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

NCT01956721 | Terminated

• 1 other identifier: 9051
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to investigate the impact of heart failure (HF) on calcium homeostasis, mitochondrial function and oxydative stress in human skeletal muscle. The role playing by circulating factors such as cytokines and catecholamines will also be evaluated. 24 HF patients wiil be enrolled in the study: 12 male volunteers with a fraction of ejection ≥ 50% and 12 male volunteers with a fraction of ejection ≤ 35%. They will be compared to 12 sedentary healthy male volunteers, matched on age and physical activity.

Conditions

Heart Failure

Keywords

Heart Failure , Skeletal muscle,Calcium,Ryanodine Receptor, Mitochondria, Exercise training, Muscle biopsy, Healthy volunteers

Outcome Measures

Primary Outcomes (2)

• calcium homeostasis

  Cell analysis

  8 days

• mitochondrial function

  Cell analysis

  8 days

Secondary Outcomes (1)

• skeletal muscular function in two stages of heart failure

  8 days

Study Arms (3)

Patients with heart failure (FEVG ≥ 50%)

EXPERIMENTAL

Patients with heart failure (FEVG ≥ 50%)

Procedure: Exercise training,; Procedure: Muscle biopsy

Patients with heart failure (FEVG ≤ 35%),

EXPERIMENTAL

Patients with heart failure (FEVG ≤ 35%),

Procedure: Exercise training,; Procedure: Muscle biopsy

Healthy Volunteers

OTHER

Healthy Volunteers with no heart failure

Procedure: Exercise training,; Procedure: Muscle biopsy

Interventions

Exercise training, PROCEDURE

Healthy Volunteers; Patients with heart failure (FEVG ≤ 35%),; Patients with heart failure (FEVG ≥ 50%)

Muscle biopsy PROCEDURE

Healthy Volunteers; Patients with heart failure (FEVG ≤ 35%),; Patients with heart failure (FEVG ≥ 50%)

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- BMI \< 30

You may not qualify if:

• Contra-indication to exercise testing performance and muscle biopsy

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Ministry of Health, France: collaborator
• National Cancer Institute, France: collaborator
• Institut de Recherches Internationales Servier: collaborator

Study Sites (1)

physiologie clinique, hopital Arnaud de Villeneuve, 371 avenue du Doyen G;Giraud

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: October 8, 2013
• Study Start: September 18, 2013
• Primary Completion: June 21, 2016
• Study Completion: June 30, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

FR (1)