Heart Failure, CongestiveNCT01657188
Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing
An observational study of Heart Failure, Congestive and Sleep Apnea Syndromes, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Prospective, follow-up registry of heart failure patients with or without sleep-disordered breathing (SDB). To test the hypothesis that treatment of nocturnal central sleep apnea with Cheyne-Stokes respiration by adaptive servoventilation (ASV) improves symptoms, cardiac performance and event-free survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive, Sleep Apnea Syndromes, Adaptive Servoventilation
- What is being tested?
- Cheyne-Stokes respiration by adaptive servoventilation
- Type of treatment
- Medical device
- How many people
- 550 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Dec 2017
- Phase
- Observational
- 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
Study population: Patients of a university hospital
Who may be able to join
- Stable heart failure NYHA ≥ II
- EF ≤ 45%
- without sleep-disordered breathing (apnea-hypopnea-index <5/h) and those with moderate to severe central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation therapy
Who cannot join
- Cardiac resynchronization or pacemaker implantation within the last 6 months
- Significant COPD with an forced expiratory one-second capacity relative to vital capacity (FEV1/VC)< 70% (GOLD III)
- Respiratory insufficiency requiring long-term oxygen therapy
- Daytime hypercapnia at rest (pCO2 > 45 mmHg)
- Current ventilation therapy
- Cardiac surgery, PCI, myocardial infarction, unstable angina, TIA or stroke within 12 weeks prior to randomization
- Acute myocarditis within 6 months prior to randomization
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum
Bad Oeynhausen, 32545
About this study
Prospective, follow-up registry of heart failure patients with or without sleep-disordered breathing (SDB). To test the hypothesis that treatment of nocturnal central sleep apnea with Cheyne-Stokes respiration by adaptive servoventilation (ASV) improves symptoms, cardiac performance and event-free survival.
Read the detailed description
The study is intended to investigate therapeutic effects of adaptive servoventilation in patients with sleep-disordered breathing and chronic heart failure. These effects include short-/long-term effects on
- symptoms and quality of life
- physical and cardiac performance (6min walking test, cardiopulmonary exercise testing)
- echocardiographic parameters
- arrhythmias
- NT-proBNP
- Respiratory stability (blood gases, rebreathing test, VE/VCO2-slope in cardiopulmonary exercise testing)
- Compliance with ASV therapy
- Event free survival (death, heart transplantation, assist device implantation)
All of these data are also obtained in patients who basically meet the inclusion criteria but in whom sleep-disordered breathing was excluded by means of cardiorespiratory polygraphy or polysomnography and in patients with sleep-disordered breathing who do not undergo adaptive servoventilation for various reasons.
- Being tested
- Cheyne-Stokes respiration by adaptive servoventilation
- Keywords
- Heart failure, congestive, Sleep apnea syndromes, Adaptive servoventilation, Prognosis, Cheyne-Stokes respiration
- Medical subject headings
- Heart Failure, Sleep Apnea Syndromes, Cheyne-Stokes Respiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheyne-Stokes respiration by adaptive servoventilationDevice
| Study group | Role | What they receive |
|---|---|---|
| Heart failure, sleep-disordered breathing | Patients with stable heart failure NYHA ≥ II, EF ≤ 45% with or without central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation Receives: Device: Cheyne-Stokes respiration by adaptive servoventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of adaptive servoventilation on heart failure parameters including event free survival
This prospective registry includes heart failure patients with or without accompanied sleep-disordered breathing and investigates its influence on symptoms, cardiac function and performance, quality of life and outcome.
Measured: Time frame for event free survival analysis is up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startMay 2009
- Primary completionFeb 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olaf Oldenburg, Ruhr University of Bochum
- Investigators
- Olaf Oldenburg, M.D., Principal investigator, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657188
- Sponsor's protocol ID
- HDZNRW_KA_001_OO
- Status last verified
- Sep 2019
- First submitted
- 27 Jul 2012
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing
- ClinicalTrials.gov ID
- NCT01657188
- Acronym / sponsor ID
- HDZNRW_KA_001_OO
- Keywords
- Heart failure, congestive, Sleep apnea syndromes, Adaptive servoventilation, Prognosis, Cheyne-Stokes respiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Aug 2012 (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.
Prospective, follow-up registry of heart failure patients with or without sleep-disordered breathing (SDB). To test the hypothesis that treatment of nocturnal central sleep apnea with Cheyne-Stokes respiration by adaptive servoventilation (ASV) improves symptoms, cardiac performance and event-free survival.
Detailed description
The study is intended to investigate therapeutic effects of adaptive servoventilation in patients with sleep-disordered breathing and chronic heart failure. These effects include short-/long-term effects on
- symptoms and quality of life
- physical and cardiac performance (6min walking test, cardiopulmonary exercise testing)
- echocardiographic parameters
- arrhythmias
- NT-proBNP
- Respiratory stability (blood gases, rebreathing test, VE/VCO2-slope in cardiopulmonary exercise testing)
- Compliance with ASV therapy
- Event free survival (death, heart transplantation, assist device implantation)
All of these data are also obtained in patients who basically meet the inclusion criteria but in whom sleep-disordered breathing was excluded by means of cardiorespiratory polygraphy or polysomnography and in patients with sleep-disordered breathing who do not undergo adaptive servoventilation for various reasons.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure, sleep-disordered breathing | – | Device: Cheyne-Stokes respiration by adaptive servoventilationPatients with stable heart failure NYHA ≥ II, EF ≤ 45% with or without central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of a university hospital
Key inclusion criteria (3 listed)
- Stable heart failure NYHA ≥ II
- EF ≤ 45%
- without sleep-disordered breathing (apnea-hypopnea-index <5/h) and those with moderate to severe central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation therapy
Key exclusion criteria (8 listed)
- Cardiac resynchronization or pacemaker implantation within the last 6 months
- Significant COPD with an forced expiratory one-second capacity relative to vital capacity (FEV1/VC)< 70% (GOLD III)
- Respiratory insufficiency requiring long-term oxygen therapy
- Daytime hypercapnia at rest (pCO2 > 45 mmHg)
- Current ventilation therapy
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 |
|---|---|---|
| Cheyne-Stokes respiration by adaptive servoventilation | Device | Heart failure, sleep-disordered breathing |
Primary outcome
Influence of adaptive servoventilation on heart failure parameters including event free survival
Time frame: Time frame for event free survival analysis is up to 8 years
This prospective registry includes heart failure patients with or without accompanied sleep-disordered breathing and investigates its influence on symptoms, cardiac function and performance, quality of life and outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
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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.
Olaf Oldenburg, M.D. principal investigator
Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Congestive and Sleep Apnea Syndromes, run by Ruhr University of Bochum at 1 site in Germany.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Influence of adaptive servoventilation on heart failure parameters including event free survival (time frame: Time frame for event free survival analysis is up to 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2019.