NCT01164592

Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

SERVE-HF: Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result of treatment of predominant central sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF study.

Detailed description

This substudy is performed within the SERVE-HF Study, a randomised, multi-centre,international trial with parallel group design, with patients randomised to either control (optimal medical management) or active treatment (optimal medical treatment plus use of adaptive servoventilation) in a 1:1 ratio. The randomization will be the same as in the parent study. For this purpose, the randomization of the parent study will be stratified as to whether a patient is included in the substudy or not. 300 patients will be recruited for the substudy overall. For the purpose of this substudy, patients will be followed up for a period of 12 months. The following extra tests will be performed at the baseline visit, the 3 months follow up and the 12 months follow up: * Echocardiogram (for both groups) * cMRI (for both groups) * PSG (at the baseline visit only for patients in the treatment group and at 3 months follow up and the 12 months follow up for all patients) * 4 questionnaires (for both groups) * Additional blood testing (for both groups)

Conditions

• Heart Failure
• Sleep Disorder
• Cheyne Stokes Respiration

Interventions

Type	Name	Description
DEVICE	adaptive servoventilation (ASV)	Patients randomised to therapygroup should use the adaptive servoventilation (ASV) device each night at least 3 hours

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2010-07-16
• Last updated: 2015-08-07

Locations

94 sites across 8 countries: Australia, Czechia, Finland, France, Germany, Netherlands, Switzerland, United Kingdom