Heart Failure
Conditions
Keywords
intention weight loss, heart failure, 6-minute walk test
Brief summary
30 obese moderate-to-severe heart failure patients will be randomized to intervention or control in groups of 5-10 subjects. All will receive dietetic advice according to randomization and according to the European Heart Association. Intervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d substituting two daily meals with formula meal replacement. Control subjects are advised to follow the Nordic Nutrition Recommendations. Patients will be monitored by blood sampling and assessed by change in physical performance.
Interventions
BEHAVIORALDietetic group sessions
Group sessions to improve dietary adherence
Sponsors
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* bmi \>30 * heart failure, moderate to severe, new york heart association II og III * stable disease * age \>18 years * out-patients * perform a six minutes walk test * given consent
Exclusion criteria
* unstable disease * insulin treated diabetes * pregnancy or lactating * unstable weight past 6 months (+- 10 kg) * planned procedures in the time of intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in six minute walk test from baseline to week 16 (end of study) | weeks 0 and 16 | Performance measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in lipid status from baseline to week 16 (end of study). | weeks 0,1,2,4,6,8,10,12,14,16 | Blood sample and analyses for lipids |
Outcome results
None listed