Heart Failure Clinical Trial
— ESCAPE-SCDOfficial title:
European Sleep Apnea and Sudden CArdiac Death ProjEct
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?
Status | Not yet recruiting |
Enrollment | 900 |
Est. completion date | December 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 18 Years |
Eligibility |
Inclusion Criteria: Patients with ICM indicated for ICD/CRT-D implant based on current ESC Guidelines for primary prevention of sudden cardiac death Exclusion Criteria: - Previously diagnosed sleep apnea CPAP, BiPAP or ASV treatment - Patients with previously implanted ICD/CRT-D device indicated for device replacement - Uncontrolled hypertension - Severe valvular heart disease/dysfunction with exception of ischemic and functional mitral regurgitation - Acute coronary syndrome or acute cardiac decompensation in 4 weeks before ICD/CRT-D implant - Expected indication of heart transplant in period of 12 months or less after ICD/CRT-D implant - Expected cardiac surgery or percutaneous coronary intervention in period of 12 months or less after ICD/CRT-D implant - Severe pulmonary diseases - Rejection of participation in the study - Pregnancy - Age of 80 years and higher in time of ICD/CRT-D implant |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital Olomouc | Mayo Clinic |
Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG), Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers, Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bänsch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24. — View Citation
McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Böhm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Køber L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Rønnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. Erratum in: Eur Heart J. 2013 Jan;34(2):158. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 36 months | No | |
Secondary | 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) | 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 | 36 months | Yes |
Secondary | Assessment of incidence of complications resulting from ICD/CRT-D therapy among study groups | Incidence of inappropriate ICD discharges, lead dislocation, device malfunction, infectious endocarditis, myocardial perforation will be particularly compared among groups. | 36 months | No |
Secondary | 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 | Correlation between apnea hypopnea index and incidence of appropriate ICD/CRT-D discharges will be compared among groups | 36 months | No |
Secondary | Assessment of effect of sleep apnea treatment on systolic and diastolic functions and neurohumoral profile | Ejection fraction will be used to determine systolic function. Standard criteria for diastolic dysfunction measurement will be used | 36 months | No |
Secondary | Assessment of prevalence of sleep apnea among study population | Apnea-hypopnea index will be used to determine the severity of sleep apnea | Time of enrollenment | No |
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