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

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

Study Overview

• Status: Completed
• Conditions: Becker Muscular Dystrophy; McArdle Disease; Limb-Girdle Muscular Dystrophy Type 2

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2100
    • Neuromuscular Research Unit, 3342

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in biomarkers	Change in Fast and slow Troponin I after muscle damage	24 hours

Collaborators and Investigators

• Sponsor: Mads Peter Godtfeldt Stemmerik
• Collaborators: Edgewise Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Muscular Disorders, Atrophic; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Glycogen Storage Disease; Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Dystrophies, Limb-Girdle; Glycogen Storage Disease Type V
• Other Study ID Numbers: FAST TROPONIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No