European Sleep Apnea and Sudden CArdiac Death ProjEct (ESCAPE-SCD)
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|ClinicalTrials.gov Identifier: NCT02506166|
Recruitment Status : Not yet recruiting
First Posted : July 23, 2015
Last Update Posted : July 23, 2015
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?
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Sudden Cardiac Death Heart Failure Ischemic Cardiomyopathy||Device: Positive Airway Pressure Therapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||European Sleep Apnea and Sudden CArdiac Death ProjEct|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
No Intervention: No or Mild Sleep Apnea Group (Group 1)
ICM patients with no or mild sleep apnea enrolled in this arm will continue with standard therapy (ICD/CRT-D implant + maximal medical therapy), but will receive no active Positive Airway Pressure (PAP) therapy for sleep apnea treatment. See Part: "Study Population" for more details.
In all ICM patients enrolled into ESCAPE-SCD Study, the ICD/CRT-D devices will be implanted based on current ESC Guidelines for primary prevention of sudden cardiac death (see Section: "References")
No Intervention: Obstructive Sleep Apnea - Control Group (Group 2)
ICM patients with predominant obstructive sleep apnea randomised to this arm will receive standard therapy (ICD/CRT-D implant + maximal medical therapy), but no PAP therapy for sleep apnea treatment. See Part: "Study Population" for more details.
Active Comparator: Obstructive Sleep Apnea - Active Group (Group 3)
ICM patients with predominant obstructive sleep apnea randomised to this arm will receive standard therapy (ICD/CRT-D implant + maximal medical therapy), plus as intervention, all patinets in this group will receive sleep apnea treatment by using PAP device. See Part: "Study Population" for more details.
Device: Positive Airway Pressure Therapy
Positive Airway Pressure Therapy will be used in Group 3 for treatment of predominant obstructive sleep apnea
No Intervention: Central Sleep Apnea Group (Group 4)
ICM patients with predominant central sleep apnea enrolled in this group will receive standard therapy (ICD/CRT-D implant + maximal medical therapy). Because the SERVE-HF Trial demonstrated a negative effect of predominantly central sleep apnea treatment on cardiovascular mortality in patients with HFrEF by using adaptive servo-ventilation therapy, patients in Group 4 will not receive any PAP therapy for treatment of sleep disordered breathing. See Part: "Study Population" for more details.
- Assessment of sleep apnea and its treatment on risk of sudden cardiac arrhythmic death by assessing the number of appropriate ICD/CRT-D discharges for each of the groups [ Time Frame: 36 months ]
- Assessment of the effect of sleep apnea and OSA treatment on cardiovascular mortality and morbidity by assessing the incidence of MACE (Major Adverse Cardiovascular Events) [ Time Frame: 36 months ]MACE will be particularly assessed as: death of any cardiovascular origin, heart transplantation, myocardial revascularization, non-fatal stroke, hospitalization for heart failure progression, hospitalization for any cardiovascular origin
- Assessment of incidence of complications resulting from ICD/CRT-D therapy among study groups [ Time Frame: 36 months ]Incidence of inappropriate ICD discharges, lead dislocation, device malfunction, infectious endocarditis, myocardial perforation will be particularly compared among groups.
- Assessment of sleep apnea as 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 [ Time Frame: 36 months ]Correlation between apnea hypopnea index and incidence of appropriate ICD/CRT-D discharges will be compared among groups
- Assessment of effect of sleep apnea treatment on systolic and diastolic functions and neurohumoral profile [ Time Frame: 36 months ]Ejection fraction will be used to determine systolic function. Standard criteria for diastolic dysfunction measurement will be used
- Assessment of prevalence of sleep apnea among study population [ Time Frame: Time of enrollenment ]Apnea-hypopnea index will be used to determine the severity of sleep apnea
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): NCT02506166
|Contact: Milos Taborsky, Prof., MD, PhD, FESC||+420 58 588 firstname.lastname@example.org|
|Contact: Tomas Kara, Assoc. Prof., MD, PhD||+420 58 588 email@example.com|
|Principal Investigator:||Tomas Kara, Assoc. Prof., MD, PhD||University Hospital Olomouc|
|Principal Investigator:||Virend K Somers, Prof., MD, DPhil||Mayo Clinic|
|Principal Investigator:||Milos Taborsky, Prof., MD, PhD, FESC||University Hospital Olomouc|