G47.30 I50.1 I10
Conditions
Interventions
Group 1: Patients with heart failure with preserved ejection fraction (HFpEF) and established adaptive servoventilation (ASV) therapy for central sleep apnea (CSA) will be asked about their quality of
Sponsors
University Hospital Regensburg, Department of Internal Medicine II,
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: - Established therapy with ASV (>6 months) for the treatment of - Moderate to severe CSA (Apnea-Hypopnea Index (AHI) =15/h, >50% central apneas of all apneas or >50% central apneas and hypopneas of all apneas and hypopneas) - History of hypertension - Risk for HFpEF or presence of HFpEF (LVEF =45%, NYHA II or III without alternative reason for dyspnea) - The patient is capable of providing informed consent and has voluntarily signed and dated an ICH-GCP–compliant written informed consent form prior to participation in the study
Exclusion criteria
Exclusion criteria: - Secondary hypertension (other than sleep-disordered breathing) - Drug induced CSA (e.g., opioids) - Severe valvular heart disease - Pregnant or breastfeeding people
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of uncontrolled arterial hypertension assessed by office blood pressure and /or 24-hour ABPM at time of inclusion and at least one follow-up within routine clinical care | — |
Secondary
| Measure | Time frame |
|---|---|
| - Prevalence of treatment-related CSA - ASV usage (device data) - 24h Abulatory Blood Pressure and Heart Rate Monitoring (optional) - Identification of risk factors for uncontrolled hypertension - Quality of life assessed by questionnaire EuroQol-5 Dimensions (EQ-5D) - CSA-related symptomes assessed by questionnaires Epworth Sleepiness Scale (ESS) questionnaire and Fatigue Severity Scale (FSS) - Disease-specific quality of life (sleep apnea, heart failure) assessed by the Functional Outcomes of Sleep Questionnaire – 10 items (FOSQ-10) and the Kansas City Cardiomyopathy Questionnaire – 12 items (KCCQ-12) - Incidence of Adverse Events of Special Interest (AEoSI), Serious Adverse Events (SAEs) and Major Adverse Cardiac and Cerebrovascular Events (MACCE) | — |
Countries
Germany
Contacts
Public ContactMichael Arzt
University Hospital Regensburg, Department of Internal Medicine II
Outcome results
None listed