NCT02105805

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable heart-failure

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
Last Updated

April 7, 2014

Status Verified

April 1, 2014

Enrollment Period

10 months

First QC Date

March 28, 2014

Last Update Submit

April 2, 2014

Conditions

Heart Failure

Keywords

intention weight lossheart failure6-minute walk test

Outcome Measures

Primary Outcomes (1)

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

    Performance measure

    weeks 0 and 16

Secondary Outcomes (1)

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

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

Study Arms (2)

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

Dietetic group sessionsBEHAVIORAL

Group sessions to improve dietary adherence

Nordic recommendationlow energy diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • unstable disease
  • insulin treated diabetes
  • pregnancy or lactating
  • unstable weight past 6 months (+- 10 kg)
  • planned procedures in the time of intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2014

First Posted

April 7, 2014

Study Start

October 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 7, 2014

Record last verified: 2014-04