Sleep ApneaESCAPE-SCDNCT02506166
European Sleep Apnea and Sudden CArdiac Death ProjEct
A study testing Positive Airway Pressure Therapy in people with Sleep Apnea and Sudden Cardiac Death, run by University Hospital Olomouc.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Sleep Apnea, Sudden Cardiac Death, Heart Failure
- What is being tested?
- Positive Airway Pressure Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with ICM indicated for ICD/CRT-D implant based on current ESC Guidelines for primary prevention of sudden cardiac death
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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?
Read the detailed description
Detailed Study Description
Purpose:
There is strong evidence that patients with ischemic cardiomyopathy have high cardiovascular mortality, including high risk of sudden cardiac death. Sleep apnea is frequently present in patients after myocardial infarction/with ischemic cardiomyopathy (approximately in 50% of patients).
Both central and obstructive sleep apnea are considered as independent risk factors of worsened prognosis in patients with heart failure with reduced ejection fraction (HFrEF). However, there is no evidence from randomized trials yet providing evidence that sleep apnea is an independent risk factor leading to an increase in cardiovascular mortality, including increased risk of sudden cardiac arrhythmic death in patients with ischemic cardiomyopathy. There are also no data from randomized trials assessing if treatment of sleep apnea by positive airway pressure therapy may improve cardiovascular outcomes in these patients, including reduced risk of sudden cardiac death.
Rationale:
ICD therapy decreases risk of sudden cardiac death in patients with HFrEF, including patients with ICM with left ventricular ejection fraction of <35%. Current ESC Guidelines for implantable cardioverter defibrillator (ICD) therapy for primary prevention of sudden cardiac death in patients with ischemic cardiomyopathy have high sensitivity and high positive predictive value. A limitation of current guidelines is low specificity and low negative predictive value. In real clinical practice, it means that less than 1/3 of patients with heart failure with reduced ejection fraction who get the ICD device for an indication of primary prevention of sudden cardiac death will receive appropriate ICD discharge. The remaining 2/3 of patients have no benefit from ICD implantation, and are exposed to risks of complications resulting from ICD implant, such as inappropriate ICD discharges, lead dislocation, or even life-threatening complications such as infectious endocarditis or myocardial perforation.
Therefore, improvements of stratification criteria allowing better identification of those patients with ICM that will have real benefit from ICD therapy, and improvement of long-term outcomes and cost-benefit of ICD therapy, represent one of the major challenges of modern cardiology.
Previous studies show that sleep apnea increases the risk of sudden cardiac death in the population. In other words, sleep apnea represents a treatable condition which is also a potential risk factor of sudden cardiac death. Some previously non-randomized studies showed that in patients with HFrEF, both obstructive and central sleep apnea may increase risk of sudden cardiac arrhythmic death. Contrary to these observations, recently released preliminary data from the SERVE-HF trial indicate that in patients with HFrEF, treatment of central sleep apnea by adaptive servo-ventilation therapy increases cardiovascular mortality, and responsible mechanisms might include increased risk of sudden cardiac death.
There are several pathophysiological mechanisms by which both obstructive and central sleep apnea may increase risk of sudden cardiac arrhythmic death in ICM patients. Considering the high prevalence of sleep disordered breathing in patients with ICM, sleep apnea represents a modifiable risk factor, where proper treatment may decrease risk of sudden cardiac death and/or improve cardiovascular outcomes in ICM patients. However, randomized studies specifically addressing the role of sleep apnea in risk of sudden cardiac arrhythmic death in ICM patients are needed to clarify the existing controversy and provide information highly needed for routine clinical practice.
Objective
The ESCAPE - SCD Study will address following specific study questions:
- Is obstructive sleep apnea and/or central sleep apnea an independent risk factor of sudden cardiac death (SCD) in patients with ICM indicated for ICD/CRT-D implant based on current 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?
Study Design:
Prospective, randomized, international multi-centric study.
Study Population:
900 patients with ICM indicated for ICD/CRT-D implant based on 2012 and 2013 ESC Guidelines for primary prevention of sudden cardiac death (see Section: "References") will be enrolled in this study. A sleep study will be performed in each of the subjects and based on results patients will be divided to 4 Groups.
- No or Mild Sleep Apnea Group (Group 1): Patients with no or mild sleep apnea will continue with standard therapy (ICD/CRT-D implant + maximal medical therapy).
Patients with moderate and severe predominant obstructive sleep apnea (AHI >15) will be randomized in 1:1 ratio to
- Obstructive Sleep Apnea - Control Group (Group 2) - patients with predominant obstructive sleep apnea that will receive standard therapy (ICD/CRT-D implant + maximal medical therapy), but no PAP therapy for sleep apnea treatment and to
- Obstructive Sleep Apnea - Active Group (Group 3) - patients with predominant obstructive sleep apnea that will receive standard therapy (ICD/CRT-D implant + maximal medical therapy), plus, as intervention, sleep apnea treatment by using PAP therapy.
- Central Sleep Apnea Group (Group 4) - patients with predominant central sleep apnea that 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 and will be followed.
Distribution of Patient Population among Study Group:
Based on data derived from our pilot study, approximately 60% of patients with ischemic cardiomyopathy indicated for ICD/CRT-D implant for primary prevention of sudden cardiac death have undiagnosed moderate or severe sleep apnea. Therefore, we expect the following distribution of patients among patients' groups: Group 1: n=400 patients; Group 2: n=200 patients; Group 3: n=200, Group 4: n=100 patients.
Primary and secondary goals:
Primary goal:
- 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
Secondary goals:
- Assessment of the effect of sleep apnea and OSA treatment on cardiovascular mortality and morbidity by assessing MACE (Major Adverse Cardiovascular Events)
- Assessment of incidence of complications resulting from ICD/CRT-D therapy among study 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.
- Assessment of sleep apnea treatment on systolic and diastolic functions and neurohumoral profile
- Assessment of prevalence of sleep apnea and its severity among study population
Eligibility
Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Technologies used for sleep apnea treatment It is planned to use the Airsense 10 Autoset (AutoCPAP) and Aircurve 10 CS Pacewave (AutoASV) RESMED devices for sleep disordered breathing treatment in Group 3 with sleep apnea treatment telemonitoring option.
Technologies used for detection of life-threatening ventricular arrhythmias:
Most advanced ICD/CRT-D technologies allowing telemonitoring detection of cardiac arrhythmias will be used in as many patients as possible who are enrolled into this study.
Study Timeline:
- Study initiation: January 2016
- Patient enrollment: March 2016 - December 2017
- Average follow-up: 36 months
- End of follow-up: December 2019
- Data analysis: January-December 2021
- Estimated publication of final results: 2022
Study Co-Principal Investigators (listed alphabetically): Assoc. Prof. Tomas Kara, MD, PhD, Prof. Virend K. Somers, MD, DPhil., Prof. Milos Taborsky, MD, PhD
Study sponsors:
Investigator Initiated Trial.
Contacts and locations:
Coordinating center:
Department of Cardiovascular Diseases University Hospital Olomouc I.P. Pavlova 6 779 00 Olomouc, Czech Republic Phone.: +420 58 588 3201 Fax: +420 58 588 2500
Summary:
This would be the very first randomized study assessing the effect of predominantly obstructive sleep apnea treatment on risk of sudden cardiac death and cardiovascular outcomes in patients with ischemic cardiomyopathy. The study will also address important questions related to improvement of selection of patients that may benefit from ICD/CRT-D therapy. We have solid evidence from our pilot data that addition of sleep disordered breathing screening and treatment may improve the selection of patients with ischemic cardiomyopathy that can benefit from ICD therapy, including improvement their long-term outcomes. Use of technologies for telemonitoring of efficiency of sleep disordered breathing treatment and occurrence of cardiac arrhythmias will increase the scientific strength of the study and will explore the benefit of use of telemonitoring technologies in daily clinical practice.
- Being tested
- Positive Airway Pressure Therapy
- Keywords
- 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
- Medical subject headings
- Sleep Apnea Syndromes, Death, Sudden, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway Pressure TherapyDevice
Positive Airway Pressure Therapy will be used in Group 3 for treatment of predominant obstructive sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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
Measured: 36 months
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.
Measured: 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
Correlation between apnea hypopnea index and incidence of appropriate ICD/CRT-D discharges will be compared among groups
Measured: 36 months
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
Measured: 36 months
Assessment of prevalence of sleep apnea among study population
Apnea-hypopnea index will be used to determine the severity of sleep apnea
Measured: Time of enrollenment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, doc. MUDr. Miloš Táborský, CSc., FESC, MBA, University Hospital Olomouc
- Investigators
- Tomas Kara, Assoc. Prof., MD, PhD, Principal investigator, University Hospital OlomoucVirend K Somers, Prof., MD, DPhil, Principal investigator, Mayo ClinicMilos Taborsky, Prof., MD, PhD, FESC, Principal investigator, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506166
- Sponsor's protocol ID
- 44/15 ESCAPE - SCD
- Acronym
- ESCAPE-SCD
- Status last verified
- Jul 2015
- First submitted
- 20 Jul 2015
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22611136Brignole 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.
PubMed 23801822
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Sleep Apnea and Sudden CArdiac Death ProjEct
- ClinicalTrials.gov ID
- NCT02506166
- Acronym / sponsor ID
- ESCAPE-SCD / 44/15 ESCAPE - SCD
- Keywords
- sleep apnea, sleep disordered breathing, sudden cardiac death, heart failure, ischemic cardiomyopathy, implantable cardioverter-defibrillator (ICD) therapy, cardiac resynchronization therapy (CRT), risk stratification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- Jan 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Detailed Study Description
Purpose:
There is strong evidence that patients with ischemic cardiomyopathy have high cardiovascular mortality, including high risk of sudden cardiac death. Sleep apnea is frequently present in patients after myocardial infarction/with ischemic cardiomyopathy (approximately in 50% of patients).
Both central and obstructive sleep apnea are considered as independent risk factors of worsened prognosis in patients with heart failure with reduced ejection fraction (HFrEF). However, there is no evidence from randomized trials yet providing evidence that sleep apnea is an independent risk factor leading to an increase in cardiovascular mortality, including increased risk of sudden cardiac arrhythmic death in patients with ischemic cardiomyopathy. There are also no data from randomized trials assessing if treatment of sleep apnea by positive airway pressure therapy may improve cardiovascular outcomes in these patients, including reduced risk of sudden cardiac death.
Rationale:
ICD therapy decreases risk of sudden cardiac death in patients with HFrEF, including patients with ICM with left ventricular ejection fraction of <35%. Current ESC Guidelines for implantable cardioverter defibrillator (ICD) therapy for primary prevention of sudden cardiac death in patients with ischemic cardiomyopathy have high sensitivity and high positive predictive value. A limitation of current guidelines is low specificity and low negative predictive value. In real clinical practice, it means that less than 1/3 of patients with heart failure with reduced ejection fraction who get the ICD device for an indication of primary prevention of sudden cardiac death will receive appropriate ICD discharge. The remaining 2/3 of patients have no benefit from ICD implantation, and are exposed to risks of complications resulting from ICD implant, such as inappropriate ICD discharges, lead dislocation, or even life-threatening complications such as infectious endocarditis or myocardial perforation.
Therefore, improvements of stratification criteria allowing better identification of those patients with ICM that will have real benefit from ICD therapy, and improvement of long-term outcomes and cost-benefit of ICD therapy, represent one of the major challenges of modern cardiology.
Previous studies show that sleep apnea increases the risk of sudden cardiac death in the population. In other words, sleep apnea represents a treatable condition which is also a potential risk factor of sudden cardiac death. Some previously non-randomized studies showed that in patients with HFrEF, both obstructive and central sleep apnea may increase risk of sudden cardiac arrhythmic death. Contrary to these observations, recently released preliminary data from the SERVE-HF trial indicate that in patients with HFrEF, treatment of central sleep apnea by adaptive servo-ventilation therapy increases cardiovascular mortality, and responsible mechanisms might include increased risk of sudden cardiac death.
There are several pathophysiological mechanisms by which both obstructive and central sleep apnea may increase risk of sudden cardiac arrhythmic death in ICM patients. Considering the high prevalence of sleep disordered breathing in patients with ICM, sleep apnea represents a modifiable risk factor, where proper treatment may decrease risk of sudden cardiac death and/or improve cardiovascular outcomes in ICM patients. However, randomized studies specifically addressing the role of sleep apnea in risk of sudden cardiac arrhythmic death in ICM patients are needed to clarify the existing controversy and provide information highly needed for routine clinical practice.
Objective
The ESCAPE - SCD Study will address following specific study questions:
- Is obstructive sleep apnea and/or central sleep apnea an independent risk factor of sudden cardiac death (SCD) in patients with ICM indicated for ICD/CRT-D implant based on current 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?
Study Design:
Prospective, randomized, international multi-centric study.
Study Population:
900 patients with ICM indicated for ICD/CRT-D implant based on 2012 and 2013 ESC Guidelines for primary prevention of sudden cardiac death (see Section: "References") will be enrolled in this study. A sleep study will be performed in each of the subjects and based on results patients will be divided to 4 Groups.
- No or Mild Sleep Apnea Group (Group 1): Patients with no or mild sleep apnea will continue with standard therapy (ICD/CRT-D implant + maximal medical therapy).
Patients with moderate and severe predominant obstructive sleep apnea (AHI >15) will be randomized in 1:1 ratio to
- Obstructive Sleep Apnea - Control Group (Group 2) - patients with predominant obstructive sleep apnea that will receive standard therapy (ICD/CRT-D implant + maximal medical therapy), but no PAP therapy for sleep apnea treatment and to
- Obstructive Sleep Apnea - Active Group (Group 3) - patients with predominant obstructive sleep apnea that will receive standard therapy (ICD/CRT-D implant + maximal medical therapy), plus, as intervention, sleep apnea treatment by using PAP therapy.
- Central Sleep Apnea Group (Group 4) - patients with predominant central sleep apnea that 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 and will be followed.
Distribution of Patient Population among Study Group:
Based on data derived from our pilot study, approximately 60% of patients with ischemic cardiomyopathy indicated for ICD/CRT-D implant for primary prevention of sudden cardiac death have undiagnosed moderate or severe sleep apnea. Therefore, we expect the following distribution of patients among patients' groups: Group 1: n=400 patients; Group 2: n=200 patients; Group 3: n=200, Group 4: n=100 patients.
Primary and secondary goals:
Primary goal:
- 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
Secondary goals:
- Assessment of the effect of sleep apnea and OSA treatment on cardiovascular mortality and morbidity by assessing MACE (Major Adverse Cardiovascular Events)
- Assessment of incidence of complications resulting from ICD/CRT-D therapy among study 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.
- Assessment of sleep apnea treatment on systolic and diastolic functions and neurohumoral profile
- Assessment of prevalence of sleep apnea and its severity among study population
Eligibility
Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Technologies used for sleep apnea treatment It is planned to use the Airsense 10 Autoset (AutoCPAP) and Aircurve 10 CS Pacewave (AutoASV) RESMED devices for sleep disordered breathing treatment in Group 3 with sleep apnea treatment telemonitoring option.
Technologies used for detection of life-threatening ventricular arrhythmias:
Most advanced ICD/CRT-D technologies allowing telemonitoring detection of cardiac arrhythmias will be used in as many patients as possible who are enrolled into this study.
Study Timeline:
- Study initiation: January 2016
- Patient enrollment: March 2016 - December 2017
- Average follow-up: 36 months
- End of follow-up: December 2019
- Data analysis: January-December 2021
- Estimated publication of final results: 2022
Study Co-Principal Investigators (listed alphabetically): Assoc. Prof. Tomas Kara, MD, PhD, Prof. Virend K. Somers, MD, DPhil., Prof. Milos Taborsky, MD, PhD
Study sponsors:
Investigator Initiated Trial.
Contacts and locations:
Coordinating center:
Department of Cardiovascular Diseases University Hospital Olomouc I.P. Pavlova 6 779 00 Olomouc, Czech Republic Phone.: +420 58 588 3201 Fax: +420 58 588 2500
Summary:
This would be the very first randomized study assessing the effect of predominantly obstructive sleep apnea treatment on risk of sudden cardiac death and cardiovascular outcomes in patients with ischemic cardiomyopathy. The study will also address important questions related to improvement of selection of patients that may benefit from ICD/CRT-D therapy. We have solid evidence from our pilot data that addition of sleep disordered breathing screening and treatment may improve the selection of patients with ischemic cardiomyopathy that can benefit from ICD therapy, including improvement their long-term outcomes. Use of technologies for telemonitoring of efficiency of sleep disordered breathing treatment and occurrence of cardiac arrhythmias will increase the scientific strength of the study and will explore the benefit of use of telemonitoring technologies in daily clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Positive Airway Pressure TherapyICM 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. |
| 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. |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with ICM indicated for ICD/CRT-D implant based on current ESC Guidelines for primary prevention of sudden cardiac death
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Airway Pressure TherapyPositive Airway Pressure Therapy will be used in Group 3 for treatment of predominant obstructive sleep apnea | Device | Obstructive Sleep Apnea - Active Group (Group 3) |
Primary outcome
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
5 secondary outcomes
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
Assessment of incidence of complications resulting from ICD/CRT-D therapy among study groups
Time frame: 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
Time frame: 36 months
Assessment of effect of sleep apnea treatment on systolic and diastolic functions and neurohumoral profile
Time frame: 36 months
Assessment of prevalence of sleep apnea among study population
Time frame: Time of enrollenment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Background: PubMed 22611136McMurray 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.
- Background: PubMed 23801822Brignole 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomas Kara, Assoc. Prof., MD, PhD principal investigator
University Hospital Olomouc
Virend K Somers, Prof., MD, DPhil principal investigator
Mayo Clinic
Milos Taborsky, Prof., MD, PhD, FESC principal investigator
University Hospital Olomouc
Questions about this trial
What is this clinical trial studying?
A study testing Positive Airway Pressure Therapy in people with Sleep Apnea and Sudden Cardiac Death, run by University Hospital Olomouc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Milos Taborsky, Prof., MD, PhD, FESC (+420 58 588 3201, milos.taborsky@fnol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506166, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.