IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN (EnligHTN-II)
4. maj 2021 opdateret af: 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.
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
Tilmelding
276
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Chermside, Australien, 4032
- The Prince Charles Hospital
-
Parkville, Australien, 3050
- Royal Melbourne Hospital - City Campus
-
Perth, Australien, 6000
- Royal Perth Hospital
-
-
South Australia
-
Adelaide, South Australia, Australien, 5000
- Royal Adelaide Hospital
-
-
-
-
-
London, Det Forenede Kongerige, EC1M 6BQ
- NIHR Barts Cardiovascular Biomedical Research Unit
-
Sheffield, Det Forenede Kongerige, S5 7AU
- Northern General Hospital
-
-
-
-
-
Lyon, Frankrig, 69317
- Hôpital de La Croix Rousse
-
St. Etienne, Frankrig
- St-Etienne CHU
-
Strasbourg, Frankrig, 67091
- Hopital Civil - Universitaires de Strasbourg
-
-
Franche-Comte
-
Besancon, Franche-Comte, Frankrig, 25030
- CHU de Besançon - Jean Minjoz
-
-
Massy
-
Paris, Massy, Frankrig
- Institute Cardio. Paris-Sud-Institut Jacques Cartier
-
-
-
-
-
Athens, Grækenland
- University of Athens, Ippocration Hospital
-
-
-
-
-
Den Haag, Holland, 2545 CH
- Haga Ziekenhuis Locatie Leyenburg
-
Utrecht, Holland, 3584 CX
- UMC Utrecht
-
-
-
-
-
Bologna, Italien, 40138
- Policlinico S.Orsola Malpighi
-
Milano, Italien, 20138
- Centro Cardiologico Monzino
-
-
Tuscany
-
Massa, Tuscany, Italien, 54100
- Fondazione Toscana Gabriele Monasterio CNR
-
-
-
-
-
Dunedin, New Zealand, 9016
- Dunedin Public Hospital
-
-
-
-
-
Bergen, Norge
- Haukeland Universitetssykehus
-
Trondheim, Norge, 7006
- St. Olavs University Hospital
-
-
-
-
Basque
-
San Sebastián, Basque, Spanien, 20014
- Hospital Universitario Donostia
-
-
-
-
-
Goteborg, Sverige, S41345
- Sahlgrenska University Hospital Gothenburg
-
-
-
-
-
Bad Krozingen, Tyskland, 79189
- Universitäts-Herzzentrum Freiburg - Bad Krozingen
-
Berlin, Tyskland, 13347
- Jüdisches Krankenhaus Berlin
-
Essen, Tyskland, 45122
- Universitatsklinikum Essen (Aor)
-
Homburg, Tyskland, 66421
- Universitatsklinikum des Saarlandes
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Mainz, Tyskland, 55131
- Klinikum der Johannes-Gutenberg-Universität
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Trier, Tyskland, 54292
- Krankenhaus der Barmherzigen Brüder
-
-
Bavaria
-
Coburg, Bavaria, Tyskland, 96450
- Klinikum Coburg GmbH
-
Ingolstadt, Bavaria, Tyskland, 85049
- Klinikum Ingolstadt GmbH
-
-
Hesse
-
Bad Nauheim, Hesse, Tyskland, 61231
- Kerckhoff-Klinik gGmbH
-
-
Nordrhein Westfalen
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Bad Oeynhausen, Nordrhein Westfalen, Tyskland, 32545
- Herz-und Diabetes Zentrum NRW
-
-
Saxony
-
Leipzig, Saxony, Tyskland, 4103
- Uni-Klinik Leipzig, Intervent. Angiologie
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Antal grupper/kohorter
3
Kohorter og interventioner
Gruppe / kohorteGruppe / kohorte |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
A - EnligHTN for Severe Resistant HTN
|
Renal artery ablation with EnligHTN system used for all groups
|
|
B - EnligHTN for Resistant HTN
|
Renal artery ablation with EnligHTN system used for all groups
|
|
C - EnligHTN for Resistant HTN & CKD
|
Renal artery ablation with EnligHTN system used for all groups
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
|
30 days post procedure
|
|
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.
|
6 months
|
|
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.
|
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
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.
|
2 years
|
|
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.
|
5 years
|
|
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.
|
Confirmatory visit to 2 years
|
|
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.
|
Confirmatory visit to 5 years
|
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Ledende efterforsker: Melvin Lobo, MBChB PhD, NIHR Barts Cardiovascular Biomedical Research Unit
- Ledende efterforsker: Stephen Worthley, MB BS PhD, Royal Adelaide Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
17. januar 2013
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
1. april 2017
Studieafslutning (Faktiske)
Studieafslutning
27. november 2019
Datoer for studieregistrering
Først indsendt
Først indsendt
19. september 2012
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
10. oktober 2012
Først opslået (Skøn)
Først opslået
12. oktober 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
27. maj 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. maj 2021
Sidst verificeret
Sidst verificeret
1. maj 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 1201 (1201 XDOZ, local number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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