NCT02506166

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?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

5.9 years

First QC Date

July 20, 2015

Last Update Submit

July 22, 2015

Conditions

Sleep ApneaSudden Cardiac DeathHeart FailureIschemic Cardiomyopathy

Keywords

sleep apneasleep disordered breathingsudden cardiac deathheart failureischemic cardiomyopathyimplantable cardioverter-defibrillator (ICD) therapycardiac resynchronization therapy (CRT)risk stratificationpositive airway pressure therapySERVE-HF

Outcome Measures

Primary Outcomes (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

    36 months

Secondary Outcomes (5)

  • 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)

    36 months

  • Assessment of incidence of complications resulting from ICD/CRT-D therapy among study groups

    36 months

  • 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

    36 months

  • Assessment of effect of sleep apnea treatment on systolic and diastolic functions and neurohumoral profile

    36 months

  • Assessment of prevalence of sleep apnea among study population

    Time of enrollenment

Study Arms (4)

No or Mild Sleep Apnea Group (Group 1)

NO INTERVENTION

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")

Obstructive Sleep Apnea - Control Group (Group 2)

NO INTERVENTION

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.

Obstructive Sleep Apnea - Active Group (Group 3)

ACTIVE COMPARATOR

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

Central Sleep Apnea Group (Group 4)

NO INTERVENTION

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.

Interventions

Positive Airway Pressure TherapyDEVICE

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

Obstructive Sleep Apnea - Active Group (Group 3)

Eligibility Criteria

Age18 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with ICM indicated for ICD/CRT-D implant based on current ESC Guidelines for primary prevention of sudden cardiac death

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik 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. No abstract available.

    PMID: 22611136BACKGROUND

  • 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, Bansch 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. No abstract available.

    PMID: 23801822BACKGROUND

MeSH Terms

Conditions

Sleep Apnea SyndromesDeath, Sudden, CardiacHeart Failure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHeart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Milos Taborsky, Prof., MD, PhD, FESC

CONTACT

+420 58 588 3201milos.taborsky@fnol.cz

Tomas Kara, Assoc. Prof., MD, PhD

CONTACT

+420 58 588 3201kara.tomas@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Cardiology, University Hospital Olomouc

Study Record Dates

First Submitted

July 20, 2015

First Posted

July 23, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

July 23, 2015

Record last verified: 2015-07