Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing
This study is currently recruiting participants.
Verified August 2012 by Ruhr University of Bochum
Sponsor:
Ruhr University of Bochum
Information provided by (Responsible Party):
Olaf Oldenburg, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01657188
First received: July 27, 2012
Last updated: August 3, 2012
Last verified: August 2012
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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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657188
Contacts
| Contact: Olaf Oldenburg, M.D. | 49 5731 ext 971258 | ooldenburg@hdz-nrw.de |
| Contact: Astrid Kleemeyer | 49 5731 ext 971258 | akleemeyer@hdz-nrw.de |
Locations
| Germany | |
| Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum | Recruiting |
| 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: | August 3, 2012 |
| 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:
|
Apnea Heart Failure Sleep Apnea Syndromes Heart Failure, Systolic Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Heart Diseases Cardiovascular Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013