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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
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 28, 2014
    Last Updated
    April 2, 2014
    Sponsor
    University of Copenhagen
    Collaborators
    University Hospital, Gentofte, Copenhagen
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    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

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    Weight Loss as Treatment in Heart Disease

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