NCT01014611

Brief Summary

The aim of this project is to investigate the impact of heart failure (HF) on calcium homeostasis, mitochondrial function and oxidative stress in human skeletal muscle, before and after exercise training. The role playing by circulating factors such as cytokines and catecholamines will also be evaluated. 24 HF patients will be enrolled in the study: 12 class II NYHA HF volunteers with a fraction of ejection between 40% and 30 %, and 12 class III NYHA HF volunteers with a fraction of ejection lower than 30 %. They will be compared to 24 sedentary healthy volunteers, matched on age and physical activity.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

First QC Date

November 16, 2009

Last Update Submit

September 26, 2012

Conditions

Heart Failure

Keywords

Heart failureSkeletal muscleCalciumRyanodine receptorMitochondriaExercise trainingMuscle biopsyHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • To evaluate the skeletal muscular function (calcium homeostasis, mitochondrial function and oxidative stress) in two stages of heart failure patients compared to healthy volunteers

    Baseline measurement

Secondary Outcomes (2)

  • To analyse the link between the hypothetical skeletal muscular function in two stages of heart failure and circulating factors such as cytokines and catecholamines

    Baseline measurement

  • To investigate the effect of exercise training on skeletal muscular hypothetical dysfunction in two stages of heart failure patients

    10 weeks

Study Arms (3)

Class II NYHA Heart Failure

Fraction of ejection between 40% and 30%

Class III NYHA Heart Failure

Fraction of ejection lower than 30%

Healthy volunteers

Matched with patients on age and physical activity

Eligibility Criteria

Age35 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

24 heart failure patients: 12 class II NYHA with a fraction of ejection between 40% and 30% and 12 class III NYHA with a fraction of ejection lower than 30% 24 sedentary healthy male volunteers matched to patients on age and physical activity

You may qualify if:

  • BMI \< 30

You may not qualify if:

  • Contra-indication to exercise testing performance and muscle biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional Universitaire

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Florence Galtier, MD

    CHRU de Montpellier, France

    PRINCIPAL INVESTIGATOR

  • Alain Lacampagne, PHD

    INSERM, France

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 17, 2009

Study Start

April 1, 2010

Study Completion

November 1, 2011

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

FR(1)