeks

• Quality of Life Questionnaire

  6 weeks

• Blood pressure

  6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal bread

Other: Placebo

Low sodium bread

EXPERIMENTAL

Low sodium bread

Dietary Supplement: Low sodium bread

Interventions

Low sodium bread DIETARY_SUPPLEMENT

Bread low in sodium

Low sodium bread

Placebo OTHER

Normal bread from bakery

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VieCuri Medical Centre: lead

Study Sites (1)

ViecuriMC

Venlo, Limburg, 5912 BL, Netherlands

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Food Preferences

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Feeding Behavior; Behavior

Study Officials

• Joan Meeder, MD PhD

  VieCuri Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: October 21, 2022
• Study Start: February 20, 2018
• Primary Completion: August 12, 2019
• Study Completion: January 1, 2020
• Last Updated: November 28, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)