IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN (EnligHTN-II)
4 de mayo de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
276
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bad Krozingen, Alemania, 79189
- Universitäts-Herzzentrum Freiburg - Bad Krozingen
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Berlin, Alemania, 13347
- Jüdisches Krankenhaus Berlin
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Essen, Alemania, 45122
- Universitatsklinikum Essen (Aor)
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Homburg, Alemania, 66421
- Universitatsklinikum des Saarlandes
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Mainz, Alemania, 55131
- Klinikum der Johannes-Gutenberg-Universität
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Trier, Alemania, 54292
- Krankenhaus der Barmherzigen Brüder
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Bavaria
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Coburg, Bavaria, Alemania, 96450
- Klinikum Coburg GmbH
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Ingolstadt, Bavaria, Alemania, 85049
- Klinikum Ingolstadt GmbH
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Hesse
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Bad Nauheim, Hesse, Alemania, 61231
- Kerckhoff-Klinik gGmbH
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Nordrhein Westfalen
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Bad Oeynhausen, Nordrhein Westfalen, Alemania, 32545
- Herz-und Diabetes Zentrum NRW
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Saxony
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Leipzig, Saxony, Alemania, 4103
- Uni-Klinik Leipzig, Intervent. Angiologie
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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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Basque
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San Sebastián, Basque, España, 20014
- Hospital Universitario Donostia
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Lyon, Francia, 69317
- Hôpital de La Croix Rousse
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St. Etienne, Francia
- St-Etienne CHU
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Strasbourg, Francia, 67091
- Hopital Civil - Universitaires de Strasbourg
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Franche-Comte
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Besancon, Franche-Comte, Francia, 25030
- CHU de Besançon - Jean Minjoz
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Massy
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Paris, Massy, Francia
- Institute Cardio. Paris-Sud-Institut Jacques Cartier
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Athens, Grecia
- 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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Bergen, Noruega
- Haukeland Universitetssykehus
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Trondheim, Noruega, 7006
- St. Olavs University Hospital
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Dunedin, Nueva Zelanda, 9016
- Dunedin Public Hospital
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Den Haag, Países Bajos, 2545 CH
- Haga Ziekenhuis Locatie Leyenburg
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Utrecht, Países Bajos, 3584 CX
- UMC Utrecht
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London, Reino Unido, EC1M 6BQ
- NIHR Barts Cardiovascular Biomedical Research Unit
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Sheffield, Reino Unido, S5 7AU
- Northern General Hospital
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Goteborg, Suecia, S41345
- Sahlgrenska University Hospital Gothenburg
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Subjects with uncontrolled hypertension
Descripción
Inclusion Criteria:
- Subject is ≥ 18 years of age at time of consent
- Subject must be able and willing to provide written informed consent
- Subject must be able and willing to comply with the required follow-up schedule
- Subject has office Systolic Blood Pressure ≥ 140 mmHg at confirmatory visit
- Subject has a daytime mean Systolic Ambulatory Blood Pressure > 135 mmHg within 90 days prior to procedure
- Subject has established hypertension (diagnosed ≥12 month prior to baseline) and is on a guideline based drug regimen at a stable and fully tolerated dose consisting of ≥ 3 anti-hypertensive medications (including 1 diuretic) or subject has a documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
Exclusion Criteria:
- Subject has significant renovascular abnormalities such as renal artery stenosis > 30%
- Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
- Subject has hemodynamically significant valvular heart disease as determined by study investigator
- Subject has a life expectancy less than 12 months, as determined by the Investigator
- Subject is participating in another clinical study which has the potential to impact their hypertension management (pharmaceutical/device/homeopathic)
- Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
- Subject has active systemic infection
- Subject has renal arteries with diameter(s) < 4 mm in diameter
- Subject has an estimated GFR <15 mL/min per 1.73 m^2 using the MDRD formula
- Subject had a renal transplant or is awaiting a renal transplant
- Subject has blood clotting abnormalities
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months
Periodo de tiempo: Baseline to 6 months
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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.
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Baseline to 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure
Periodo de tiempo: 30 days post procedure
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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
Periodo de tiempo: 6 months
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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
Periodo de tiempo: Confirmatory visit to 6 months
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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
Periodo de tiempo: 2 years
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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
Periodo de tiempo: 5 years
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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
Periodo de tiempo: Confirmatory visit to 2 years
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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
Periodo de tiempo: Confirmatory visit to 5 years
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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
Periodo de tiempo: Baseline to 6 months
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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.
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Baseline to 6 months
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Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months
Periodo de tiempo: Baseline to 6 months
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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.
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Baseline to 6 months
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Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months
Periodo de tiempo: Baseline to 6 months
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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.
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Baseline to 6 months
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Percentage of Participants Achieved Office Systolic Blood Pressure < 140 mmHg at 6 Months
Periodo de tiempo: 6 months
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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.
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6 months
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Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation
Periodo de tiempo: Baseline to 1 year
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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.
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Baseline to 1 year
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Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation
Periodo de tiempo: Baseline to 2 years
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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.
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Baseline to 2 years
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Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation
Periodo de tiempo: Baseline to 3 years
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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.
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Baseline to 3 years
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Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation
Periodo de tiempo: Baseline to 4 years
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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.
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Baseline to 4 years
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Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation
Periodo de tiempo: Baseline to 5 years
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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.
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Baseline to 5 years
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Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation
Periodo de tiempo: Baseline to 1 year
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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.
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Baseline to 1 year
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Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
Periodo de tiempo: Baseline to 2 years
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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.
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Baseline to 2 years
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Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
Periodo de tiempo: Baseline to 3 years
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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.
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Baseline to 3 years
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Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
Periodo de tiempo: 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.
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Baseline to 4 years
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Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
Periodo de tiempo: 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.
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Baseline to 5 years
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Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation
Periodo de tiempo: 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.
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Baseline to 1 year
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Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation
Periodo de tiempo: 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.
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Baseline to 2 years
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Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation
Periodo de tiempo: 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.
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Baseline to 3 years
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Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation
Periodo de tiempo: 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.
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Baseline to 4 years
|
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Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
Periodo de tiempo: 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.
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Baseline to 2 years
|
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Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
Periodo de tiempo: 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.
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Baseline to 3 years
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Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
Periodo de tiempo: 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.
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Baseline to 4 years
|
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Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Melvin Lobo, MBChB PhD, NIHR Barts Cardiovascular Biomedical Research Unit
- Investigador principal: Stephen Worthley, MB BS PhD, Royal Adelaide Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de enero de 2013
Finalización primaria (Actual)
1 de abril de 2017
Finalización del estudio (Actual)
27 de noviembre de 2019
Fechas de registro del estudio
Enviado por primera vez
19 de septiembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
10 de octubre de 2012
Publicado por primera vez (Estimar)
12 de octubre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de mayo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
4 de mayo de 2021
Última verificación
1 de mayo de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1201 (1201 XDOZ, local number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .