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

4 maja 2021 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

276

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Subjects with uncontrolled hypertension

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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
Urządzenie: 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
Urządzenie: 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
Urządzenie: EnligHTN
Renal artery ablation with EnligHTN system used for all groups

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Abbott Medical Devices

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

17 stycznia 2013

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2017

Ukończenie studiów (Rzeczywisty)

27 listopada 2019

Daty rejestracji na studia

Pierwszy przesłany

19 września 2012

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 października 2012

Pierwszy wysłany (Oszacować)

12 października 2012

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

27 maja 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 maja 2021

Ostatnia weryfikacja

1 maja 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 1201 (1201 XDOZ, local number)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

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Badania kliniczne na EnligHTN

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Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

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Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

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