Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

European Sleep Apnea and Sudden CArdiac Death ProjEct (ESCAPE-SCD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02506166
Recruitment Status : Not yet recruiting
First Posted : July 23, 2015
Last Update Posted : July 23, 2015
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
doc. MUDr. Miloš Táborský, CSc., FESC, MBA, University Hospital Olomouc

Brief 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?

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 18 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Milos Taborsky, Prof., MD, PhD, FESC +420 58 588 3201 milos.taborsky@fnol.cz
Contact: Tomas Kara, Assoc. Prof., MD, PhD +420 58 588 3201 kara.tomas@mayo.edu

Sponsors and Collaborators
University Hospital Olomouc
Mayo Clinic
Investigators
Layout table for investigator information
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

Publications:
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.

Layout table for additonal information
Responsible Party: doc. MUDr. Miloš Táborský, CSc., FESC, MBA, Chair, Department of Cardiology, University Hospital Olomouc, University Hospital Olomouc
ClinicalTrials.gov Identifier: NCT02506166     History of Changes
Other Study ID Numbers: 44/15 ESCAPE - SCD
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by doc. MUDr. Miloš Táborský, CSc., FESC, MBA, University Hospital Olomouc:
sleep apnea
sleep disordered breathing
sudden cardiac death
heart failure
ischemic cardiomyopathy
implantable cardioverter-defibrillator (ICD) therapy
cardiac resynchronization therapy (CRT)
risk stratification
positive airway pressure therapy
SERVE-HF

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Apnea
Sleep Apnea Syndromes
Cardiomyopathies
Death
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes
Heart Arrest
Death, Sudden