Malignant Arrhythmias and Adaptive Servoventilation in patients with congestive heart failure and Cheyne-Stokes respiration (MAAS-Trial)

Not Applicable

• Conditions: I50.1; R06.3; Left ventricular failure; Periodic breathing

• Registration Number: DRKS00000565
• Lead Sponsor: Kardiologische Klinik, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2010-07-15
• Study Start: 2010-10-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 446

Inclusion Criteria

a persistent impairment of systolic left ventricular function according to echocardiographic criteria (LVEF = 45%)
- stable NYHA-class = II
- implanted cardioverter-defibrillator device (ICD)
- implanted cardiac resynchronization therapy device with cardiover-defibrillator (CRT-D) at least 6 months prior to enrollment
- stable heart failure medication for at least 4 weeks prior to enrolment and during follow-up

Exclusion Criteria

- history of or ongoing treatment of SDB
- significant valvular heart disease
- evidence of moderate to severe pulmonary disease (FEV1/VC <70%)
- respiratory insufficiency reqiring permanent oxygen therapy
- hypercapnia (pCO2 > 45mmHg)
- pregnancy
- acute coronary syndrome
- acute myocardial decompensation
- therapy refractory restless legs syndrome

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary study outcome was defined as the event-free survival period to first appropriate cardioverter-defibrillator therapy, namely anti-tachycardia pacing and/or shock.

Secondary Outcome Measures

Name	Time	Method
- Event-free survival period to first appropriately monitored ventricular arrhythmia, including sustained and non-sustained monomorphic ventricular tachycardia, polymorphic ventricular tachycardia, ventricular flutter or ventricular fibrillation (according to ICD/CRT-device data<br>- changes in NYHA-functional class<br>(subjective, according to patient´s opinion)<br>- changes in nocturia <br>(subjective, according to patient´s opinion)<br>- changes in echocardiographic parameters (LVEF, LVEDD)<br>- changes in cardiopulmonary exercise testing results (VO2 peak, VO2 predicted, VO2 AT)<br>- changes in blood gas measurements (pO2, pCO2, sO2)