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

4 мая 2021 г. обновлено: 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.

Обзор исследования

Статус

Прекращено

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Действительный)

276

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

Subjects with uncontrolled hypertension

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
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
Устройство: 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
Устройство: 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
Устройство: EnligHTN
Renal artery ablation with EnligHTN system used for all groups

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Abbott Medical Devices

Следователи

  • Главный следователь: Melvin Lobo, MBChB PhD, NIHR Barts Cardiovascular Biomedical Research Unit
  • Главный следователь: Stephen Worthley, MB BS PhD, Royal Adelaide Hospital

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

17 января 2013 г.

Первичное завершение (Действительный)

1 апреля 2017 г.

Завершение исследования (Действительный)

27 ноября 2019 г.

Даты регистрации исследования

Первый отправленный

19 сентября 2012 г.

Впервые представлено, что соответствует критериям контроля качества

10 октября 2012 г.

Первый опубликованный (Оценивать)

12 октября 2012 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

27 мая 2021 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

4 мая 2021 г.

Последняя проверка

1 мая 2021 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 1201 (1201 XDOZ, local number)

Планирование данных отдельных участников (IPD)

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НЕТ

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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