Sleep ApneaADVENT-HFNCT01128816
Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure
A study testing Adaptive Servo Ventilation in people with Sleep Apnea and Heart Failure, run by Toronto Rehabilitation Institute at 49 sites in 9 countries.
Trial summary
Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of hospitalizations and death. It is not known however whether treating SA reduces these risks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Heart Failure
- What is being tested?
- Adaptive Servo Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 732 participants
- Where
- 49 sitesin 9 countries
- Study dates
- May 2010to 31 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Heart Association Stage B-D Heart failure due to ischemic, idiopathic or hypertensive causes, present for at least 3 months
- Left Ventricular Ejection Fraction ≤ 45 %
- Optimal medical therapy for heart failure
- No change in active cardiac medications for 2 weeks prior to randomization, beta-blockers must be started 3 months prior to randomization
- Sleep apnea with an AHI ≥ 15. Subjects with obstructive sleep apnea must also have an Epworth Sleepiness Scale score of ≤ 10 and no or mild daytime sleepiness
- Written informed consent
Who cannot join
- Heart failure due to primary valvular heart disease
- Presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease
- Hypertrophic obstructive or restrictive or post partum cardiomyopathy
- Exercise capacity limited by class IV angina pectoris
- Acute MI, cardiac surgery, PCI, AICD, or CRT within 3 months of randomization
- Active myocarditis
Show all 14Show fewer
- Planned AICD or CRT
- Presence of a left-ventricular assist device
- Transplanted heart or expected to receive a transplanted heart within the next 6 months
- Pregnancy
- Current use of ASV or CPAP or mandibular advancement device for treatment of sleep apnea or treated with any investigational therapy during the last 4 weeks (including approved therapies being used in unapproved indications)
- A clinical history that would interfere with the objectives of this study or that would in the investigator's opinion preclude safe conclusion of the study
- Any other medical, social, or geographical factor, which would make it unlikely that the patient will comply with the study procedures (e.g. alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or history of non-compliance)
- Any contraindication to ASV therapy as detailed in the device provider manual
Trial locations and contacts
49 sites in 9 countries.
49 sites in 9 countries
Canada13 sites
Capital District Health Authority
Halifax, Nova Scotia, B3H 2E2
McMaster University Medical Centre, Hamilton Health Sciences
Hamilton, Ontario, L8S 2X2
Kingston General Hospital Sleep Disorders Laboratory/Queen's University
Kingston, Ontario, K7L 2V6
St. Mary's General Hospital
Kitchener, Ontario, N2M 1B2
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6C 2R5
Hôpital Hôtel-Dieu du CHUM
Montreal, Quebec, H2X 0C1
McGill University Health Centre, Glen Site
Montreal, Quebec, H4A 3J1
University of Ottawa-Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval
Québec, Quebec, G1V 4G5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
University Health Network/TRI/Mount Sinai
Toronto, Ontario, M5G 2C4
Vancouver General Hospital/UBC/VCHA
Vancouver, British Columbia, V5Z 1M9
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Spain9 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital San Pedro de Alcántara
Cáceres, 10003
Hospital Arnau de Vilanova
Lleida, 25198
Fundación Jiménez Diaz-CAPIO
Madrid, 28040
Hospital Universitario Marques de Valdecilla
Santander, 39008
Hospital Universitario Rio Hortega
Valladolid, 47012
Hospital Universitario Txagorritxu
Vitoria-Gasteiz, Álava, 01009
Hospital Universitario Miguel Servet
Zaragoza, 50009
France7 sites
Centre Hospitalier de Béziers
Béziers, 34500
Pole d'exploration de L' apnée du sommeil, Nouvelle Clinique Bel Air
Bordeaux, 33200
Groupe Hospitalier Ambroise Paré, AP-HP
Boulogne-Billancourt, 92100
Hôpital Antoine Béclère, AP-HP
Clamart, 92141
Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires, Centre Hospitalier Universitaire de Grenoble
Grenoble, 38043
Hôpital Bichat- Claude Bernard, AP-HP
Paris, 75018
Groupe Hospitalier Pitié-Salpêtrière Charles Foix, AP-HP
Paris, 75651
Italy5 sites
Prima Medicina-Spedali Civili
Brescia, 25123
ASST Franciacorta, Ospedale di Chiari
Chiari, BS, 25032
Istituto Auxologico Italiano - Ospedale San Luca
Milan, 20149
Istituto Scientifico di Montescano, Istituti Clinici Scientifici Maugeri (ICS Maugeri)
Pavia, 27040
Istituto Scientifico di Veruno, Istituti Clinici Scientifici Maugeri
Veruno, 28010
Japan5 sites
Saiseikai Futsukaichi Hospital
Fukuoka, 818-8516
Kyoto University Hospital
Kyoto, 606-8507
Toranomon Hospital
Tokyo, 105-8470
Juntendo University School of Medicine
Tokyo, 113-8421
Tokyo Medical University Hospital
Tokyo, 160-0023
Brazil4 sites
Pronto Socorro Cardiologico de Pernambuco
Recife, Pernambuco, CEP 50100-060
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, CEP 04012-909
CDEC Brasil - Centro de Desenvolvimento em Estudos Clínicos Brasil
São Paulo, São Paulo, CEP 04020-060
Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo, São Paulo, CEP 05403-000
United States3 sites
MetroHealth Medical Centre
Cleveland, Ohio, 44109-1998
Glacier View Research Institute, Kalispell Regional Medical Center
Kalispell, Montana, 59901
University of Arizona/Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Germany2 sites
University of Regensburg
Regensburg, Bavaria, 93053
Wissenschaftliches Institut Bethanien e.V.
Solingen, 42699
United Kingdom1 site
The Sleep Disorders Centre -Nuffield House, Guy's Hospital
London, SE1 9RT
About this study
Official title: A Multi-Centre, Randomized Study to Assess the Effects of Adaptive Servo Ventilation (ASV) on Survival and Frequency of Hospital Admissions in Patients With Heart Failure (HF) and Sleep Apnea (SA)-The ADVENT-HF Trial
Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of hospitalizations and death. It is not known however whether treating SA reduces these risks. This study is looking at whether a respiratory device known as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations and death in subjects with HF and SA. Study subjects will randomly receive either their regular medications OR their regular medications plus ASV. They will be followed for approximately 5 years and information relevant to their health will be collected and compared.
- Conditions
- Sleep Apnea, Heart Failure
- Being tested
- Adaptive Servo Ventilation
- Keywords
- obstructive sleep apnea, central sleep apnea, heart failure, congestive heart failure, adaptive servo ventilation, ASV
- Medical subject headings
- Sleep Apnea Syndromes, Heart Failure, Sleep Apnea, Obstructive, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Servo VentilationDevice
Also called BiPAP autoSV ADVANCED, ASV, Respironics
BiPAP autoSV ADVANCED device worn nightly during sleep
| Study group | Role | What they receive |
|---|---|---|
| Standard HF therapy | No intervention | Subjects will receive optimal standard therapy for heart failure conforming to national guidelines as determined by the referring cardiologist |
| Standard therapy for HF + ASV | Active comparator | Subjects will receive treatment with Adaptive Servo Ventilation in addition to optimal standard therapy for heart failure conforming to national guidelines, as determined by the referring cardiologist Receives: Device: Adaptive Servo Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to the composite outcome of death or first CV hospital admission or new onset atrial fibrillation/flutter requiring anti-coagulation but not hospitalization or delivery of an appropriate shock from an ICD not resulting in hospitalization.
The study will end once 540 primary endpoints have occurred. The maximum follow-up period for all randomized subjects is 5 years.
Measured: The expected study follow-up period is five years
Secondary outcomes (10)
Time to death from any cause
The study will end once 540 primary endpoints have occurred.
Measured: The expected study follow-up period is 5 years
Number of cardiovascular hospitalizations per year of follow-up
Measured: The minimum time of follow-up is expected to be 2 years. The maximum time of follow-up is expected to be 5 years
Number of days alive not hospitalized
The number of days the patient is hospitalized are subtracted from the total number of days in the study from randomization. This number will be compared between the 2 groups.
Measured: Time from randomization to censoring (death, primary event or end of study)
Changes in left ventricular function
Changes in LV function will be assessed by echocardiography at baseline and at 6 months post randomization
Measured: 6 months from randomization
Changes in plasma BNP levels
Changes in plasma NT-proBNP levels will be assessed at baseline and at 6 months post randomization
Measured: 6 months from randomization
Cardiac resynchronization therapy or defibrillator implantations
The average number of days from randomization to the first occurrence of CRT or defibrillator implantation will be calculated and compared between each treatment arm.
Measured: Average number of days until first cardiac resynchronization or first defibrillator implantation
Changes in 6 minute walk test distance
Changes in the 6-minute walk distance between baseline and 6 months will be compared between the 2 groups
Measured: 6 months from randomization
Percentage of patients with changes in stages of heart failure and functional class
New York Heart Association classification and AHA/ACC Stages of Heart Failure will be assessed at each visit.
Measured: Values obtained at study termination will be compared to those obtained at randomization
Changes in apnea/hypopnea index
Measured: 1 month from randomization
Changes in Quality of life assessments
Minnesota living with Heart Failure Questionnaire and Epworth Sleepiness Scale will be used. Scores will be compared between the 2 groups.
Measured: Assessments made at baseline, 1, 6, 12 and every 6 months thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startMay 2010
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Why it stopped: Philips Global Field Safety Notice for PAP Devices \& Ventilators, June 14, 2021 (June 15, 2021 censor date for trial). Patient final visits and collection of endpoints prior to censor date continued to March 31, 2022.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 732 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Philips Respironics
- Responsible party
- Principal investigator, Douglas Bradley, Toronto Rehabilitation Institute
- Investigators
- Douglas Bradley, M.D., Study chair, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128816
- Sponsor's protocol ID
- ADVENT-HF trial
- Acronym
- ADVENT-HF
- Status last verified
- Nov 2022
- First submitted
- 26 Apr 2010
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Floras JS, Logan AG, Tomlinson G, Bradley TD; ADVENT-HF Investigators. Win Ratio Analysis for Peak-Flow Adaptive Servoventilation in Treating Sleep Apnoea in Heart Failure With Reduced Ejection Fraction. Can J Cardiol. 2026 Jul;42(7):1529-1537. doi: 10.1016/j.cjca.2026.03.019. Epub 2026 Mar 20.
PubMed 41865991Horvath CM, Fisser C, Floras JS, Sossalla S, Wang S, Tomlinson G, Rankin F, Yatsu S, Ryan CM, Bradley TD, Arzt M; ADVENT-HF Investigators. Nocturnal Cardiac Arrhythmias in Heart Failure With Obstructive and Central Sleep Apnea. Chest. 2024 Dec;166(6):1546-1556. doi: 10.1016/j.chest.2024.08.003. Epub 2024 Aug 20.
PubMed 39168180Bradley TD, Logan AG, Lorenzi Filho G, Kimoff RJ, Duran Cantolla J, Arzt M, Redolfi S, Parati G, Kasai T, Dunlap ME, Delgado D, Yatsu S, Bertolami A, Pedrosa R, Tomlinson G, Marin Trigo JM, Tantucci C, Floras JS; ADVENT-HF Investigators. Adaptive servo-ventilation for sleep-disordered breathing in patients with heart failure with reduced ejection fraction (ADVENT-HF): a multicentre, multinational, parallel-group, open-label, phase 3 randomised controlled trial. Lancet Respir Med. 2024 Feb;12(2):153-166. doi: 10.1016/S2213-2600(23)00374-0. Epub 2023 Dec 21.
PubMed 38142697Perger E, Inami T, Lyons OD, Alshaer H, Smith S, Floras JS, Logan AG, Arzt M, Duran Cantolla J, Delgado D, Fitzpatrick M, Fleetham J, Kasai T, Kimoff RJ, Leung RST, Lorenzi Filho G, Mayer P, Mielniczuk L, Morrison DL, Parati G, Parthasarathy S, Redolfi S, Ryan CM, Series F, Tomlinson GA, Woo A, Bradley TD; ADVENT-HF Investigators. Distinct Patterns of Hyperpnea During Cheyne-Stokes Respiration: Implication for Cardiac Function in Patients With Heart Failure. J Clin Sleep Med. 2017 Nov 15;13(11):1235-1241. doi: 10.5664/jcsm.6788.
PubMed 29065956
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Randomized Study to Assess the Effects of Adaptive Servo Ventilation (ASV) on Survival and Frequency of Hospital Admissions in Patients With Heart Failure (HF) and Sleep Apnea (SA)-The ADVENT-HF Trial
- ClinicalTrials.gov ID
- NCT01128816
- Acronym / sponsor ID
- ADVENT-HF / ADVENT-HF trial
- Conditions
- Sleep Apnea, Heart Failure
- Keywords
- obstructive sleep apnea, central sleep apnea, heart failure, congestive heart failure, adaptive servo ventilation, ASV
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Philips Global Field Safety Notice for PAP Devices \& Ventilators, June 14, 2021 (June 15, 2021 censor date for trial). Patient final visits and collection of endpoints prior to censor date continued to March 31, 2022.
- Enrolment
- 732 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Philips Respironics
- Study start
- May 2010
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 24 May 2010 (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.
Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of hospitalizations and death. It is not known however whether treating SA reduces these risks. This study is looking at whether a respiratory device known as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations and death in subjects with HF and SA. Study subjects will randomly receive either their regular medications OR their regular medications plus ASV. They will be followed for approximately 5 years and information relevant to their health will be collected and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard HF therapy | No intervention | –Subjects will receive optimal standard therapy for heart failure conforming to national guidelines as determined by the referring cardiologist |
| Standard therapy for HF + ASV | Active comparator | Device: Adaptive Servo VentilationSubjects will receive treatment with Adaptive Servo Ventilation in addition to optimal standard therapy for heart failure conforming to national guidelines, as determined by the referring cardiologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- American Heart Association Stage B-D Heart failure due to ischemic, idiopathic or hypertensive causes, present for at least 3 months
- Left Ventricular Ejection Fraction ≤ 45 %
- Optimal medical therapy for heart failure
- No change in active cardiac medications for 2 weeks prior to randomization, beta-blockers must be started 3 months prior to randomization
- Sleep apnea with an AHI ≥ 15. Subjects with obstructive sleep apnea must also have an Epworth Sleepiness Scale score of ≤ 10 and no or mild daytime sleepiness
Key exclusion criteria (14 listed)
- Heart failure due to primary valvular heart disease
- Presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease
- Hypertrophic obstructive or restrictive or post partum cardiomyopathy
- Exercise capacity limited by class IV angina pectoris
- Acute MI, cardiac surgery, PCI, AICD, or CRT within 3 months of randomization
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 |
|---|---|---|
| Adaptive Servo VentilationAlso: BiPAP autoSV ADVANCED, ASV, RespironicsBiPAP autoSV ADVANCED device worn nightly during sleep | Device | Standard therapy for HF + ASV |
Primary outcome
The time to the composite outcome of death or first CV hospital admission or new onset atrial fibrillation/flutter requiring anti-coagulation but not hospitalization or delivery of an appropriate shock from an ICD not resulting in hospitalization.
Time frame: The expected study follow-up period is five years
The study will end once 540 primary endpoints have occurred. The maximum follow-up period for all randomized subjects is 5 years.
10 secondary outcomes
Time to death from any cause
Time frame: The expected study follow-up period is 5 years
Number of cardiovascular hospitalizations per year of follow-up
Time frame: The minimum time of follow-up is expected to be 2 years. The maximum time of follow-up is expected to be 5 years
Number of days alive not hospitalized
Time frame: Time from randomization to censoring (death, primary event or end of study)
Changes in left ventricular function
Time frame: 6 months from randomization
Changes in plasma BNP levels
Time frame: 6 months from randomization
Cardiac resynchronization therapy or defibrillator implantations
Time frame: Average number of days until first cardiac resynchronization or first defibrillator implantation
Changes in 6 minute walk test distance
Time frame: 6 months from randomization
Percentage of patients with changes in stages of heart failure and functional class
Time frame: Values obtained at study termination will be compared to those obtained at randomization
Changes in apnea/hypopnea index
Time frame: 1 month from randomization
Changes in Quality of life assessments
Time frame: Assessments made at baseline, 1, 6, 12 and every 6 months thereafter
Results and safety
The study was stopped early (reason given: Philips Global Field Safety Notice for PAP Devices \& Ventilators, June 14, 2021 (June 15, 2021 censor date for trial). Patient final visits and collection of endpoints prior to censor date continued to March 31, 2022.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Derived from this study: PubMed 41865991Floras JS, Logan AG, Tomlinson G, Bradley TD; ADVENT-HF Investigators. Win Ratio Analysis for Peak-Flow Adaptive Servoventilation in Treating Sleep Apnoea in Heart Failure With Reduced Ejection Fraction. Can J Cardiol. 2026 Jul;42(7):1529-1537. doi: 10.1016/j.cjca.2026.03.019. Epub 2026 Mar 20.
- Derived from this study: PubMed 39168180Horvath CM, Fisser C, Floras JS, Sossalla S, Wang S, Tomlinson G, Rankin F, Yatsu S, Ryan CM, Bradley TD, Arzt M; ADVENT-HF Investigators. Nocturnal Cardiac Arrhythmias in Heart Failure With Obstructive and Central Sleep Apnea. Chest. 2024 Dec;166(6):1546-1556. doi: 10.1016/j.chest.2024.08.003. Epub 2024 Aug 20.
- Derived from this study: PubMed 38142697Bradley TD, Logan AG, Lorenzi Filho G, Kimoff RJ, Duran Cantolla J, Arzt M, Redolfi S, Parati G, Kasai T, Dunlap ME, Delgado D, Yatsu S, Bertolami A, Pedrosa R, Tomlinson G, Marin Trigo JM, Tantucci C, Floras JS; ADVENT-HF Investigators. Adaptive servo-ventilation for sleep-disordered breathing in patients with heart failure with reduced ejection fraction (ADVENT-HF): a multicentre, multinational, parallel-group, open-label, phase 3 randomised controlled trial. Lancet Respir Med. 2024 Feb;12(2):153-166. doi: 10.1016/S2213-2600(23)00374-0. Epub 2023 Dec 21.
- Derived from this study: PubMed 29065956Perger E, Inami T, Lyons OD, Alshaer H, Smith S, Floras JS, Logan AG, Arzt M, Duran Cantolla J, Delgado D, Fitzpatrick M, Fleetham J, Kasai T, Kimoff RJ, Leung RST, Lorenzi Filho G, Mayer P, Mielniczuk L, Morrison DL, Parati G, Parthasarathy S, Redolfi S, Ryan CM, Series F, Tomlinson GA, Woo A, Bradley TD; ADVENT-HF Investigators. Distinct Patterns of Hyperpnea During Cheyne-Stokes Respiration: Implication for Cardiac Function in Patients With Heart Failure. J Clin Sleep Med. 2017 Nov 15;13(11):1235-1241. doi: 10.5664/jcsm.6788.
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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.
Douglas Bradley, M.D. study chair
Toronto Rehabilitation Institute
49 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Servo Ventilation in people with Sleep Apnea and Heart Failure, run by Toronto Rehabilitation Institute at 49 sites in 9 countries.
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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Canada, Spain, France, Italy, Japan and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Philips Global Field Safety Notice for PAP Devices \& Ventilators, June 14, 2021 (June 15, 2021 censor date for trial). Patient final visits and collection of endpoints prior to censor date continued to March 31, 2022.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to the composite outcome of death or first CV hospital admission or new onset atrial fibrillation/flutter requiring anti-coagulation but not hospitalization or delivery of an appropriate shock from an ICD not resulting in hospitalization. (time frame: The expected study follow-up period is five years). 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 NCT01128816, which also lists 4 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 22 Nov 2022.