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Heart Rate Variability in Individuals With Duchenne Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT04740554
Recruitment Status : Completed
First Posted : February 5, 2021
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Talita Dias da Silva, University of Sao Paulo

Brief Summary:

A cross-sectional study was carried out, in which 40 boys, aged 11 to 18 years, were evaluated. The recruitment of groups was carried out at the neuromuscular disease outpatient clinic of the Federal University of São Paulo (UNIFESP). The recruited individuals were divided into 4 groups, namely: DMD that used deflazacort (DMD-D); DMD that used Prednisone/Prednisolone (DMD-P); DMD Control with no corticoid use (DMD-C) and Controls with typical development (CTD). The protocol was applied during the evaluation that was carried out at outpatient follow-up visits.

To assess the functionality of each patient, the Vignos scales were used to characterize the sample and the Motor Function Measure (MFM) for association with HRV indices.

All heart rate records were performed using a cardiofrequencymeter (V800, Polar). After placing the brace and monitor, the individuals were placed in the supine position and remained at rest spontaneously breathing for 25 minutes. For HRV analysis, indexes obtained by linear methods, in the domain of time and frequency, and non-linear methods were used.


Condition or disease Intervention/treatment
Duchenne Muscular Dystrophy Behavioral: Duchenne Muscular Dystrophy group with Deflazacort Behavioral: Duchenne Muscular Dystrophy group with Prednisone/Predisolone Behavioral: Duchenne Muscular Dystrophy group without Corticosteroids therapy Behavioral: Control Group Typically Developing

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Characterization of Heart Rate Variability in Individuals With Duchenne Muscular Dystrophy - Influence of Corticosteroids and Betablockers
Actual Study Start Date : March 1, 2013
Actual Primary Completion Date : September 1, 2014
Actual Study Completion Date : February 1, 2015


Group/Cohort Intervention/treatment
Duchenne Muscular Dystrophy group with Deflazacort
Individuals Duchenne Muscular Dystrophy, with age 11 to 18 years which make use of deflazacort.
Behavioral: Duchenne Muscular Dystrophy group with Deflazacort
Subjects with duchenne muscular dystrophy undergoing drug therapy with Deflazacort

Duchenne Muscular Dystrophy group with Prednisone/Predisolone
Individuals Duchenne Muscular Dystrophy, with age 11 to 18 years which make use of Prednisone/Predinisolone.
Behavioral: Duchenne Muscular Dystrophy group with Prednisone/Predisolone
Subjects with duchenne muscular dystrophy undergoing drug therapy with Prednisona/Predinisolone

Duchenne Muscular Dystrophy group without Corticosteroids therapy
Individuals Duchenne Muscular Dystrophy, with age 11 to 18 years which don't use of corticosteroids.
Behavioral: Duchenne Muscular Dystrophy group without Corticosteroids therapy
Control group with duchenne muscular dystrophy without the use of corticosteroid drug therapy.

Control Group Typically Developing
Individuals with typical development age 11 to 18 years which don't use of corticosteroids.
Behavioral: Control Group Typically Developing
Control group with tipical development.




Primary Outcome Measures :
  1. Heart Rate Variability in adolescents with Duchenne Muscular Dystrophy undergoing therapy with corticosteroids [ Time Frame: One day ]
    Heart rate variability indices at rest in adolescents with duchenne muscular dystrophy will be analyzed, which will be divided into the following groups: Under the use of Deflazacort, Predinisone / Predinisolone and without the use of corticosteroids, in addition to the analysis of a control group with typical development.



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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   It is a disease that affects only male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
30 boys with Duchenne Muscular Dystrophy and 10 typically developing boys aged 11 to 18 years.
Criteria

Inclusion Criteria:

  • Individuals diagnosed with DMD confirmed by molecular method and / or by protein expression of skeletal muscle.
  • Individuals undergoing clinical follow-up at the outpatient clinic for neuromuscular diseases at the Federal University of São Paulo (UNIFESP)
  • Individuals who had authorization from their parents or guardians to participate in the study

Exclusion Criteria:

  • Patients with cardiac arrhythmias.
  • Patients with atrioventricular block.
  • Patients with congenital anomalies such as congenital heart defects, pulmonary deformity.
  • Patients using drugs that interfere with ANS, such as antiarrhythmic agents and drugs for the treatment of diabetes mellitus, such as insulin.

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): NCT04740554


Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Talita D da Silva, Ph.D. Universidade Federal de São Paulo
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Responsible Party: Talita Dias da Silva, Researcher, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04740554    
Other Study ID Numbers: 09942913.4.0000.5505
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Talita Dias da Silva, University of Sao Paulo:
Muscular Dystrophy, Duchenne
Prednisone
Deflazacort
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Prednisone
Deflazacort
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors