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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Athens、ギリシャ、11527
- Sotiria General Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：All patients
All eligible patients in the study consist a single group and the same intervention is assigned to all of them.
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Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Awake Systolic Home Blood Pressure Measurement
時間枠：2 weeks
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Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
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2 weeks
|
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Awake Diastolic Home Blood Pressure Measurement
時間枠：2 weeks
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Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
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2 weeks
|
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Asleep Systolic Home Blood Pressure Measurement
時間枠：2 weeks
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Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
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2 weeks
|
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Asleep Diastolic Home Blood Pressure Measurement
時間枠：2 weeks
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
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2weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Dippers Defined by ABPM and HBPM-Nocturnal
時間枠：2 weeks
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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.
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2 weeks
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- NOCTURNAL
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