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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Olaf Oldenburg, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01657188
First received: July 27, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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 Intervention
Heart Failure, Congestive
Sleep Apnea Syndromes
Adaptive Servoventilation
Device: Cheyne-Stokes respiration by adaptive servoventilation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1500
Study Start Date: May 2009
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 27, 2012
Last Updated: March 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on November 27, 2014