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Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01657188
Recruitment Status : Active, not recruiting
First Posted : August 6, 2012
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Prospective, follow-up registry of heart failure patients with or without sleep-disordered breathing (SDB). To test the hypothesis that treatment of nocturnal central sleep apnea with Cheyne-Stokes respiration by adaptive servoventilation (ASV) improves symptoms, cardiac performance and event-free survival.

Condition or disease Intervention/treatment
Heart Failure, Congestive Sleep Apnea Syndromes Adaptive Servoventilation Device: Cheyne-Stokes respiration by adaptive servoventilation

Detailed Description:

The study is intended to investigate therapeutic effects of adaptive servoventilation in patients with sleep-disordered breathing and chronic heart failure. These effects include short-/long-term effects on

  • symptoms and quality of life
  • physical and cardiac performance (6min walking test, cardiopulmonary exercise testing)
  • echocardiographic parameters
  • arrhythmias
  • NT-proBNP
  • Respiratory stability (blood gases, rebreathing test, VE/VCO2-slope in cardiopulmonary exercise testing)
  • Compliance with ASV therapy
  • Event free survival (death, heart transplantation, assist device implantation)

All of these data are also obtained in patients who basically meet the inclusion criteria but in whom sleep-disordered breathing was excluded by means of cardiorespiratory polygraphy or polysomnography and in patients with sleep-disordered breathing who do not undergo adaptive servoventilation for various reasons.


Study Design

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing
Study Start Date : May 2009
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Heart failure, sleep-disordered breathing
Patients with stable heart failure NYHA ≥ II, EF ≤ 45% with or without central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation
Device: Cheyne-Stokes respiration by adaptive servoventilation


Outcome Measures

Primary Outcome Measures :
  1. Influence of adaptive servoventilation on heart failure parameters including event free survival [ Time Frame: Time frame for event free survival analysis is up to 8 years ]
    This prospective registry includes heart failure patients with or without accompanied sleep-disordered breathing and investigates its influence on symptoms, cardiac function and performance, quality of life and outcome.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients of a university hospital
Criteria

Inclusion Criteria:

  • Stable heart failure NYHA ≥ II
  • EF ≤ 45%
  • without sleep-disordered breathing (apnea-hypopnea-index <5/h) and those with moderate to severe central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation therapy

Exclusion Criteria:

  • Cardiac resynchronization or pacemaker implantation within the last 6 months
  • Significant COPD with an forced expiratory one-second capacity relative to vital capacity (FEV1/VC)< 70% (GOLD III)
  • Respiratory insufficiency requiring long-term oxygen therapy
  • Daytime hypercapnia at rest (pCO2 > 45 mmHg)
  • Current ventilation therapy
  • Cardiac surgery, PCI, myocardial infarction, unstable angina, TIA or stroke within 12 weeks prior to randomization
  • Acute myocarditis within 6 months prior to randomization
  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657188


Locations
Germany
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum
Bad Oeynhausen, Germany, 32545
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Olaf Oldenburg, M.D. Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum
More Information

Responsible Party: Olaf Oldenburg, Senior cardiologist, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01657188     History of Changes
Other Study ID Numbers: HDZNRW_KA_001_OO
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by Olaf Oldenburg, Ruhr University of Bochum:
Heart failure, congestive
Sleep apnea syndromes
Adaptive servoventilation
Prognosis
Cheyne-Stokes respiration

Additional relevant MeSH terms:
Heart Failure
Sleep Apnea Syndromes
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases