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Sudden Cardiac Death Stratification in Myotonic Dystrophy Type 1 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03784586
Recruitment Status : Active, not recruiting
First Posted : December 24, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Vincenzo Russo, University of Campania "Luigi Vanvitelli"

Tracking Information
First Submitted Date December 17, 2018
First Posted Date December 24, 2018
Last Update Posted Date April 4, 2019
Actual Study Start Date February 1, 2012
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2018)
All-cause mortality [ Time Frame: 24 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03784586 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 21, 2018)
Sudden cardiac death [ Time Frame: 24 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sudden Cardiac Death Stratification in Myotonic Dystrophy Type 1 Patients
Official Title The Electrophysiological Study Guided ICD Strategy in Prevention of Arrhythmic Cardiac Death in Myotonic Dystrophy Type 1 Patients With Conduction System Disease
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.
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population MD1 patients with permanent pacing indication and needed of sudden cardiac death screening.
Condition
  • Myotonic Dystrophy 1
  • Sudden Cardiac Death
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: December 21, 2018)
51
Original Actual Enrollment Same as current
Estimated Study Completion Date January 31, 2020
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03784586
Other Study ID Numbers 01_MD1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Vincenzo Russo, University of Campania "Luigi Vanvitelli"
Study Sponsor University of Campania "Luigi Vanvitelli"
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Campania "Luigi Vanvitelli"
Verification Date April 2019