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Sudden Cardiac Death Stratification in Myotonic Dystrophy Type 1 Patients

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ClinicalTrials.gov Identifier: NCT03784586
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Vincenzo Russo, University of Campania "Luigi Vanvitelli"

Brief Summary:
The aim of the study is to evaluate if the electrophysiological study (EPS) guided therapy, including the prophylactic implantation of implantable cardioverter defibrillator (ICD), in inducible patients, is able to improve survival in comparison with conventional therapy (CONV strategy) in Myotonic Dystrophy type 1 patients with conduction disorders.

Condition or disease
Myotonic Dystrophy 1 Sudden Cardiac Death

Detailed Description:

Trial design:

This is a double-arm prospective observational study.

Patient population:

To be included in the study, DM1 patients had to have at least 18 years old, LVEF >35% on two-dimensional echocardiography, permanent pacing indication after non-invasive electrocardiographic evaluation or invasive EPS evaluation, according to the current guidelines. The following exclusion criteria were applied: electrolyte imbalance, thyroid disorders, prior cardiac surgery, prior cardiac arrest, prior spontaneous sustained ventricular arrhythmias, absuntion of antiarrhythmic drugs or medication known to affect cardiac conduction. All eligible DM1 patients underwent EPS for programmed ventricular stimulation; those in whom a sustained ventricula arrhythmia was inducible underwent subsequently ICD implantation. Non-inducible DM1 patients did not receive an ICD and underwent pacemaker implantation.

Endpoints:

The primary endpoint was all-cause mortality. Secondary end-points were sudden death (SD), death due to cardiac arrhythmias, ICD interventions and arrhythmic events in implanted patients.


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Study Type : Observational
Estimated Enrollment : 51 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Electrophysiological Study Guided ICD Strategy in Prevention of Arrhythmic Cardiac Death in Myotonic Dystrophy Type 1 Patients With Conduction System Disease
Actual Study Start Date : February 1, 2012
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020


Group/Cohort
Positive EPS - ICD
Patients with inducible sustained ventricular tachycardia or ventricular fibrillation at EPS evaluation underwent ICD implantation
Negative EPS - PMK
All non inducible patients underwent PMK implantation



Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Sudden cardiac death [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MD1 patients with permanent pacing indication and needed of sudden cardiac death screening.
Criteria

Inclusion Criteria:

  • MD1 diagnosis genetically confirmed
  • LVEF >35% on two-dimensional echocardiography
  • Permanent pacing indication according to the current guidelines

Exclusion Criteria:

  • Electrolyte imbalance
  • Thyroid disorders
  • Prior cardiac surgery
  • Prior cardiac arrest
  • Prior spontaneous sustained ventricular arrhythmias

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): NCT03784586


Contacts
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Contact: Vincenzo Russo, MD,PhD 0817064149 v.p.russo@libero.it
Contact: Andrea Antonio Papa, MD 0817065158 andreaantoniopapa@libero.it

Locations
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Italy
Vincenzo Russo Recruiting
Naples, Italy, 80136
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"

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Responsible Party: Vincenzo Russo, MD, PhD, Assistant Professor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03784586     History of Changes
Other Study ID Numbers: 01_MD1
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
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 Vincenzo Russo, University of Campania "Luigi Vanvitelli":
Arrhythmias
electrophisiological study
primary prevention

Additional relevant MeSH terms:
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Myotonic Dystrophy
Muscular Dystrophies
Myotonic Disorders
Death
Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn