I50.1 G47.30 I10
Conditions
Interventions
Group 1: ASV OFF-to-ON arm: During Intervention Phase I (two weeks), ASV therapy will be discontinued. Following a two-week washout period, Intervention Phase II (two weeks) will start, during which
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 prescribed in clinical routine for >6 months and mean daily use =4h per night - Stable HFpEF defined as: signs and/or symptoms of heart failure, left ventricular ejection fraction (LVEF) =45%, and objective evidence of cardiac structural and/or functional abnormalities consistent with elevated left ventricular filling pressures, including elevated natriuretic peptides defined as either NTproBNP >125 pg/mL in sinus rhythm or >365 pg/mL in atrial fibrillation, or BNP >35 pg/mL in sinus rhythm or >105 pg/mL in atrial fibrillation - Arterial BP (on ASV) in the normal, high normal or in the hypertension Grade 1 and 2 range (systolic BP =120 mmHg and diastolic BP =80 mmHg as well as systolic BP <180 mmHg and diastolic BP <110 mmHg) - Age =18 to 80 y - Adherence to stable antihypertensive and heart failure medication (=4 weeks prior to randomization), diuretics and sodium-glucose cotransporter 2 (SGLT2) inhibitors, if prescribed - Written informed consent (VENT-HF Observation and VENT-HF Blood Pressure)
Exclusion criteria
Exclusion criteria: - History of any sleep related accident or current professional drivers - Known non-tolerance of ASV withdrawal - Drug induced CSA (e.g., opioids) - Non-cardiac causes for heart failure-like symptoms (pulmonary disease, obesity with body-mass index >45 kg/m², anemia (Hb<10 g/dl)) - Secondary hypertension (other than sleep-disordered breathing) - Severe valvular heart disease - Severe pulmonary disease - Any other medical, social, or geographical factor that would make it unlikely that the patient will comply with the study procedures - Participation in concurrent placebo controlled studies in which a change in therapy occurs during participation in the VENT-HF I Blood Pressure study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean nocturnal arterial blood pressure after 2 weeks (24h Ambulatory Blood Pressure - Heart Rate Monitoring, 24h ABPM, “nocturnal” def. by sleep according to integrated actigraphic recording) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Nocturnal and diurnal systolic and diastolic arterial BP and HR (24h ABPM) after 2 weeks • Morning systolic and diastolic arterial blood pressure (BP) as well as heart rate (HR) (daily patient self-assessment) • Sleep fragmentation and sleep structure: arousal index, sleep stage N1, N3 and rapid eye movement (REM) sleep (Polysomnography (PSG) • CSA-related symptoms: sleepiness (Epworth Sleepiness Scale (ESS); Karolinska Sleepiness Scale (KSS, daily)) and fatigue (Fatigue Severity Scale, FSS) • Disease specific (central sleep apnea (CSA) and heart failure with preserved ejection fraction (HFpEF)) quality of life (QoL): short form of the Functional Outcome of Sleep Questionnaire (FOSQ-10) and Kansas City Cardiomyopathy Questionnaire-Score (KCCQ-12) • Assessment of safety: Non-tolerance of ASV withdrawal and occurrence of Grade 3 hypertension (systolic BP =180 mmHg and/or diastolic BP =110 mmHg); incidence, severity, and frequency of any adverse events (AEs), serious adverse events (SAEs), Serious Adverse Device Effects (SADE) and Unanticipated Adverse Device Effect (UADE). | — |
Countries
Germany
Contacts
Public ContactMichael Arzt
University Hospital Regensburg, Department of Internal Medicine II
Outcome results
None listed