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European Sleep Apnea and Sudden CArdiac Death ProjEct

NCT02506166 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2015-07-23

No results posted yet for this study

Summary

The objective of ESCAPE-SCD Study is assessment of the effect of sleep apnea on sudden cardiac death risk and cardiovascular outcomes in patients with ischemic cardiomyopathy. The ESCAPE - SCD Study will address following specific study questions:

* Is obstructive sleep apnea (OSA) and/or central sleep apnea (CSA) an independent risk factor of sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM) indicated for ICD/CRT-D implant based on current European Society of Cardiology (ESC) Guidelines for primary prevention of sudden cardiac death?
* Can treatment of predominant (\>50%) obstructive sleep apnea by appropriate Positive Airway Pressure (PAP) therapy decrease risk of sudden cardiac arrhythmic death in ICM patients?
* Can treatment of predominant (\>50%) obstructive sleep apnea by appropriate PAP therapy improve cardiovascular outcomes in ICM patients indicated for ICD/CRT-D implant?
* Does obstructive sleep apnea represent a novel factor that may improve risk stratification of sudden cardiac death and advance identification of those patients that will benefit from ICD/CRT-D therapy?

Conditions

Interventions

DEVICE

Positive Airway Pressure Therapy

Positive Airway Pressure Therapy will be used in Group 3 for treatment of predominant obstructive sleep apnea

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • University Hospital Olomouc

    lead OTHER

Principal Investigators

  • Tomas Kara, Assoc. Prof., MD, PhD · University Hospital Olomouc

  • Virend K Somers, Prof., MD, DPhil · Mayo Clinic

  • Milos Taborsky, Prof., MD, PhD, FESC · University Hospital Olomouc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2021-12-31
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02506166 on ClinicalTrials.gov