Weight Loss as Treatment in Heart Disease | NCT02105805

Studies
Weight Loss as Treatment in Heart Disease

NCT02105805

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Apr 7, 2014Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Heart Failure

Interventions

Dietetic group sessions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Mar 28, 2014

First Submission Date that Met QC Criteria

Apr 2, 2014

First Posted Date

Apr 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2014

Last Update Posted Date

Apr 7, 2014Estimated

Name	Class
University Hospital, Gentofte, Copenhagen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
low energy diet	Experimental	low energy diet treatment	Behavioral: Dietetic group sessions
Nordic recommendation	Active Comparator	Nordic recommendation, no restrictions on energy	Behavioral: Dietetic group sessions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietetic group sessions	Behavioral	Group sessions to improve dietary adherence	Nordic recommendation low energy diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in six minute walk test from baseline to week 16 (end of study)	Performance measure	weeks 0 and 16

Secondary Outcomes

Measure	Description	Time Frame
Change in lipid status from baseline to week 16 (end of study).	Blood sample and analyses for lipids	weeks 0,1,2,4,6,8,10,12,14,16

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided