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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.

研究概览

地位

终止

条件

干预/治疗

设备：EnligHTN

详细说明

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.

研究类型

观察性的

注册 (实际的)

276

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

希腊
- - Athens、希腊
    - University of Athens, Ippocration Hospital
德国
- - Bad Krozingen、德国、79189
    - Universitäts-Herzzentrum Freiburg - Bad Krozingen
  - Berlin、德国、13347
    - Jüdisches Krankenhaus Berlin
  - Essen、德国、45122
    - Universitatsklinikum Essen (Aor)
  - Homburg、德国、66421
    - Universitatsklinikum des Saarlandes
  - Mainz、德国、55131
    - Klinikum der Johannes-Gutenberg-Universität
  - Trier、德国、54292
    - Krankenhaus der Barmherzigen Brüder
- Bavaria
  - Coburg、Bavaria、德国、96450
    - Klinikum Coburg GmbH
  - Ingolstadt、Bavaria、德国、85049
    - Klinikum Ingolstadt GmbH
- Hesse
  - Bad Nauheim、Hesse、德国、61231
    - Kerckhoff-Klinik gGmbH
- Nordrhein Westfalen
  - Bad Oeynhausen、Nordrhein Westfalen、德国、32545
    - Herz-und Diabetes Zentrum NRW
- Saxony
  - Leipzig、Saxony、德国、4103
    - Uni-Klinik Leipzig, Intervent. Angiologie
意大利
- - Bologna、意大利、40138
    - Policlinico S.Orsola Malpighi
  - Milano、意大利、20138
    - Centro Cardiologico Monzino
- Tuscany
  - Massa、Tuscany、意大利、54100
    - Fondazione Toscana Gabriele Monasterio CNR
挪威
- - Bergen、挪威
    - Haukeland Universitetssykehus
  - Trondheim、挪威、7006
    - St. Olavs University Hospital
新西兰
- - Dunedin、新西兰、9016
    - Dunedin Public Hospital
法国
- - Lyon、法国、69317
    - Hôpital de La Croix Rousse
  - St. Etienne、法国
    - St-Etienne CHU
  - Strasbourg、法国、67091
    - Hopital Civil - Universitaires de Strasbourg
- Franche-Comte
  - Besancon、Franche-Comte、法国、25030
    - CHU de Besançon - Jean Minjoz
- Massy
  - Paris、Massy、法国
    - Institute Cardio. Paris-Sud-Institut Jacques Cartier
澳大利亚
- - Chermside、澳大利亚、4032
    - The Prince Charles Hospital
  - Parkville、澳大利亚、3050
    - Royal Melbourne Hospital - City Campus
  - Perth、澳大利亚、6000
    - Royal Perth Hospital
- South Australia
  - Adelaide、South Australia、澳大利亚、5000
    - Royal Adelaide Hospital
瑞典
- - Goteborg、瑞典、S41345
    - Sahlgrenska University Hospital Gothenburg
英国
- - London、英国、EC1M 6BQ
    - NIHR Barts Cardiovascular Biomedical Research Unit
  - Sheffield、英国、S5 7AU
    - Northern General Hospital
荷兰
- - Den Haag、荷兰、2545 CH
    - Haga Ziekenhuis Locatie Leyenburg
  - Utrecht、荷兰、3584 CX
    - UMC Utrecht
西班牙
- Basque
  - San Sebastián、Basque、西班牙、20014
    - Hospital Universitario Donostia

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Subjects with uncontrolled hypertension

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列	干预/治疗
A - EnligHTN for Severe Resistant HTN Office systolic Blood Pressure ≥160 mmHg Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has 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. Patient has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula	设备：EnligHTN Renal artery ablation with EnligHTN system used for all groups
B - EnligHTN for Resistant HTN Office systolic Blood Pressure ≥140 mmHg Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has 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. Patient has an estimated GFR ≥45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula	设备：EnligHTN Renal artery ablation with EnligHTN system used for all groups
C - EnligHTN for Resistant HTN & CKD Office systolic Blood Pressure ≥140 mmHg Subject is taking ≥3 anti-hypertensive medications (including 1 diuretic), or subject has 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. Patient has an estimated ≥15 GFR <45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula	设备：EnligHTN Renal artery ablation with EnligHTN system used for all groups

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure 大体时间：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
Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months 大体时间：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
Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months 大体时间：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
Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years 大体时间：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 大体时间：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.	5 years
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years 大体时间：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.	Confirmatory visit to 2 years
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years 大体时间：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.	Confirmatory visit to 5 years
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months 大体时间：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 Ambulatory Diastolic Blood Pressure From Baseline to 6 Months 大体时间：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 大体时间：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 大体时间：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.	6 months
Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Abbott Medical Devices

调查人员

首席研究员：Melvin Lobo, MBChB PhD、NIHR Barts Cardiovascular Biomedical Research Unit
首席研究员：Stephen Worthley, MB BS PhD、Royal Adelaide Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年1月17日

初级完成 (实际的)

2017年4月1日

研究完成 (实际的)

2019年11月27日

研究注册日期

首次提交

2012年9月19日

首先提交符合 QC 标准的

2012年10月10日

首次发布 (估计)

2012年10月12日

研究记录更新

最后更新发布 (实际的)

2021年5月27日

上次提交的符合 QC 标准的更新

2021年5月4日

最后验证

2021年5月1日

IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN (EnligHTN-II)

IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN

研究概览

地位

条件

干预/治疗

详细说明

研究类型

注册 (实际的)

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

取样方法

研究人群

描述

学习计划

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？