IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN

IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01705080

Acronym

EnligHTN-II

Enrollment

276

Registered

2012-10-12

Start date

2013-01-17

Completion date

2019-11-27

Last updated

2021-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Hypertension

Keywords

Renal Denervation, Renal artery, EnligHTN™ Renal Denervation System, Renal Artery Ablation

Brief summary

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.

Detailed description

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.

Interventions

DEVICEEnligHTN

Renal artery ablation with EnligHTN system used for all groups

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months	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.

Secondary

Measure	Time frame	Description
Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months	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.
Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months	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.
Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure	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.
Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years	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.
Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years	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.
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years	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.
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years	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.
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months	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.
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months	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.
Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months	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.
Percentage of Participants Achieved Office Systolic Blood Pressure < 140 mmHg at 6 Months	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.
Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation	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.
Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation	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.
Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation	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.
Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation	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.
Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation	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.
Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation	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.
Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation	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.
Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation	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.
Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation	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.
Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation	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.
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation	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.
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation	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.
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation	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.
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation	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.
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation	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.
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation	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.
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation	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.
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation	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.
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation	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.
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation	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.

Countries

Australia, France, Germany, Greece, Italy, Netherlands, New Zealand, Norway, Spain, Sweden, United Kingdom

Participant flow

Recruitment details

A total of 276 subjects who underwent renal artery ablation fell into the analysis population of three predefined arms at 33 investigational sites located throughout Europe and Australia. The enrollment began on January 2013 and the last subject was enrolled on 06 September, 2016. The patients last follow-up visit occurred on 27 November, 2019.

Pre-assignment details

Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as unassigned arm. Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.

Participants by arm

Arm	Count
A - EnligHTN for Severe Resistant HTN * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	147
B - EnligHTN for Resistant HTN * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	101
C - EnligHTN for Resistant HTN & CKD * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	28
Total	276

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Death	4	4	6
Overall Study	Missed visit	10	4	1
Overall Study	Withdrawal by Subject	61	44	9

Baseline characteristics

Characteristic	A - EnligHTN for Severe Resistant HTN	Total	C - EnligHTN for Resistant HTN & CKD	B - EnligHTN for Resistant HTN
24-hour ambulatory blood pressure Diastolic	88.9 mmHg STANDARD_DEVIATION 13.1	87.6 mmHg STANDARD_DEVIATION 13.9	82.9 mmHg STANDARD_DEVIATION 15.6	87.0 mmHg STANDARD_DEVIATION 14.4
24-hour ambulatory blood pressure Systolic	159.0 mmHg STANDARD_DEVIATION 16.3	155.0 mmHg STANDARD_DEVIATION 16.3	161.8 mmHg STANDARD_DEVIATION 19.3	147.4 mmHg STANDARD_DEVIATION 12.3
Age, Continuous	61.6 years STANDARD_DEVIATION 10	60.9 years STANDARD_DEVIATION 10.9	68.5 years STANDARD_DEVIATION 8	58.0 years STANDARD_DEVIATION 11.8
Office Blood Pressure Diastolic	97.1 mmHg STANDARD_DEVIATION 16.3	94.3 mmHg STANDARD_DEVIATION 15.2	90.6 mmHg STANDARD_DEVIATION 13.2	91.2 mmHg STANDARD_DEVIATION 13.3
Office Blood Pressure Systolic	180.4 mmHg STANDARD_DEVIATION 22.3	172.9 mmHg STANDARD_DEVIATION 22.6	177.3 mmHg STANDARD_DEVIATION 22.3	160.8 mmHg STANDARD_DEVIATION 17.5
Race and Ethnicity Not Collected	—	0 Participants	—	—
Sex: Female, Male Female	64 Participants	100 Participants	10 Participants	26 Participants
Sex: Female, Male Male	83 Participants	176 Participants	18 Participants	75 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	4 / 147	4 / 101	6 / 28
other Total, other adverse events	40 / 147	26 / 101	9 / 28
serious Total, serious adverse events	72 / 147	38 / 101	18 / 28

Outcome results

Primary

Mean Reduction in Office Systolic Blood Pressure From 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.

Time frame: Baseline to 6 months