Heart FailurePhase 4MorpheusNCT00551499
Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF
A Phase 4 study testing CRT + AOP in people with Heart Failure and Central Sleep Apnea, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in Germany.
Trial summary
The primary objective of this study is to compare the Apnea- Hypopnea Index in HF patients with concomitant CSA, after 12 weeks of CRT alone to CRT in combination with one night of overdrive pacing. Secondary objectives are to evaluate the effects of a single night of overdrive pacing applied after 12 weeks of CRT vs. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure, Central Sleep Apnea
- What is being tested?
- CRT + AOP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2005to Dec 2006
- Phase
- Phase 4
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with documented clinical history of symptomatic but stable congestive heart failure, NYHA III or NYHA IV, of at least six weeks duration.
- Patient has an indication for a CRT device, or patients with previous pacemaker indication, except Sick Sinus Syndrome, and currently in need for an upgrade to a CRT device
- Patient is scheduled for the implantation of a CRT device
- Patient is over 18 years of age
- Patient provides Informed Consent
Who cannot join
- Inability to complete overnight sleep study as specified by the protocol
- Myocardial infarction or coronary revascularization procedure within 2 calendar months prior to enrollment
- Planned or strong likelihood of cardiac surgery within 4 months following enrollment
- A spirometric confirmation of obstructive lung disease
- Evidence of obstructive sleep apnea at baseline polysomnography
- Body mass index >30 kg/m²
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Medizinische Klinik und Poliklinik II Universitätsklinikum, University of Bonn
Bonn, 53105
Georg-August-Universität, Department of Cardiology and Pneumology
Göttingen, D-37075
About this study
The primary objective of this study is to compare the Apnea- Hypopnea Index in HF patients with concomitant CSA, after 12 weeks of CRT alone to CRT in combination with one night of overdrive pacing. Secondary objectives are to evaluate the effects of a single night of overdrive pacing applied after 12 weeks of CRT vs. CRT alone on breathing events, sleeping events, and neurohormonal markers. An additional secondary objective of the study is to compare the efficacy of CRT in HF patients with concomitant CSA to HF patients without concomitant CSA.
Read the detailed description
Sleep apnea is a common and often undiagnosed disorder associated with substantial cardiovascular morbidity and mortality. In recent years studies have been published presenting the relationship between heart failure (HF) and central sleep apnea (CSA). CSA associated with Cheyne-Stokes respiration is a form of periodic breathing in which central apneas and hypopnea alternate with periods of hyperventilation, characterized by a regular crescendo-decrescendo oscillation of tidal volume, which is thought to be caused by dysfunction of central respiratory control. Unlike, obstructive sleep apnea (OSA), CSA likely arises as a consequence of HF.Since 2002, several results have reported on the benefit of atrial overdrive (AOP) pacing in patients suffering from sleep apnea. These results could not be confirmed for obstructive sleep apnea in several subsequent studies. Cardiac resynchronization therapy (CRT) has been proposed as another potential therapeutic pacing approach for CSA by two recently published investigations.The combined therapeutic impact of AOP and CRT (CRT+AOP) so far has not been investigated.We aimed to evaluate the effect of CRT alone and CRT+AOP on CSA in patients with CHF.
- Conditions
- Heart Failure, Central Sleep Apnea
- Being tested
- CRT + AOP
- Keywords
- Sleep Apnea, CRT
- Medical subject headings
- Heart Failure, Sleep Apnea, Central, Sleep Apnea Syndromes, Creatine deficiency, X-linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT + AOPDevice
The CSA group will undergo 2 sleep evaluation on two consecutive nights, during which the device will be programmed according to the randomization scheme (one night CRT, DDD/45 and the other CRT, DDD/15 bpm over mean nocturnal heart rate). The mean nocturnal heart rate over the last week is derived from the device memory.
| Study group | Role | What they receive |
|---|---|---|
| CRT for patients with CSA | No intervention | Patients suffering from HF with central Sleep Apnea (CSA) programmed to DDD/45 (CRT) for 12 weeks. Intervention is CRT. |
| CRT + AOP for patients with CSA | Active comparator | Patients suffering from HF with central Sleep Apnea programmed to DDD/+15 bpm nocturnal rate (CRT + AOP) for 12 weeks. Intervention is the AOP in addition to CRT. Receives: Device: CRT + AOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI
To demonstrate that a single night of overdrive pacing applied after 12 weeks of cardiac resynchronization therapy in comparison to cardiac resynchronization alone will improve sleep apnea as measured by Apnea- hypopnea- index (AHI)
Measured: 12 weeks
Secondary outcomes (5)
NYHA class
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on NYHA
Measured: 12 weeks
Echocardiographic parameter
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on LVEF
Measured: 12 weeks
Neurohormonal parameter
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on neurohormonal marker NT pro-BNP
Measured: 12 weeks
Clinical parameter
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on the clinical parameter VO2max
Measured: 12 weeks
Quality of Life
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on Quality of life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startJun 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Comparing effect of CRT in patients with and without CSA + comparing effect of AOP in combination with CRT in patients with CSA
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S Andreas, Prof. Dr, Principal investigator, Georg-August-Universität, Göttingen, Department of Cardiology and Pneumology, Robert-Koch Str. 40, 37075 Göttingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551499
- Sponsor's protocol ID
- 113
- Acronym
- Morpheus
- Status last verified
- Apr 2024
- First submitted
- 30 Oct 2007
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF
- ClinicalTrials.gov ID
- NCT00551499
- Acronym / sponsor ID
- Morpheus / 113
- Conditions
- Heart Failure, Central Sleep Apnea
- Keywords
- Sleep Apnea, CRT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2005 (actual)
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 31 Oct 2007 (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 primary objective of this study is to compare the Apnea- Hypopnea Index in HF patients with concomitant CSA, after 12 weeks of CRT alone to CRT in combination with one night of overdrive pacing. Secondary objectives are to evaluate the effects of a single night of overdrive pacing applied after 12 weeks of CRT vs. CRT alone on breathing events, sleeping events, and neurohormonal markers. An additional secondary objective of the study is to compare the efficacy of CRT in HF patients with concomitant CSA to HF patients without concomitant CSA.
Detailed description
Sleep apnea is a common and often undiagnosed disorder associated with substantial cardiovascular morbidity and mortality. In recent years studies have been published presenting the relationship between heart failure (HF) and central sleep apnea (CSA). CSA associated with Cheyne-Stokes respiration is a form of periodic breathing in which central apneas and hypopnea alternate with periods of hyperventilation, characterized by a regular crescendo-decrescendo oscillation of tidal volume, which is thought to be caused by dysfunction of central respiratory control. Unlike, obstructive sleep apnea (OSA), CSA likely arises as a consequence of HF.Since 2002, several results have reported on the benefit of atrial overdrive (AOP) pacing in patients suffering from sleep apnea. These results could not be confirmed for obstructive sleep apnea in several subsequent studies. Cardiac resynchronization therapy (CRT) has been proposed as another potential therapeutic pacing approach for CSA by two recently published investigations.The combined therapeutic impact of AOP and CRT (CRT+AOP) so far has not been investigated.We aimed to evaluate the effect of CRT alone and CRT+AOP on CSA in patients with CHF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Comparing effect of CRT in patients with and without CSA + comparing effect of AOP in combination with CRT in patients with CSA
| Arm | Type | Receives |
|---|---|---|
| CRT for patients with CSA | No intervention | –Patients suffering from HF with central Sleep Apnea (CSA) programmed to DDD/45 (CRT) for 12 weeks. Intervention is CRT. |
| CRT + AOP for patients with CSA | Active comparator | Device: CRT + AOPPatients suffering from HF with central Sleep Apnea programmed to DDD/+15 bpm nocturnal rate (CRT + AOP) for 12 weeks. Intervention is the AOP in addition to CRT. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with documented clinical history of symptomatic but stable congestive heart failure, NYHA III or NYHA IV, of at least six weeks duration.
- Patient has an indication for a CRT device, or patients with previous pacemaker indication, except Sick Sinus Syndrome, and currently in need for an upgrade to a CRT device
- Patient is scheduled for the implantation of a CRT device
- Patient is over 18 years of age
- Patient provides Informed Consent
Key exclusion criteria (7 listed)
- Inability to complete overnight sleep study as specified by the protocol
- Myocardial infarction or coronary revascularization procedure within 2 calendar months prior to enrollment
- Planned or strong likelihood of cardiac surgery within 4 months following enrollment
- A spirometric confirmation of obstructive lung disease
- Evidence of obstructive sleep apnea at baseline polysomnography
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 |
|---|---|---|
| CRT + AOPThe CSA group will undergo 2 sleep evaluation on two consecutive nights, during which the device will be programmed according to the randomization scheme (one night CRT, DDD/45 and the other CRT, DDD/15 bpm over mean nocturnal heart rate). The mean nocturnal heart rate over the last week is derived from the device memory. | Device | CRT + AOP for patients with CSA |
Primary outcome
AHI
Time frame: 12 weeks
To demonstrate that a single night of overdrive pacing applied after 12 weeks of cardiac resynchronization therapy in comparison to cardiac resynchronization alone will improve sleep apnea as measured by Apnea- hypopnea- index (AHI)
5 secondary outcomes
NYHA class
Time frame: 12 weeks
Echocardiographic parameter
Time frame: 12 weeks
Neurohormonal parameter
Time frame: 12 weeks
Clinical parameter
Time frame: 12 weeks
Quality of Life
Time frame: 12 weeks
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 3 Jul 2025.
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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.
S Andreas, Prof. Dr principal investigator
Georg-August-Universität, Göttingen, Department of Cardiology and Pneumology, Robert-Koch Str. 40, 37075 Göttingen, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CRT + AOP in people with Heart Failure and Central Sleep Apnea, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites 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 5 inclusion and 7 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 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
AHI (time frame: 12 weeks). 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 3 Jul 2025.