NCT04349566

Completed

Fast Troponin as a Biomarker to Assess Exercise-induced Musc...

Mads Peter Godtfeldt Stemmerik Source

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Other study identifiers

Sponsor study identifier

FAST TROPONIN

Study Type

observational

Actual enrollment (reported)

36

Locations

1 country

Sites

1

Timeline

Study Start

June 1, 2020

Actual (reported)

Primary Completion

December 20, 2021

Actual (reported)

Study Completion

December 20, 2021

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 36 participants
Study completion date: December 20, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 14, 2020
Actual (reported)
First Posted
April 16, 2020
Actual (reported)
Study Start
June 1, 2020
Actual (reported)
Primary Completion
December 20, 2021
Actual (reported)
Study Completion
December 20, 2021
Actual (reported)

Last Updated: October 27, 2022
Status Verified: October 2022
Last Update Submitted: October 26, 2022

Conditions

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

Outcome Measures

Primary Outcomes (1)

Change in biomarkers
Change in Fast and slow Troponin I after muscle damage
24 hours

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-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.

You may qualify if:

The ability to cycle

Sponsors & Collaborators

Mads Peter Godtfeldt Stemmerik
Otherlead
Edgewise Therapeutics, Inc.
Industrycollaborator

Study Sites (1)

Neuromuscular Research Unit, 3342

Copenhagen, DK-2100, Denmark

MeSH Terms

Conditions

Muscular Dystrophy, DuchenneGlycogen Storage Disease Type VLimb-girdle muscular dystrophy type 2A

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGlycogen Storage DiseaseCarbohydrate Metabolism, Inborn Errors

Enrollment

36 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: MD

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 16, 2020

Study Start

June 1, 2020

Actual (reported)

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Not ApplicableCompleted

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Phase 2Completed

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Completed

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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.)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Metabolism, Inborn Errors

Metabolic Diseases

Nutritional and Metabolic Diseases

Primary Completion

December 20, 2021

Actual (reported)

Study Completion

December 20, 2021

Actual (reported)

Last Updated

October 27, 2022

Record last verified: 2022-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04349566
Data provider: ClinicalTrials.gov
Source updated: 2022-10-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:21 UTC

Locations

DK(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations