Weight Loss as Treatment in Heart Disease
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dietetic group sessions
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring intention weight loss, heart failure, 6-minute walk test
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
low energy diet
Nordic recommendation
Arm Description
low energy diet treatment
Nordic recommendation, no restrictions on energy
Outcomes
Primary Outcome Measures
Change in six minute walk test from baseline to week 16 (end of study)
Performance measure
Secondary Outcome Measures
Change in lipid status from baseline to week 16 (end of study).
Blood sample and analyses for lipids
Full Information
NCT ID
NCT02105805
First Posted
March 28, 2014
Last Updated
April 2, 2014
Sponsor
University of Copenhagen
Collaborators
University Hospital, Gentofte, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT02105805
Brief Title
Weight Loss as Treatment in Heart Disease
Official Title
Intentional Weight Loss as Treatment in Obese Patients With Ischaemic Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
University Hospital, Gentofte, Copenhagen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
intention weight loss, heart failure, 6-minute walk test
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low energy diet
Arm Type
Experimental
Arm Description
low energy diet treatment
Arm Title
Nordic recommendation
Arm Type
Active Comparator
Arm Description
Nordic recommendation, no restrictions on energy
Intervention Type
Behavioral
Intervention Name(s)
Dietetic group sessions
Intervention Description
Group sessions to improve dietary adherence
Primary Outcome Measure Information:
Title
Change in six minute walk test from baseline to week 16 (end of study)
Description
Performance measure
Time Frame
weeks 0 and 16
Secondary Outcome Measure Information:
Title
Change in lipid status from baseline to week 16 (end of study).
Description
Blood sample and analyses for lipids
Time Frame
weeks 0,1,2,4,6,8,10,12,14,16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Weight Loss as Treatment in Heart Disease
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