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TerminatedNCT01014611CalcicardUpdated Oct 7, 2026

Impact of Heart Failure on Calcium Homeostasis and Mitochondrial Function in Human Skeletal Muscle

An observational study in Heart Failure, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Terminated at 1 site in France. Open to male participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Observational

Why this study was terminated
Difficulties of recruitement
Updated Oct 7, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3
Ages
35 Years to 65 Years
Sex
Male
01

Study 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.

Read the detailed description

Heart failure (HF) is associated with a skeletal muscle dysfunction, characterized by an increased fatigue that does not correlate with impaired myocardial function and physical inactivity that is commonly associated with HF. We identified in skeletal muscle of HF rats, a dysfunction of type 1 ryanodine receptors (RyR1) similar to that observed on the cardiac channel (RyR2), due to an hyperphosphorylation of the RyR and a dissociation of the regulatory protein FKBP12. This dysfunction, in addition to mitochondrial impairment, contributes in this animal model to the reduced exercise capacity observed during HF. Our goal is to analyse the impact of HF on calcium homeostasis, mitochondrial function and oxidative stress in human skeletal muscle. This project, performed on muscle biopsies, will also allow us to correlate calcium homeostasis and mitochondrial function (before and after exercise training) to circulating factors (cytokines, catecholamines) susceptible to trigger this muscle dysfunction.

This project addresses two straightforward questions about physiopathological mechanisms involved in skeletal muscle dysfunction during HF. To this aim we have built locally a network of laboratories and clinical services, used to work together, composed of two services of the University Hospital of Montpellier (Dept. of Cardiology and Dept of Clinical Physiology), an Inserm unit (U637, team 2) all interfaced by an another Inserm facility: the Clinical Investigation Center (CIC) of Montpellier. In this project we will focus on the dilated post-ischemic cardiomyopathy and compare two groups of patients under similar treatments studied at different stages of HF defined by the NYHA. The first patients (class II of NYHA) with a fraction of ejection between 40% and 30 % will be compared with patients (class III) with an ejection fraction lower than 30% (12 males, 35-65 years old per HF). 24 voluntary healthy sedentary individuals carefully selected for similar level of activity as for patients will be matched to the HF groups. All individuals will undergo cardiovascular explorations (ECG and echocardiography, blood test) at the inclusion. They will perform an exercise testing to evaluate their exercise capacity. A muscle biopsy will be performed 4 days after the exercise testing to assess the mitochondrial function and the Ca2+ homeostasis. After a rest period of 5 days, HF patients will perform a resistance-training program (3 times per week for 10 weeks). A 2nd cardiovascular explorations, exercise testing and muscle biopsy will then be performed to evaluate the beneficial effect of training. Mitochondrial function will be measured by oxygraphy and ATP production. Ca2+ homeostasis will be evaluated by confocal microscopy by recording spontaneous Ca2+ release events (i.e. RyR activity). Mitochondrial and RyR biochemical analysis will complete these functional studies as well as circulating factors (cytokines, catecholamine) and their associated receptors.

This project will allow us to characterize the behaviour of RyR in relation with mitochondrial function in human skeletal muscle during HF and identify beneficial effects of exercise training routinely proposed to HF patients. The analysis of circulating factors will allow us to establish a relation of cause and effect between myocardial dysfunction and muscle dysfunction. This project could thus open important perspectives in therapeutic. Compounds analogues to JTV-519, acting in stabilizing RyR channels, could be prescribed as a potent medication for HF. This project could thus be determinant in the comprehension of the regulation of Ca2+ and energetic metabolism in human skeletal muscle which could be an appropriate model to evaluate the effects of new pharmacological agents.

02

Conditions studied

  • Heart Failure

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Keywords

  • Heart failure
  • Skeletal muscle
  • Calcium
  • Ryanodine receptor
  • Mitochondria
  • Exercise training
  • Muscle biopsy
  • Healthy volunteers
03

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's enrollment of 3 is below the median of 200 across 1,719 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 376 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • BMI \< 30

Exclusion criteria

Exclusion Criteria:

  • Contra-indication to exercise testing performance and muscle biopsy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3 participants (actual)

Groups and cohorts

  • 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

06

What researchers measure

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

    Time frame: Baseline measurement

Secondary outcomes

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

    Time frame: Baseline measurement

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

    Time frame: 10 weeks

07

Study locations

1 site
  • Centre Hospitalier Régional Universitaire
    Montpellier, 34295, France
08

Timeline

1 registry update since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2010, a primary completion of Nov 2011 and a completion of Nov 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2009
First posted
Nov 17, 2009
Start
Apr 2010
Primary completionActual
Nov 2011
CompletionActual
Nov 2011
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT01014611
Collaborators
Ministry of Health, France, National Cancer Institute, France, Institut de Recherches Internationales Servier
Responsible party
Sponsor
First posted
Nov 17, 2009
Start date
Apr 2010
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Oct 7, 2026

Study contacts

Florence Galtier, MD
principal investigator · CHRU de Montpellier, France
Alain Lacampagne, PHD
study director · INSERM, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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