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Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04349566
Recruitment Status : Enrolling by invitation
First Posted : April 16, 2020
Last Update Posted : December 20, 2021
Sponsor:
Collaborator:
Edgewise Therapeutics, Inc.
Information provided by (Responsible Party):
Mads Peter Godtfeldt Stemmerik, Rigshospitalet, Denmark

Brief Summary:
The purpose of the study is to explore the biomarker Fast Troponins response to exercise in patients with Becker muscular dystrophy, Limb-girdle muscular dystrophy and McArdle disease

Condition or disease
Becker Muscular Dystrophy McArdle Disease Limb-Girdle Muscular Dystrophy Type 2

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022





Primary Outcome Measures :
  1. Change in biomarkers [ Time Frame: 24 hours ]
    Change in Fast and slow Troponin I after muscle damage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with McArdle disease and patients with two sub-typesof Limb-girdle and Becker muscular dystrophies will be included as well as healthy controls.
Criteria

Inclusion Criteria:

  • The ability to cycle
  • No concurrent medical condition that could interfere with interpretation of the results
  • Molecular diagnosis of the specific condition in specified patient groups or healthy control
  • No active muscle injury on the test day (caused by recent exercise, seizures, trauma, etc.)

Exclusion Criteria:

  • Competing conditions at risk of compromising the results of the study
  • Cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise
  • Veins that are too difficult to puncture for blood sampling, evaluated by the investigator
  • Severe muscle weakness, that prevents the subject completing the exercise test, evaluated by the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349566


Locations
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Denmark
Neuromuscular Research Unit, 3342
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Mads Peter Godtfeldt Stemmerik
Edgewise Therapeutics, Inc.
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Responsible Party: Mads Peter Godtfeldt Stemmerik, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04349566    
Other Study ID Numbers: FAST TROPONIN
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: December 20, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Dystrophies, Limb-Girdle
Glycogen Storage Disease Type V
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Glycogen Storage Disease
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases