IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN (EnligHTN-II)
2021年5月4日 更新者：Abbott Medical Devices
IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN
The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.
調査の概要
詳細な説明
This is a post market, prospective, multicenter, non-randomized, single arm study of the EnligHTN™ Renal Denervation System.
Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located internationally and will be followed up to five years post procedure.
研究の種類
観察的
入学 (実際)
276
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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London、イギリス、EC1M 6BQ
- NIHR Barts Cardiovascular Biomedical Research Unit
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Sheffield、イギリス、S5 7AU
- Northern General Hospital
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Bologna、イタリア、40138
- Policlinico S.Orsola Malpighi
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Milano、イタリア、20138
- Centro Cardiologico Monzino
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Tuscany
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Massa、Tuscany、イタリア、54100
- Fondazione Toscana Gabriele Monasterio CNR
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-
-
-
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Den Haag、オランダ、2545 CH
- Haga Ziekenhuis Locatie Leyenburg
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Utrecht、オランダ、3584 CX
- UMC Utrecht
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-
-
-
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Chermside、オーストラリア、4032
- The Prince Charles Hospital
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Parkville、オーストラリア、3050
- Royal Melbourne Hospital - City Campus
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Perth、オーストラリア、6000
- Royal Perth Hospital
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South Australia
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Adelaide、South Australia、オーストラリア、5000
- Royal Adelaide Hospital
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-
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Athens、ギリシャ
- University of Athens, Ippocration Hospital
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-
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-
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Goteborg、スウェーデン、S41345
- Sahlgrenska University Hospital Gothenburg
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-
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Basque
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San Sebastián、Basque、スペイン、20014
- Hospital Universitario Donostia
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Bad Krozingen、ドイツ、79189
- Universitäts-Herzzentrum Freiburg - Bad Krozingen
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Berlin、ドイツ、13347
- Jüdisches Krankenhaus Berlin
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Essen、ドイツ、45122
- Universitatsklinikum Essen (Aor)
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Homburg、ドイツ、66421
- Universitatsklinikum des Saarlandes
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Mainz、ドイツ、55131
- Klinikum der Johannes-Gutenberg-Universität
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Trier、ドイツ、54292
- Krankenhaus der Barmherzigen Brüder
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Bavaria
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Coburg、Bavaria、ドイツ、96450
- Klinikum Coburg GmbH
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Ingolstadt、Bavaria、ドイツ、85049
- Klinikum Ingolstadt GmbH
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Hesse
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Bad Nauheim、Hesse、ドイツ、61231
- Kerckhoff-Klinik gGmbH
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Nordrhein Westfalen
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Bad Oeynhausen、Nordrhein Westfalen、ドイツ、32545
- Herz-und Diabetes Zentrum NRW
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Saxony
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Leipzig、Saxony、ドイツ、4103
- Uni-Klinik Leipzig, Intervent. Angiologie
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Dunedin、ニュージーランド、9016
- Dunedin Public Hospital
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Bergen、ノルウェー
- Haukeland Universitetssykehus
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Trondheim、ノルウェー、7006
- St. Olavs University Hospital
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Lyon、フランス、69317
- Hôpital de La Croix Rousse
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St. Etienne、フランス
- St-Etienne CHU
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Strasbourg、フランス、67091
- Hopital Civil - Universitaires de Strasbourg
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Franche-Comte
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Besancon、Franche-Comte、フランス、25030
- CHU de Besançon - Jean Minjoz
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Massy
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Paris、Massy、フランス
- Institute Cardio. Paris-Sud-Institut Jacques Cartier
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Subjects with uncontrolled hypertension
説明
Inclusion Criteria:
- Subject is ≥ 18 years of age at time of consent
- Subject must be able and willing to provide written informed consent
- Subject must be able and willing to comply with the required follow-up schedule
- Subject has office Systolic Blood Pressure ≥ 140 mmHg at confirmatory visit
- Subject has a daytime mean Systolic Ambulatory Blood Pressure > 135 mmHg within 90 days prior to procedure
- Subject has established hypertension (diagnosed ≥12 month prior to baseline) and is on a guideline based drug regimen at a stable and fully tolerated dose consisting of ≥ 3 anti-hypertensive medications (including 1 diuretic) or subject has a documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
Exclusion Criteria:
- Subject has significant renovascular abnormalities such as renal artery stenosis > 30%
- Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
- Subject has hemodynamically significant valvular heart disease as determined by study investigator
- Subject has a life expectancy less than 12 months, as determined by the Investigator
- Subject is participating in another clinical study which has the potential to impact their hypertension management (pharmaceutical/device/homeopathic)
- Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
- Subject has active systemic infection
- Subject has renal arteries with diameter(s) < 4 mm in diameter
- Subject has an estimated GFR <15 mL/min per 1.73 m^2 using the MDRD formula
- Subject had a renal transplant or is awaiting a renal transplant
- Subject has blood clotting abnormalities
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
A - EnligHTN for Severe Resistant HTN
|
Renal artery ablation with EnligHTN system used for all groups
|
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B - EnligHTN for Resistant HTN
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Renal artery ablation with EnligHTN system used for all groups
|
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C - EnligHTN for Resistant HTN & CKD
|
Renal artery ablation with EnligHTN system used for all groups
|
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 |
|---|---|---|
|
Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months
時間枠：Baseline to 6 months
|
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit.
Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements.
If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
|
Baseline to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure
時間枠：30 days post procedure
|
The peri-procedural events occurring within 30 days post procedure were summarized as the percentage of the number of participants with peri-procedural events within 30 days post procedure compared to the number of participants at baseline for that population.
|
30 days post procedure
|
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Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months
時間枠：6 months
|
The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per Renal Artery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm.
Kaplan-meier analysis was performed on the time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
|
6 months
|
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Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months
時間枠：Confirmatory visit to 6 months
|
Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
|
Confirmatory visit to 6 months
|
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Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years
時間枠：2 years
|
The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm.
Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
|
2 years
|
|
Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years
時間枠：5 years
|
The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm.
Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
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5 years
|
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Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years
時間枠：Confirmatory visit to 2 years
|
Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
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Confirmatory visit to 2 years
|
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Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years
時間枠：Confirmatory visit to 5 years
|
Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
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Confirmatory visit to 5 years
|
|
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months
時間枠：Baseline to 6 months
|
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit.
In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time.
When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours.
The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
|
Baseline to 6 months
|
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Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months
時間枠：Baseline to 6 months
|
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit.
In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time.
When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours.
The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
|
Baseline to 6 months
|
|
Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months
時間枠：Baseline to 6 months
|
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit.
Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements.
If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
|
Baseline to 6 months
|
|
Percentage of Participants Achieved Office Systolic Blood Pressure < 140 mmHg at 6 Months
時間枠：6 months
|
The percentage of participants achieved office systolic blood pressure <140 mmHg at 6 months visit was computed as the percentage of the ratio of number of participants who achievied office systolic blood pressure <140 mmHg at 6 months visit to the number of participants with data available in 6 months visit.
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6 months
|
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Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation
時間枠：Baseline to 1 year
|
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit.
Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements.
If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
|
Baseline to 1 year
|
|
Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation
時間枠：Baseline to 2 years
|
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit.
Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements.
If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
|
Baseline to 2 years
|
|
Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation
時間枠：Baseline to 3 years
|
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit.
Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements.
If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
|
Baseline to 3 years
|
|
Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation
時間枠：Baseline to 4 years
|
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit.
Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements.
If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
|
Baseline to 4 years
|
|
Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation
時間枠：Baseline to 5 years
|
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit.
Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements.
If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
|
Baseline to 5 years
|
|
Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation
時間枠：Baseline to 1 year
|
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit.
Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements.
If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
|
Baseline to 1 year
|
|
Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
時間枠：Baseline to 2 years
|
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit.
Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements.
If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
|
Baseline to 2 years
|
|
Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
時間枠：Baseline to 3 years
|
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit.
Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements.
If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
|
Baseline to 3 years
|
|
Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
時間枠：Baseline to 4 years
|
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit.
Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements.
If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
|
Baseline to 4 years
|
|
Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
時間枠：Baseline to 5 years
|
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit.
Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements.
If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
|
Baseline to 5 years
|
|
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation
時間枠：Baseline to 1 year
|
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit.
In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time.
When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours.
The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
|
Baseline to 1 year
|
|
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation
時間枠：Baseline to 2 years
|
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit.
In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time.
When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours.
The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
|
Baseline to 2 years
|
|
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation
時間枠：Baseline to 3 years
|
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit.
In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time.
When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours.
The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
|
Baseline to 3 years
|
|
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation
時間枠：Baseline to 4 years
|
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit.
In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time.
When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours.
The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
|
Baseline to 4 years
|
|
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation
時間枠：Baseline to 5 years
|
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit.
In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time.
When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours.
The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
|
Baseline to 5 years
|
|
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation
時間枠：Baseline to 1 year
|
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit.
In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time.
When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours.
The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
|
Baseline to 1 year
|
|
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
時間枠：Baseline to 2 years
|
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit.
In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time.
When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours.
The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
|
Baseline to 2 years
|
|
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
時間枠：Baseline to 3 years
|
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit.
In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time.
When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours.
The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
|
Baseline to 3 years
|
|
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
時間枠：Baseline to 4 years
|
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit.
In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time.
When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours.
The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
|
Baseline to 4 years
|
|
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
時間枠：Baseline to 5 years
|
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit.
In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time.
When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours.
The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
|
Baseline to 5 years
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Melvin Lobo, MBChB PhD、NIHR Barts Cardiovascular Biomedical Research Unit
- 主任研究者：Stephen Worthley, MB BS PhD、Royal Adelaide Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2013年1月17日
一次修了 (実際)
2017年4月1日
研究の完了 (実際)
2019年11月27日
試験登録日
最初に提出
2012年9月19日
QC基準を満たした最初の提出物
2012年10月10日
最初の投稿 (見積もり)
2012年10月12日
学習記録の更新
投稿された最後の更新 (実際)
2021年5月27日
QC基準を満たした最後の更新が送信されました
2021年5月4日
最終確認日
2021年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1201 (1201 XDOZ, local number)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。