RAMYD Study - Evaluation of Arrhythmic Risk in Myotonic Dystrophy

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Notable Phase: Phase 3 to Not applicablev4 Show 9 more changesShow less
    • Primary endpoints: 5 to 2
    • Trial status: Recruiting to Completed
    • Primary completion date: Dec 2009
    • Study completion date: Dec 2010
    • Interventions: Electrophysiological study (Procedure), pacemaker (PM) implant, internal cardiac defibrillator (ICD) implant, loop-recorder implant (Device) to Electrophysiological study (Procedure), pacemaker , implantable cardiac defibrillator or loop-recorder implant (Device)
    • Secondary endpoints shortened, about 32 words
    • Site details revised
    • Study arms: 0 to 1
    • Collaborators shortened, about 2 words
  2. Study Status, Study Descriptionv3
  3. Notable Primary endpoints: 2 to 5v2 Show 4 more changesShow less
    • Interventions: Electrophysiological study (Procedure), PM implant, ICD implant, loop-recorder implant (Device) to Electrophysiological study (Procedure), pacemaker (PM) implant, internal cardiac defibrillator (ICD) implant, loop-recorder implant (Device)
    • Secondary endpoints: 1 to 4
    • Study title expanded, about 8 words
    • Study description expanded, about 1 word
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
This is a prospective multicentric Italian study to evaluate the arrhythmic risk in myotonic dystrophy type 1.
Trial Details
NCT Number NCT00127582
Lead Sponsor Catholic University of the Sacred Heart
Conditions
(from sponsor)
Myotonic Dystrophy, Sudden Cardiac Death
Related terms Bradycardia, Death, Sudden, Cardiac, Myotonic Dystrophy, Tachycardia, Ventricular
Enrollment 537 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov