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

Heart Failure, Congestive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657188
• Other study ID #: HDZNRW_KA_001_OO
• Status: Completed
• Start date: May 2009
• Est. completion date: December 2017

Study information

• Verified date: September 2019
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: December 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adaptive Servoventilation
• Heart Failure
• Heart Failure, Congestive
• Heart Failure, Systolic
• Sleep Apnea Syndromes

Intervention

Device:
• Cheyne-Stokes respiration by adaptive servoventilation

Locations

Country	Name	City	State
Germany	Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum	Bad Oeynhausen

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of adaptive servoventilation on heart failure parameters including event free survival	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.	Time frame for event free survival analysis is up to 8 years