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Completed

NCT Number: NCT00551499

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

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.

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Key information

Conditions

Heart Failure Apnea Cardiovascular Diseases Central Sleep Apnea Creatine deficiency, X-linked Dyssomnias Heart Diseases Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medizinische Klinik und Poliklinik II Universitätsklinikum, University of Bonn, Bonn, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRT + AOP

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: Morpheus

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 31, 2007
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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