Weight Loss as Treatment in Heart Disease

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105805
• Other study ID #: GEN-01-clinnutr
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: April 2, 2014
• Start date: October 2010
• Est. completion date: August 2011

Study information

• Verified date: April 2014
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Diseases
• Heart Failure
• Weight Loss

Intervention

Behavioral:
• Dietetic group sessions
Group sessions to improve dietary adherence

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	University Hospital, Gentofte, Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in six minute walk test from baseline to week 16 (end of study)	Performance measure	weeks 0 and 16	No
Secondary	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	No