- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02620930
Diagnosis And Treatment of Sleep Apnea in Patient With Heart Failure (DASAP-HF)
Diagnosis And Treatment of Sleep Apnea in Patient With Heart Failure DASAP-HF Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Heart Failure (HF) is a leading cause of morbidity and mortality in developed countries and a major national and global health problem involving about 2% of the overall population and 10% of the elderly.
A remarkably high proportion (around 50%) of stable optimally treated patients with HF and systolic dysfunction experience persistent, moderate-to-severe breathing disorders both during nighttime e during short-term laboratory recording.Sleep Disordered Breathing (SDB) is associated with transient hypoxia and increased sympathetic activity. Both factors could worsen Left Ventricular Ejection Function (LVEF) or increase serious arrhythmia.
Diagnosing and treating apnea may become a relevant issue in the management of HF patients . Prognostic stratification of congestive HF is an important objective in patient management. Many prognostic stratification scores have been suggested, however none has gained extensive acceptance. Variables used to generate stratification scores must be simple, clinically relevant, and readily obtainable. Furthermore, they must correlate to clinical events, such as hospitalization, Implant Cardioverter Defibrillator (ICD) intervention and mortality. ICD interventions are known to correlate with prognosis, and should thus be included among the end-points.
Cardiac resynchronization therapy (CRT) has been demonstrated to positively affect SA by reducing the apnea-hypopnea index (AHI). The recently developed implantable ventilation sensor which allows automated detection of advanced breathing disorders may provide not only the possibility to closely track the benefit of treatment but also provide further insights into the pathophysiological mechanisms linking Central Sleep Apnea (CSA) to HF. Given that the automated detection of sleep disordered breathing has been only performed in a limited cohort of patients with preserved LVEF requiring pacemaker (PM) implantation for standard bradycardia indications, one aspect requiring clarification is the assessment/validation of the performance of the automated detection in patients with HF.
The RDI is used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. These pauses in breathing must last for 10 seconds and are associated with a decrease in oxygenation of the blood. In general, the RDI can be used to classify the severity of disease (mild 5-15, moderate 15-30, and severe greater than 30). An implanted pacing device with a respiratory sensing function may provide clinically useful diagnostics and treatment for sleep-related breathing disorders.
The purpose of this study is to evaluate the performance of the APNEA Scan algorithm in patients implanted with an ICD or CRT-D device endowed with the APNEA Scan algorithm. Primary objective of this study is to evaluate the performance of RDI value calculated by APNEA Scan algorithm, as a binary discriminator of severe Sleep Apnea (SA) as detected by the gold-standard sleep study. Secondary objective of the study is to assess the incidence of clinical events after 24 months of enrollment and investigate its association with the RDI values calculated by APNEA Scan algorithm.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Florence, Italien, 50134
- Department of Heart and Vessels, University of Florence
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patient with left ventricular systolic dysfunction, left ventricular ejection fraction ≤35%, as documented at the moment of device implant, and conventional indication to CRT-D or ICD.
- Patient implanted with CRT-D or ICD endowed with continuous respiratory sensor designed for sleep apnea monitoring.
- Age 18 or above, or legal age to provide informed consent according to national law.
Exclusion Criteria:
- Patient on cardiac resynchronization therapy for a period longer than 7 days.
- Woman pregnant or planning to become pregnant.
- Patient is unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
- Patient unavailable to attend scheduled follow-up visits at the center.
- Patient life expectancy is less than 12 months.
- Patient is participating in another clinical study that may have an impact on the study endpoints.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Severe Sleep Apnea diagnosed with polysomnography
Tidsramme: 27 months
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Primary objective of this study is to evaluate the accuracy of RDI value calculated by APNEA Scan algorithm, as a binary discriminator of severe SA as detected by the gold-standard sleep study.
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27 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Incidence of clinical events
Tidsramme: 4 years
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Secondary objective of the study is to assess the incidence of clinical events after 24 months of enrollment and investigate its association with the RDI values calculated by APNEA Scan algorithm.
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4 years
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Prot. n. 2013/00 21553
Plan for individuelle deltagerdata (IPD)
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