NCT02013739

Brief Summary

The purpose of this study is to describe insulin resistance in a general chronic heart failure population, in combination with muscle strength, body composition and cardiac function. It is assumed that insulin resistance is increased in CHF patient, and that this is related to decreased muscle strength and decreased lean tissue mass.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

1.6 years

First QC Date

December 8, 2013

Last Update Submit

December 11, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance

    glucose and insulin concentration measurements in blood during oral glucose tolerance test

    day1

Secondary Outcomes (5)

  • HbA1c, blood lipids, BNP

    day 1

  • Muscle strength: maximal strength tested on a isokinetic dynamometer

    Day 1

  • Body composition: dual energy x-ray absorptiometry

    Day 1

  • cardiac function: echocardiography, retrospective from hospital files

    retrospective

  • Health-related quality of life: MLHFQ and Eq5d

    Day 1

Study Arms (2)

Patients with chronic heart failure

other

Healthy volontiers

other

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with chronic heart failure

You may qualify if:

  • diagnosis of chronic heart failure for at least 6 months,
  • clinically stable (not hospitalized) for more than 3 months prior to the onset of the study,

You may not qualify if:

  • glucose lowering medical therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Hasselt, Limburg, 3500, Belgium

Location

Study Officials

  • Bert Op 't Eijnde, prof. dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

December 8, 2013

First Posted

December 17, 2013

Study Start

May 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations