- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05014529
The Continuous Positive Airway Pressure Effect on Rho-associated Coiled-coil Containing Kinases Activity.
18. september 2021 opdateret af: Chung-Chieh, Yu, Chang Gung Memorial Hospital
The Continuous Positive Airway Pressure Effect on Rho-associated Coiled-coil Containing Kinases Activity and Left Ventricle Mass in Obstructive Sleep Apnea-hypopnea Syndrome.
The ROCK (Rho-associated coiled-coil containing kinases) play a critical role in the pathogenesis of cardiovascular diseases and left ventricle hypertrophy (LVH).
ROCK activity can be used as a clinical biomarker for the diagnosis and monitoring of cardiovascular disorders.
Obstructive sleep apnea (OSA) increase cardiovascular disease and LVH.
Continuous positive airway pressure (CPAP) is the standard therapy for OSA.
This study investigate the effect of CPAP on ROCK activity and left ventricle mass.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
The ROCK were discovered as downstream targets of Ras homologous A and regulate various important cellular functions, including proliferation, migration, adhesion, and apoptosis.
They play a critical role in the pathogenesis of cardiovascular diseases, including cardiac fibrosis, hypertrophy, and remodeling.
ROCK activity can be detected in human circulating leukocytes and could potentially be used as a clinical biomarker for the diagnosis and monitoring of cardiovascular disorders.
It has been proven that higher ROCK activity is present in left ventricle hypertrophy (LVH) patients than those without LVH.
Obstructive sleep apnea(OSA) is characterized by recurrent collapse of the pharyngeal airway during sleep that leads to intermittent nocturnal hypoxia, resulting in a broad range of cardiovascular morbidities, including coronary artery disease, heart failure, cardiac arrhythmias, and LVH.
Continuous positive airway pressure (CPAP) is the standard therapy for OSA and several studies have shown that it can effectively reduce cardiovascular disease, but the effect of CPAP on left ventricle mass reduction is still uncertain.
Previous studies demonstrated that patients with OSA had higher circulatory ROCK activity than those without OSA, but the role of CPAP on ROCK activity is not known.
The circulatory leukocyte ROCK activity may be used as a clinical biomarker for cardiovascular disease and ROCK inhibitors may be used in the future as a treatment.
OSA and CPAP treatment may also affect ROCK activity, the relationship between CPAP treatment, cardiac hypertrophy, and ROCK activity is important and should be clarified.
Therefore, the main purpose of our study is to evaluate the effect of CPAP on ROCK activity and left ventricle mass.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
160
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Chung-Chieh Yu, MD
- Telefonnummer: 2657 886+22432-9292
- E-mail: terminatorchieh@yahoo.com.tw
Undersøgelse Kontakt Backup
- Navn: Ning-I Yang, MD
- Telefonnummer: 6203 886+22431-3131
- E-mail: r3675@cgmh.org.tw
Studiesteder
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Keelung, Taiwan, 204
- Rekruttering
- Sleep center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Subjects who have snoring or any other symptoms of sleep breathing disorders receive a standard polysomnography study in the Chang Gung Sleep Center of Keelung.
Beskrivelse
Inclusion Criteria:
● Subjects who complete a standard polysomnography study.
Exclusion Criteria:
- Patients who have heart failure (as determined by clinical symptoms or signs with elevated brain natriuretic peptide and echocardiography showing structural or functional abnormalities)
- Coronary artery disease (stress electrocardiography, myocardial scintigraphy, or coronary angiography proven coronary artery lesion)
- Hypertrophic cardiomyopathy
- Known infiltrative disease e.g. amyloidosis
- Chronic kidney disease severe than stage III
- Ischemic or hemorrhagic stroke
- Central sleep apnea,
- Hypoventilation syndrome (TCO2 or artery PaCO2 exceed 50 mmHg)
- Unstable hemodynamic state
- Eastern Cooperative Oncology Group Performance Status higher than grade 2
- Pregnant women will be excluded.
- Polysomnography exam showing sleep time less than 2 hours
- Patients who receive surgery or oral appliance during the study period
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Control group
Polysomography show AHI less than 15 events/h and participants do not receive any intervention include CPAP, oral appliance, or surgery for 6 months.
|
OSA without CPAP group
Polysomography show AHI greater than 15 events/h and participants do not receive any intervention include CPAP, oral appliance, or surgery for 6 months.
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OSA with CPAP group
Polysomography show AHI greater than 15 events/h and participants receive CPAP more than 6 months.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
ROCK activity
Tidsramme: Check baseline blood ROCK 1, ROCK 2, and MYTP-1 p/t and follow up these levels in six months later.
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Compare the change of blood ROCK 1, ROCK 2, and MYTP-1 p/t (The levels of phosphorylated to total myosin light chain phosphatase 1) among those three groups.
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Check baseline blood ROCK 1, ROCK 2, and MYTP-1 p/t and follow up these levels in six months later.
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Left ventricle mass
Tidsramme: Do baseline echocardiography and follow up echocardiography in six months later.
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Compare the change left ventricle mass index among those three groups.
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Do baseline echocardiography and follow up echocardiography in six months later.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Blood pressure
Tidsramme: Obtain initial and blood pressure six months later.
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Compare the blood pressure among those three groups.
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Obtain initial and blood pressure six months later.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Julian L, Olson MF. Rho-associated coiled-coil containing kinases (ROCK): structure, regulation, and functions. Small GTPases. 2014;5:e29846. doi: 10.4161/sgtp.29846. Epub 2014 Jul 10.
- Sekizuka H, Osada N, Akashi YJ. Impact of obstructive sleep apnea and hypertension on left ventricular hypertrophy in Japanese patients. Hypertens Res. 2017 May;40(5):477-482. doi: 10.1038/hr.2016.170. Epub 2016 Dec 1.
- Stewart MH, Lavie CJ, Shah S, Englert J, Gilliland Y, Qamruddin S, Dinshaw H, Cash M, Ventura H, Milani R. Prognostic Implications of Left Ventricular Hypertrophy. Prog Cardiovasc Dis. 2018 Nov-Dec;61(5-6):446-455. doi: 10.1016/j.pcad.2018.11.002. Epub 2018 Nov 6.
- Zhang L, Zhuang JH, Peng H, Huang J, Huang LQ, Zhao ZX. Correlation between endothelial dysfunction, Rho-associated protein kinase activity, C-reactive protein and obstructive sleep apnoea syndrome in male patients. J Int Med Res. 2012;40(6):2183-90. doi: 10.1177/030006051204000616.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. oktober 2021
Primær færdiggørelse (Forventet)
1. juni 2024
Studieafslutning (Forventet)
1. december 2024
Datoer for studieregistrering
Først indsendt
14. august 2021
Først indsendt, der opfyldte QC-kriterier
14. august 2021
Først opslået (Faktiske)
20. august 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 202009223870
Plan for individuelle deltagerdata (IPD)
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UBESLUTET
IPD-planbeskrivelse
Requestors need application and explain the purpose.
The data access will be provided after approved by review panel.
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