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

NCT ID: NCT04349566

Last Updated: 2022-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-12-20

Brief Summary

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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

Detailed Description

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Conditions

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Becker Muscular Dystrophy McArdle Disease Limb-Girdle Muscular Dystrophy Type 2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Edgewise Therapeutics, Inc.

INDUSTRY

Sponsor Role collaborator

Mads Peter Godtfeldt Stemmerik

OTHER

Sponsor Role lead

Responsible Party

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Mads Peter Godtfeldt Stemmerik

MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Neuromuscular Research Unit, 3342

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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FAST TROPONIN

Identifier Type: -

Identifier Source: org_study_id

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