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

4. května 2021 aktualizováno: 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.

Přehled studie

Postavení

Ukončeno

Podmínky

Intervence / Léčba

Přístroj: EnligHTN

Detailní popis

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 studie

Pozorovací

Zápis (Aktuální)

276

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Subjects with uncontrolled hypertension

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta Skupina / kohorta Skupina nebo podskupina účastníků pozorovací studie, která je hodnocena z hlediska biomedicínských nebo zdravotních výsledků.	Intervence / Léčba Intervence / Léčba Proces nebo akce, na které se klinická studie zaměřuje. Intervence zahrnují léky, zdravotnická zařízení, postupy, vakcíny a další produkty, které jsou buď zkoušené nebo již dostupné. Intervence mohou také zahrnovat neinvazivní přístupy, jako je edukace nebo úprava stravy a cvičení.
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	Přístroj: 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	Přístroj: 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	Přístroj: EnligHTN Renal artery ablation with EnligHTN system used for all groups

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months Časové okno: 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

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Abbott Medical Devices

Vyšetřovatelé

Vrchní vyšetřovatel: Melvin Lobo, MBChB PhD, NIHR Barts Cardiovascular Biomedical Research Unit
Vrchní vyšetřovatel: Stephen Worthley, MB BS PhD, Royal Adelaide Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

17. ledna 2013

Primární dokončení (Aktuální)

1. dubna 2017

Dokončení studie (Aktuální)

27. listopadu 2019

Termíny zápisu do studia

První předloženo

19. září 2012

První předloženo, které splnilo kritéria kontroly kvality

10. října 2012

První zveřejněno (Odhad)

12. října 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

27. května 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. května 2021

Naposledy ověřeno

1. května 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

1201 (1201 XDOZ, local number)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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

Přehled studie

Postavení

Podmínky

Intervence / Léčba

Detailní popis

Typ studie

Zápis (Aktuální)

Kontakty a umístění

Studijní místa

Kritéria účasti

Kritéria způsobilosti

Věk způsobilý ke studiu

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Metoda odběru vzorků

Studijní populace

Popis

Studijní plán

Jak je studie koncipována?

Detaily designu

Počet skupin / kohort

Kohorty a intervence

Skupina / kohorta

Intervence / Léčba

Co je měření studie?

Primární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Sekundární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Spolupracovníci a vyšetřovatelé

Sponzor

Vyšetřovatelé

Termíny studijních záznamů

Hlavní termíny studia

Začátek studia (Aktuální)

Primární dokončení (Aktuální)

Dokončení studie (Aktuální)

Termíny zápisu do studia

První předloženo

První předloženo, které splnilo kritéria kontroly kvality

První zveřejněno (Odhad)

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

Naposledy ověřeno

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?