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

NCT00551499 | Completed Phase 4

• 1 other identifier: 113
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure; Central Sleep Apnea

Keywords

Sleep Apnea, CRT

Outcome Measures

Primary Outcomes (1)

• 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)

  12 weeks

Secondary Outcomes (5)

• NYHA class

  12 weeks

• Echocardiographic parameter

  12 weeks

• Neurohormonal parameter

  12 weeks

• Clinical parameter

  12 weeks

• Quality of Life

  12 weeks

Study Arms (2)

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.

Device: CRT + AOP

Interventions

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.

CRT + AOP for patients with CSA

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (2)

Medizinische Klinik und Poliklinik II Universitätsklinikum, University of Bonn

Bonn, 53105, Germany

Location

Georg-August-Universität, Department of Cardiology and Pneumology

Göttingen, D-37075, Germany

Location

MeSH Terms

Conditions

Heart Failure; Sleep Apnea, Central; Sleep Apnea Syndromes; Creatine deficiency, X-linked

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• S Andreas, Prof. Dr

  Georg-August-Universität, Göttingen, Department of Cardiology and Pneumology, Robert-Koch Str. 40, 37075 Göttingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparing effect of CRT in patients with and without CSA + comparing effect of AOP in combination with CRT in patients with CSA

Study Record Dates

• First Submitted: October 30, 2007
• First Posted: October 31, 2007
• Study Start: June 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 3, 2025

Record last verified: 2024-04

Locations

DE (2)