EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01996033
• Collaborator: (none)
• Enrollment: 25
• Locations: 12
• Duration (Months): 39
• Patients Per Site: 2.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension in clinical routine practice.

Condition or Disease	Intervention/Treatment	Phase
Uncontrolled Hypertension

Detailed Description

This is a post market, multi-center, open label, observational study. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located in Germany and will be followed for 1 year post procedure.The expected duration of the investigation will be approximately 4 years.

Study Design

• Study Type: Observational
• Actual Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: This is a Post Market, Multi-center, Open Label, Observational Study. Approximately 500 Subjects With Uncontrolled Hypertension Will Undergo Renal Artery Ablation
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Outcome Measures

Primary Outcome Measures

1. Mean Reduction in Office Systolic Blood Pressure at 6 Months [6 months]

   Positive number indicates a reduction (improvement) in blood pressure

Other Outcome Measures

1. Reduction in Office Diastolic Blood Pressure [6 Months]

   Positive number indicates a reduction (improvement) in blood pressure

2. Reduction in Office Diastolic Blood Pressure [12 Months]

   Positive number indicates a reduction (improvement) in blood pressure

3. Reduction in Office Systolic Blood Pressure [12 Months]

   Positive number indicates a reduction (improvement) in blood pressure

4. Reduction in 24 Hour Ambulatory Systolic Blood Pressure [12 Months]

   Positive number indicates a reduction (improvement) in blood pressure

5. Reduction in 24 Hour Ambulatory Diastolic Blood Pressure [12 Months]

   Positive number indicates a reduction (improvement) in blood pressure

6. Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure [1 Month]

   Positive number indicates a reduction (improvement) in blood pressure

7. Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure [6 Months]

   Positive number indicates a reduction (improvement) in blood pressure

8. Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure [12 Months]

   Positive number indicates a reduction (improvement) in blood pressure

9. Change in Estimated Glomerular Filtration Rate (eGFR) [12 Months]

   Change from baseline in eGFR

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is planned to undergo a renal denervation procedure for the treatment of hypertension

• 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 (SBP) ≥ 140 mmHg

• Subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE-I/ Angiotensin Receptor Blocker (ARB), Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs

Exclusion Criteria:

• Subject has known 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 a history of hemodynamically significant valvular heart disease

• Subject has blood clotting abnormalities

• Subject life expectancy is < 12 months, as determined by the Study Investigator

• Subject is participating in another clinical study which has the potential

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kliniken Villingen-Schwenningen	Villingen-Schwenningen	Baden-Wurttemberg	Germany	78052
2	Kliniken Oberallgäu gGmbH Klinik Immenstadt	Immenstadt	Bayern	Germany	87509
3	Immanuelklinikum Bernau und Herzzentrum Brandenburg	Bernau	Brandenburg	Germany	16321
4	Klinikum Ernst von Bergmann	Potsdam	Brandenburg	Germany	14467
5	Asklepios Schwalm-Eder-Kliniken GmbH	Schwalmstadt	Hesse	Germany	34613
6	Klinikum Oldenburg gGmbH	Oldenburg	Niedersachsen	Germany	26133
7	Elisabeth-Krankenhaus Essen	Essen	Nordrhein-Westfalen	Germany	45138
8	Medizinische Einrichtungen der Universität Düsseldorf	Düsseldorf	Northrhine-Westphalia	Germany	40225
9	Kardiologische Praxis Wuppertal	Wuppertal	Northrhine-Westphalia	Germany	42103
10	Universitätsklinikum Leipzig	Leipzig	Saxony	Germany	04103
11	Augusta-Krankenhaus Düsseldorf	Düsseldorf		Germany	40472
12	Diakonie-Klinikum Schwäbisch Hall gGmbH	Schwäbisch Hall		Germany	74523

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Christoph K Naber, MD, Elisabeth-Krankenhaus Essen, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01996033
• Other Study ID Numbers: CV-12-064-GE-HT
• First Posted: Nov 27, 2013
• Last Update Posted: Feb 4, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Abbott Medical Devices: uncontrolled hypertension; Renal Denervation
• Additional relevant MeSH terms: Hypertension

Study Results

Participant Flow

Arm/Group Title	Full Cohort
Arm/Group Description	All subjects - this is a single arm study
Period Title: Overall Study
STARTED	25
COMPLETED	16
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	Full Cohort
Arm/Group Description	All subjects - this is a single arm study
Overall Participants	25
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.3 (10.5)
Sex: Female, Male (Count of Participants)
Female	11 44%
Male	14 56%
Years since HTN diagnosis (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.2 (15.5)
Years taking anti-HTN medications (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.4 (11.3)
Myocardial Infarction (Count of Participants)
Count of Participants [Participants]	2 8%
Coronary Artery Disease (Count of Participants)
Count of Participants [Participants]	7 28%
Coronary Artery Bypass Graft (Count of Participants)
Count of Participants [Participants]	3 12%
Percutaneous Coronary Intervention (Count of Participants)
Count of Participants [Participants]	2 8%
Cerebrovascular Accident (Count of Participants)
Count of Participants [Participants]	3 12%
Obstructive Sleep Apnea (Count of Participants)
Count of Participants [Participants]	7 28%
Diabetes (Type II) (Count of Participants)
Count of Participants [Participants]	13 52%
Smoker (Count of Participants)
Count of Participants [Participants]	8 32%
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	88.0 (18.7)
Height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	171.2 (8.4)
BMI (kilograms/meter2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms/meter2]	29.9 (5.6)
Office Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Systolic	164.5 (20.2)
Diastolic	87.8 (12.6)
24Hr Ambulatory Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Systolic	157.1 (18.6)
Diastolic	83.2 (15.7)
Serum Creatinine (micromoles/liter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [micromoles/liter]	88.6 (18.7)
Estimated Glomerular Filtration Rate (mL/min per 1.73m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL/min per 1.73m2]	72.8 (16.1)
Number of Antihypertensive Medications (medications) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [medications]	4.7 (1.1)
Heart Rate (beats per minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [beats per minute]	71.2 (7.1)

Outcome Measures

1. Primary Outcome

Title	Mean Reduction in Office Systolic Blood Pressure at 6 Months
Description	Positive number indicates a reduction (improvement) in blood pressure
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All subjects with data available at baseline and 6-month follow up

Arm/Group Title	Full Cohort
Arm/Group Description	All subjects - this is a single arm study
Measure Participants	15
Mean (Standard Deviation) [mmHg]	17.6 (21.5)

2. Other Pre-specified Outcome

Title	Reduction in Office Diastolic Blood Pressure
Description	Positive number indicates a reduction (improvement) in blood pressure
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Subjects with baseline and follow up data available

Arm/Group Title	Full Cohort
Arm/Group Description	All subjects - this is a single arm study
Measure Participants	15
Mean (Standard Deviation) [mmHg]	9.9 (11.9)

3. Other Pre-specified Outcome

Title	Reduction in Office Diastolic Blood Pressure
Description	Positive number indicates a reduction (improvement) in blood pressure
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Subjects with baseline and follow up data available

Arm/Group Title	Full Cohort
Arm/Group Description	All subjects - this is a single arm study
Measure Participants	14
Mean (Standard Deviation) [mmHg]	3.6 (17.3)

4. Other Pre-specified Outcome

Title	Reduction in Office Systolic Blood Pressure
Description	Positive number indicates a reduction (improvement) in blood pressure
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Subjects with baseline and follow up data available

Arm/Group Title	Full Cohort
Arm/Group Description	All subjects - this is a single arm study
Measure Participants	14
Mean (Standard Deviation) [mmHg]	7.0 (26.0)

5. Other Pre-specified Outcome

Title	Reduction in 24 Hour Ambulatory Systolic Blood Pressure
Description	Positive number indicates a reduction (improvement) in blood pressure
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Subjects with baseline and follow up data available

Arm/Group Title	Full Cohort
Arm/Group Description	All subjects - this is a single arm study
Measure Participants	12
Mean (Standard Deviation) [mmHg]	14.6 (13.7)

6. Other Pre-specified Outcome

Title	Reduction in 24 Hour Ambulatory Diastolic Blood Pressure
Description	Positive number indicates a reduction (improvement) in blood pressure
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Subjects with baseline and follow up data available

Arm/Group Title	Full Cohort
Arm/Group Description	All subjects - this is a single arm study
Measure Participants	12
Mean (Standard Deviation) [mmHg]	6.7 (10.1)

7. Other Pre-specified Outcome

Title	Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure
Description	Positive number indicates a reduction (improvement) in blood pressure
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

Subjects with baseline and follow up data available

Arm/Group Title	Full Cohort
Arm/Group Description	All subjects - this is a single arm study
Measure Participants	20
Count of Participants [Participants]	8 32%

8. Other Pre-specified Outcome

Title	Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure
Description	Positive number indicates a reduction (improvement) in blood pressure
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Subjects with baseline and follow up data available

Arm/Group Title	Full Cohort
Arm/Group Description	All subjects - this is a single arm study
Measure Participants	15
Count of Participants [Participants]	6 24%

9. Other Pre-specified Outcome

Title	Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure
Description	Positive number indicates a reduction (improvement) in blood pressure
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Subjects with baseline and follow up data available

Arm/Group Title	Full Cohort
Arm/Group Description	All subjects - this is a single arm study
Measure Participants	14
Count of Participants [Participants]	3 12%

10. Other Pre-specified Outcome

Title	Change in Estimated Glomerular Filtration Rate (eGFR)
Description	Change from baseline in eGFR
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Subjects with both baseline and follow up data available

Arm/Group Title	Full Cohort
Arm/Group Description	All subjects - this is a single arm study
Measure Participants	9
Mean (Standard Deviation) [mL/min per 1.73m2]	3.8 (10.8)

Adverse Events

Arm/Group Title	Full Cohort
Arm/Group Description	All subjects - this is a single arm study
All Cause Mortality
	Full Cohort
	Affected / at Risk (%)	# Events
Total	1/25 (4%)
Serious Adverse Events
	Full Cohort
	Affected / at Risk (%)	# Events
Total	5/25 (20%)
Blood and lymphatic system disorders
Anemia	1/25 (4%)	1
General disorders
Multiple Organ Failure	1/25 (4%)	1
Infections and infestations
Pneumonia	1/25 (4%)	1
Reproductive system and breast disorders
Prostate Disease	1/25 (4%)	1
Vascular disorders
Arterial Hypertension/Hypertension	1/25 (4%)	2
Hypertensive Crisis	1/25 (4%)	1
VASC Vessel Stenosis	1/25 (4%)	1
Hematoma	1/25 (4%)	1
Other (Not Including Serious) Adverse Events
	Full Cohort
	Affected / at Risk (%)	# Events
Total	4/25 (16%)
Hepatobiliary disorders
Abnormal Lab Value (Suspicion of Cholangitis)	1/25 (4%)	1
Respiratory, thoracic and mediastinal disorders
Pleural Effusion	1/25 (4%)	1
Vascular disorders
Arterial Hypertension/Hypertension	2/25 (8%)	2
Renal Artery Stenosis	1/25 (4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.