NCT02093377

ASV for Sleep Apnea After Myocardial Infarction

Treatment of Sleep Apnea Early After Myocardial Infarction With Adaptive Servo-Ventilation - a Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: University Hospital Regensburg · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this randomized controlled trial is to test the effect of 12 weeks Adaptive Servo-Ventilation (ASV) therapy (additionally to optimal medical management of myocardial infarction) on myocardial salvage (MSI=myocardial salvage/area at risk, primary endpoint).

Detailed description

Primary Outcome Measure: myocardial salvage index, MSI \- To test the effect of 12 weeks of ASV (additionally to percutaneous coronary intervention, PCI, and optimal medical management of AMI) on myocardial salvage (myocardial salvage index, MSI, assessed by cardiovascular magnetic resonance imaging, CMR). Secondary Outcome Measures: \- To test whether ASV therapy in patients with SA early after AMI decreases infarct size and improves left ventricular remodelling (myocardial salvage, microvascular obstruction change of infarct size, infarct size at 12 weeks, change of left ventricular ejection fraction (LVEF), left ventricular systolic volume (LVSV), left ventricular diastolic volume (LVDV) and LVEF at 12 weeks; assessed with CMR). B-type natriuretic peptide (NT-proBNP) * To test whether ASV therapy in patients with SA early after AMIimproves disease specific symptom burden (Seattle Angina Questionnaire) * To test whether ASV therapy in patients with sleep apnea early after AMI suppresses sleep apnea (apneas and hypopneas/hour of sleep, mean oxygen saturation). * To test whether ASV therapy in patients with sleep apnea early after AMI increases renal function (Glomerular Filtration Rate, calculated using the 4vMDRD formula).

Conditions

• Acute Myocardial Infarction
• Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Adaptive servo-ventilation	Adaptive servo-ventilation (ASV, most recent technology of AutoSetCS device, ResMed, Sydney, Australia)

Timeline

• Start date: 2014-02-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2014-03-21
• Last updated: 2021-09-21

Locations

5 sites across 1 country: Germany