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

Becker Muscular Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04349566
• Other study ID #: FAST TROPONIN
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: December 20, 2021

Study information

• Verified date: October 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Becker Muscular Dystrophy
• Glycogen Storage Disease Type V
• Limb-Girdle Muscular Dystrophy Type 2
• McArdle Disease
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Locations

Country	Name	City	State
Denmark	Neuromuscular Research Unit, 3342	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Mads Peter Godtfeldt Stemmerik	Edgewise Therapeutics, Inc.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in biomarkers	Change in Fast and slow Troponin I after muscle damage	24 hours