Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF (Morpheus)

• ClinicalTrials.gov Identifier: NCT00551499
• Recruitment Status: Completed
• First Posted: October 31, 2007
• Last Update Posted: December 27, 2017
• Sponsor: Medtronic Bakken Research Center
• Information provided by (Responsible Party): Medtronic Bakken Research Center

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Heart Failure; Central Sleep Apnea	Device: CRT + AOP	Phase 4

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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 (Participant)
• Primary Purpose: Treatment
• Official Title: Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF
• Actual Study Start Date: June 2005
• Actual Primary Completion Date: December 2006
• Actual Study Completion Date: December 2006

Arms and Interventions

Arm	Intervention/treatment
No Intervention: CRT for patients with CSA; Patients suffering from HF with central Sleep Apnea (CSA) programmed to DDD/45 (CRT) for 12 weeks. Intervention is CRT.
Active Comparator: CRT + AOP for patients with CSA; 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.	Device: CRT + AOP; 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.

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. NYHA class [ Time Frame: 12 weeks ]
   To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on NYHA
2. Echocardiographic parameter [ Time Frame: 12 weeks ]
   To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on LVEF
3. Neurohormonal parameter [ Time Frame: 12 weeks ]
   To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on neurohormonal marker NT pro-BNP
4. Clinical parameter [ Time Frame: 12 weeks ]
   To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on the clinical parameter VO2max
5. Quality of Life [ Time Frame: 12 weeks ]
   To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on Quality of life

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Germany

Medizinische Klinik und Poliklinik II Universitätsklinikum, University of Bonn

Bonn, Germany, 53105

Georg-August-Universität, Department of Cardiology and Pneumology

Göttingen, Germany, D-37075

Sponsors and Collaborators

Medtronic Bakken Research Center

Investigators

• Principal Investigator: S Andreas, Prof. Dr; Georg-August-Universität, Göttingen, Department of Cardiology and Pneumology, Robert-Koch Str. 40, 37075 Göttingen, Germany

More Information

• Responsible Party: Medtronic Bakken Research Center
• ClinicalTrials.gov Identifier: NCT00551499
• Other Study ID Numbers: 113
• First Posted: October 31, 2007
• Last Update Posted: December 27, 2017
• Last Verified: December 2017

Keywords provided by Medtronic Bakken Research Center:

Sleep Apnea, CRT

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Central; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases