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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000565

Enrollment

400

Registered

2010-10-01

Start date

2009-07-06

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I50.1 R06.3

Interventions

Group 1: Adaptive servoventilation (AutoSet CS II,ResMed) Group 2: no ventilation therapy

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

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

Exclusion criteria: - history of or ongoing treatment of SDB - significant valvular heart disease - evidence of moderate to severe pulmonary disease (FEV1/VC 45mmHg) - pregnancy - acute coronary syndrome - acute myocardial decompensation - therapy refractory restless legs syndrome

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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 - changes in NYHA-functional class (subjective, according to patient´s opinion) - changes in nocturia (subjective, according to patient´s opinion) - changes in echocardiographic parameters (LVEF, LVEDD) - changes in cardiopulmonary exercise testing results (VO2 peak, VO2 predicted, VO2 AT) - changes in blood gas measurements (pO2, pCO2, sO2)	—

Measure

Time frame

- 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 - changes in NYHA-functional class (subjective, according to patient´s opinion) - changes in nocturia (subjective, according to patient´s opinion) - changes in echocardiographic parameters (LVEF, LVEDD) - changes in cardiopulmonary exercise testing results (VO2 peak, VO2 predicted, VO2 AT) - changes in blood gas measurements (pO2, pCO2, sO2)

—

Countries

Germany

Contacts

Public ContactAnke Schmidt

ikfe HDZ GmbH

aschmidt@cru-hdz.de05731/972440

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026