Trial Outcomes & Findings for EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension (NCT NCT01996033)

NCT ID: NCT01996033

Last Updated: 2019-02-04

Results Overview

Positive number indicates a reduction (improvement) in blood pressure

• Recruitment status: COMPLETED
• Target enrollment: 25 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-02-04

Participant Flow

Participant milestones

Measure	Full Cohort All subjects - this is a single arm study
Overall Study STARTED	25
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Full Cohort All subjects - this is a single arm study
Overall Study Death	1
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	3

Baseline Characteristics

Some subjects were missing baseline data.

Baseline characteristics by cohort

Measure	Full Cohort n=25 Participants All subjects - this is a single arm study
Age, Continuous	64.3 years STANDARD_DEVIATION 10.5 • n=25 Participants
Sex: Female, Male Female	11 Participants n=25 Participants
Sex: Female, Male Male	14 Participants n=25 Participants
Years since HTN diagnosis	19.2 years STANDARD_DEVIATION 15.5 • n=17 Participants • Some subjects were missing baseline data.
Years taking anti-HTN medications	15.4 years STANDARD_DEVIATION 11.3 • n=12 Participants • Some subjects were missing baseline data.
Myocardial Infarction	2 Participants n=25 Participants
Coronary Artery Disease	7 Participants n=25 Participants
Coronary Artery Bypass Graft	3 Participants n=25 Participants
Percutaneous Coronary Intervention	2 Participants n=25 Participants
Cerebrovascular Accident	3 Participants n=25 Participants
Obstructive Sleep Apnea	7 Participants n=25 Participants
Diabetes (Type II)	13 Participants n=25 Participants
Smoker	8 Participants n=25 Participants
Weight	88.0 kilograms STANDARD_DEVIATION 18.7 • n=25 Participants
Height	171.2 centimeters STANDARD_DEVIATION 8.4 • n=25 Participants
BMI	29.9 kilograms/meter2 STANDARD_DEVIATION 5.6 • n=25 Participants
Office Blood Pressure Systolic	164.5 mmHg STANDARD_DEVIATION 20.2 • n=25 Participants
Office Blood Pressure Diastolic	87.8 mmHg STANDARD_DEVIATION 12.6 • n=25 Participants
24Hr Ambulatory Blood Pressure Systolic	157.1 mmHg STANDARD_DEVIATION 18.6 • n=18 Participants • Some subjects were missing baseline data.
24Hr Ambulatory Blood Pressure Diastolic	83.2 mmHg STANDARD_DEVIATION 15.7 • n=18 Participants • Some subjects were missing baseline data.
Serum Creatinine	88.6 micromoles/liter STANDARD_DEVIATION 18.7 • n=25 Participants
Estimated Glomerular Filtration Rate	72.8 mL/min per 1.73m2 STANDARD_DEVIATION 16.1 • n=25 Participants
Number of Antihypertensive Medications	4.7 medications STANDARD_DEVIATION 1.1 • n=25 Participants
Heart Rate	71.2 beats per minute STANDARD_DEVIATION 7.1 • n=22 Participants • Some subjects were missing baseline data.

PRIMARY outcome

Timeframe: 6 months

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

Positive number indicates a reduction (improvement) in blood pressure

Outcome measures

Measure	Full Cohort n=15 Participants All subjects - this is a single arm study
Mean Reduction in Office Systolic Blood Pressure at 6 Months	17.6 mmHg Standard Deviation 21.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Population: Subjects with baseline and follow up data available

Positive number indicates a reduction (improvement) in blood pressure

Outcome measures

Measure	Full Cohort n=15 Participants All subjects - this is a single arm study
Reduction in Office Diastolic Blood Pressure	9.9 mmHg Standard Deviation 11.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Subjects with baseline and follow up data available

Positive number indicates a reduction (improvement) in blood pressure

Outcome measures

Measure	Full Cohort n=14 Participants All subjects - this is a single arm study
Reduction in Office Diastolic Blood Pressure	3.6 mmHg Standard Deviation 17.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Subjects with baseline and follow up data available

Positive number indicates a reduction (improvement) in blood pressure

Outcome measures

Measure	Full Cohort n=14 Participants All subjects - this is a single arm study
Reduction in Office Systolic Blood Pressure	7.0 mmHg Standard Deviation 26.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Subjects with baseline and follow up data available

Positive number indicates a reduction (improvement) in blood pressure

Outcome measures

Measure	Full Cohort n=12 Participants All subjects - this is a single arm study
Reduction in 24 Hour Ambulatory Systolic Blood Pressure	14.6 mmHg Standard Deviation 13.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Subjects with baseline and follow up data available

Positive number indicates a reduction (improvement) in blood pressure

Outcome measures

Measure	Full Cohort n=12 Participants All subjects - this is a single arm study
Reduction in 24 Hour Ambulatory Diastolic Blood Pressure	6.7 mmHg Standard Deviation 10.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Month

Population: Subjects with baseline and follow up data available

Positive number indicates a reduction (improvement) in blood pressure

Outcome measures

Measure	Full Cohort n=20 Participants All subjects - this is a single arm study
Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Population: Subjects with baseline and follow up data available

Positive number indicates a reduction (improvement) in blood pressure

Outcome measures

Measure	Full Cohort n=15 Participants All subjects - this is a single arm study
Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Subjects with baseline and follow up data available

Positive number indicates a reduction (improvement) in blood pressure

Outcome measures

Measure	Full Cohort n=14 Participants All subjects - this is a single arm study
Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Subjects with both baseline and follow up data available

Change from baseline in eGFR

Outcome measures

Measure	Full Cohort n=9 Participants All subjects - this is a single arm study
Change in Estimated Glomerular Filtration Rate (eGFR)	3.8 mL/min per 1.73m2 Standard Deviation 10.8

Adverse Events

Full Cohort

Serious events: 5 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	Full Cohort n=25 participants at risk All subjects - this is a single arm study
Reproductive system and breast disorders Prostate Disease	4.0% 1/25 • Number of events 1
Vascular disorders Arterial Hypertension/Hypertension	4.0% 1/25 • Number of events 2
General disorders Multiple Organ Failure	4.0% 1/25 • Number of events 1
Infections and infestations Pneumonia	4.0% 1/25 • Number of events 1
Blood and lymphatic system disorders Anemia	4.0% 1/25 • Number of events 1
Vascular disorders Hypertensive Crisis	4.0% 1/25 • Number of events 1
Vascular disorders VASC Vessel Stenosis	4.0% 1/25 • Number of events 1
Vascular disorders Hematoma	4.0% 1/25 • Number of events 1

Other adverse events

Measure	Full Cohort n=25 participants at risk All subjects - this is a single arm study
Vascular disorders Arterial Hypertension/Hypertension	8.0% 2/25 • Number of events 2
Hepatobiliary disorders Abnormal Lab Value (Suspicion of Cholangitis)	4.0% 1/25 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pleural Effusion	4.0% 1/25 • Number of events 1
Vascular disorders Renal Artery Stenosis	4.0% 1/25 • Number of events 1

Additional Information

Steven Madej

Abbott

Phone: 651-756-2230

Email: steven.madej@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60