- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01705080
IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN (EnligHTN-II)
4. mai 2021 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
276
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Chermside, Australia, 4032
- The Prince Charles Hospital
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Parkville, Australia, 3050
- Royal Melbourne Hospital - City Campus
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Perth, Australia, 6000
- Royal Perth Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Lyon, Frankrike, 69317
- Hopital de la Croix Rousse
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St. Etienne, Frankrike
- St-Etienne CHU
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Strasbourg, Frankrike, 67091
- Hopital Civil - Universitaires de Strasbourg
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Franche-Comte
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Besancon, Franche-Comte, Frankrike, 25030
- CHU de Besançon - Jean Minjoz
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Massy
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Paris, Massy, Frankrike
- Institute Cardio. Paris-Sud-Institut Jacques Cartier
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Athens, Hellas
- University of Athens, Ippocration Hospital
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Bologna, Italia, 40138
- Policlinico S.Orsola Malpighi
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Milano, Italia, 20138
- Centro Cardiologico Monzino
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Tuscany
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Massa, Tuscany, Italia, 54100
- Fondazione Toscana Gabriele Monasterio CNR
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Den Haag, Nederland, 2545 CH
- Haga Ziekenhuis Locatie Leyenburg
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Utrecht, Nederland, 3584 CX
- UMC Utrecht
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Dunedin, New Zealand, 9016
- Dunedin Public Hospital
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Bergen, Norge
- Haukeland Universitetssykehus
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Trondheim, Norge, 7006
- St. Olavs University Hospital
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Basque
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San Sebastián, Basque, Spania, 20014
- Hospital Universitario Donostia
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London, Storbritannia, EC1M 6BQ
- NIHR Barts Cardiovascular Biomedical Research Unit
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Sheffield, Storbritannia, S5 7AU
- Northern General Hospital
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Goteborg, Sverige, S41345
- Sahlgrenska University Hospital Gothenburg
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Bad Krozingen, Tyskland, 79189
- Universitäts-Herzzentrum Freiburg - Bad Krozingen
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Berlin, Tyskland, 13347
- Jüdisches Krankenhaus Berlin
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Essen, Tyskland, 45122
- Universitätsklinikum Essen (AöR)
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Homburg, Tyskland, 66421
- Universitätsklinikum des Saarlandes
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Mainz, Tyskland, 55131
- Klinikum der Johannes-Gutenberg-Universitat
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Trier, Tyskland, 54292
- Krankenhaus der Barmherzigen Brüder
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Bavaria
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Coburg, Bavaria, Tyskland, 96450
- Klinikum Coburg GmbH
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Ingolstadt, Bavaria, Tyskland, 85049
- Klinikum Ingolstadt GmbH
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Hesse
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Bad Nauheim, Hesse, Tyskland, 61231
- Kerckhoff-Klinik gGmbH
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Nordrhein Westfalen
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Bad Oeynhausen, Nordrhein Westfalen, Tyskland, 32545
- Herz-und Diabetes Zentrum NRW
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Saxony
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Leipzig, Saxony, Tyskland, 4103
- Uni-Klinik Leipzig, Intervent. Angiologie
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Subjects with uncontrolled hypertension
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
A - EnligHTN for Severe Resistant HTN
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Renal artery ablation with EnligHTN system used for all groups
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B - EnligHTN for Resistant HTN
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Renal artery ablation with EnligHTN system used for all groups
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C - EnligHTN for Resistant HTN & CKD
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Renal artery ablation with EnligHTN system used for all groups
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure
Tidsramme: 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.
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30 days post procedure
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Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months
Tidsramme: 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.
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6 months
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Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months
Tidsramme: 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.
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Confirmatory visit to 6 months
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Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years
Tidsramme: 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.
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2 years
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Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years
Tidsramme: 5 years
|
The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm.
Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
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5 years
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Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years
Tidsramme: Confirmatory visit to 2 years
|
Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
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Confirmatory visit to 2 years
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Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years
Tidsramme: Confirmatory visit to 5 years
|
Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
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Confirmatory visit to 5 years
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Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Melvin Lobo, MBChB PhD, NIHR Barts Cardiovascular Biomedical Research Unit
- Hovedetterforsker: Stephen Worthley, MB BS PhD, Royal Adelaide Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
17. januar 2013
Primær fullføring (Faktiske)
1. april 2017
Studiet fullført (Faktiske)
27. november 2019
Datoer for studieregistrering
Først innsendt
19. september 2012
Først innsendt som oppfylte QC-kriteriene
10. oktober 2012
Først lagt ut (Anslag)
12. oktober 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. mai 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. mai 2021
Sist bekreftet
1. mai 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1201 (1201 XDOZ, local number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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PD Dr. Grégoire WuerznerSwiss National Science FoundationFullførtHypertensjon | Overvekt | White Coat Hypertension | Resistent hypertensjonSveits
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University Hospital, ToursFullførtPTFE-dekkede stenter versus nakne stenter i TIPS (Transjugulær Intra-hepatisk Porto-systemisk shunt)Cirrhotic Portal HypertensionFrankrike
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Sun Yat-sen UniversityFullførtHepatocellulært karsinom (HCC) | Cirrhotic Portal HypertensionKina
Kliniske studier på EnligHTN
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University of AdelaideUkjent
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Abbott Medical DevicesFullførtHypertensjon | Renal denerveringNew Zealand, Australia
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Institute Arnault Tzanck, FranceAbbott Medical DevicesUkjentKronisk hjertesviktFrankrike
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University Hospital, SaarlandUkjentHjertefeil | Hypertensjon | Diabetes | Kronisk nyre sykdom | HjerterytmeforstyrrelserTyskland