Weight Loss as Treatment in Heart Disease

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietetic group sessions

Behavioral

Group sessions to improve dietary adherence

Primary outcomes

Change in six minute walk test from baseline to week 16 (end of study)

Time frame: weeks 0 and 16

Performance measure

Secondary outcomes

Change in lipid status from baseline to week 16 (end of study).

Time frame: weeks 0,1,2,4,6,8,10,12,14,16

Blood sample and analyses for lipids

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

University Hospital, Gentofte, Copenhagen

Registry information

Official study title

Intentional Weight Loss as Treatment in Obese Patients With Ischaemic Heart Disease

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Apr 7, 2014
Registry last updated: Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed