Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, Detection of Non-Dippers
Home Versus Ambulatory Monitoring in the Assessment of the Diurnal Blood Pressure Profile and the Detection of Non-Dippers
This is a cross-sectional study, including adults, either untreated for hypertension, or under stable treatment for more than four weeks. Assessment will include:
Clinic blood pressure measurements with an automated oscillometric device, 24-hour ambulatory blood pressure monitoring Home blood pressure monitoring during morning, evening and nocturnal measurements with the same device.
Přehled studie
Detailní popis
Eligible patients, as described in Inclusion/Exclusion Criteria, will be instructed to use Microlife WatchBP Home-Nocturnal oscillometric device, in order to measure their BP two times with one-minute interval, in the morning between 6 and 9 am and in the evening between 6 and 9 pm respectively for six days. These six days shall be normal working days, selected be the patient, within a time-frame of two weeks approximately. Patients should be sitting for at least five minutes and calm. During three out of those six days, they will apply and activate the same device, in order to take BP measurements while they will be asleep. Those measurements are going to be taken automatically by the device, the first 2-hours after the activation and another two with one-hour interval. Measurements will be averaged as awake and asleep BP values, with a potential to derive, if so wished, separate averages of awake-morning and awake-evening BP values.
Microlife WatchBP O3 Ambulatory Blood Pressure Measurement (ABPM) device will be applied by a doctor to each patient and it will be removed the next day by a doctor. BP measurements will be performed every 20 minutes for 24 hours. BP measurements taken during awake and asleep hours for each patient, will be analyzed separately.
Additionally, triplicate sitting Clinic Blood Pressure measurements, with one-minute interval, will be performed with the Microlife WatchBP Home-Nocturnal device during each patient's visit at the Hypertension Center. Patients will visit Hypertension Center three times, one to apply the ABPM device and one to remove it and provide the Microlife WatchBP Home-Nocturnal device and another one to bring it back. This will take approximately two weeks.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Athens, Řecko, 11527
- Sotiria General Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:ma
- Patients referred for high blood pressure
- Age over 30 years
- Untreated for hypertension or under stable treatment for 4 weeks or more
- Patients physically and mentally capable for self-measurement of blood pressure at home
- Written informed consent to participate in the study
Exclusion Criteria:
- Sustained arrythmia
- Pregnancy
- Symptomatic cardiovascular disease
- Any other serious disease (renal failure, heart failure, malignancy)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Nerandomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: All patients
All eligible patients in the study consist a single group and the same intervention is assigned to all of them.
|
Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Awake Systolic Home Blood Pressure Measurement
Časové okno: 2 weeks
|
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
|
2 weeks
|
|
Awake Diastolic Home Blood Pressure Measurement
Časové okno: 2 weeks
|
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
|
2 weeks
|
|
Asleep Systolic Home Blood Pressure Measurement
Časové okno: 2 weeks
|
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
|
2 weeks
|
|
Asleep Diastolic Home Blood Pressure Measurement
Časové okno: 2 weeks
|
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
|
2 weeks
|
|
Awake Systolic Ambulatory Blood Pressure Measurement
Časové okno: 2 weeks
|
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed.
Measurements taken during patient's awake and asleep hours are analyzed separately.
|
2 weeks
|
|
Awake Diastolic Ambulatory Blood Pressure Measurement
Časové okno: 2 weeks
|
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed.
Measurements taken during patient's awake and asleep hours are analyzed separately.
|
2 weeks
|
|
Asleep Systolic Ambulatory Blood Pressure Measurement
Časové okno: 2weeks
|
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed.
Measurements taken during patient's awake and asleep hours are analyzed separately.
|
2weeks
|
|
Asleep Diastolic Ambulatory Blood Pressure Measurement
Časové okno: 2weeks
|
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed.
Measurements taken during patient's awake and asleep hours are analyzed separately.
|
2weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Dippers Defined by ABPM and HBPM-Nocturnal
Časové okno: 2 weeks
|
As Dippers are defined the patients who displayed a nocturnal fall (Daytime-Nighttime BP/Daytime BP) in Systolic and/or Diastolic Blood Pressure by 10% or more, by each method.
The rest of patients, with a nocturnal fall by less than 10% or even a rise of BP, are consequently defined as Non-Dippers.
|
2 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NOCTURNAL
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Blood Pressure Monitoring
-
Ascensia Diabetes CareDokončeno
-
University of PennsylvaniaDokončeno
-
Biotronik SE & Co. KGDokončenoFibrilace komor | Ventrikulární tachykardie | Městnavé srdeční selháníDánsko, Německo, Izrael, Austrálie, Rakousko, Česká republika, Lotyšsko
-
Assiut UniversityZatím nenabírámePředčasný ventrikulární komplex
-
Insel Gruppe AG, University Hospital BernUkončeno
-
Yuksek Ihtisas UniversityDokončenoPandemie covid-19Krocan
-
University of PennsylvaniaNational Institute of Nursing Research (NINR)DokončenoSrdeční selháníSpojené státy
-
Abbott Medical DevicesDokončenoLéčba městnavého srdečního selháníItálie
-
Indiana UniversityUniversity of Notre Dame; Elevate Ventures; NearWave Corp.NáborRakovina prsu | HER2-pozitivní rakovina prsu | Invazivní karcinom prsu | HER2-negativní rakovina prsu | TNBC - Triple-negativní rakovina prsuSpojené státy
-
Ottawa Heart Institute Research CorporationDokončeno