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

Primary Purpose

Heart Failure, Central Sleep Apnea

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
CRT + AOP
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Sleep Apnea, CRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Klinik und Poliklinik II Universitätsklinikum, University of Bonn
  • Georg-August-Universität, Department of Cardiology and Pneumology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

CRT for patients with CSA

CRT + AOP for patients with CSA

Arm Description

Patients suffering from HF with central Sleep Apnea (CSA) programmed to DDD/45 (CRT) for 12 weeks. Intervention is CRT.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

NYHA class
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on NYHA
Echocardiographic parameter
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on LVEF
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
Clinical parameter
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on the clinical parameter VO2max
Quality of Life
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on Quality of life

Full Information

First Posted
October 30, 2007
Last Updated
December 22, 2017
Sponsor
Medtronic Bakken Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT00551499
Brief Title
Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF
Acronym
Morpheus
Official Title
Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 2005 (Actual)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Central Sleep Apnea
Keywords
Sleep Apnea, CRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT for patients with CSA
Arm Type
No Intervention
Arm Description
Patients suffering from HF with central Sleep Apnea (CSA) programmed to DDD/45 (CRT) for 12 weeks. Intervention is CRT.
Arm Title
CRT + AOP for patients with CSA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CRT + AOP
Intervention Description
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.
Primary Outcome Measure Information:
Title
AHI
Description
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
NYHA class
Description
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on NYHA
Time Frame
12 weeks
Title
Echocardiographic parameter
Description
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on LVEF
Time Frame
12 weeks
Title
Neurohormonal parameter
Description
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on neurohormonal marker NT pro-BNP
Time Frame
12 weeks
Title
Clinical parameter
Description
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on the clinical parameter VO2max
Time Frame
12 weeks
Title
Quality of Life
Description
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on Quality of life
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S Andreas, Prof. Dr
Organizational Affiliation
Georg-August-Universität, Göttingen, Department of Cardiology and Pneumology, Robert-Koch Str. 40, 37075 Göttingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik und Poliklinik II Universitätsklinikum, University of Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Georg-August-Universität, Department of Cardiology and Pneumology
City
Göttingen
ZIP/Postal Code
D-37075
Country
Germany

12. IPD Sharing Statement

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

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