Trial Outcomes & Findings for Impact of Renal SympAthetic DenerVation on Chronic HypErtension (NCT NCT01628198)

NCT ID: NCT01628198

Last Updated: 2018-01-19

Results Overview

The change in systolic blood pressure as measured by 24 hour ambulatory monitoring at 6 months as compared to from baseline.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: baseline and 6 months
• Results posted on: 2018-01-19

Participant Flow

Participant milestones

Measure	Renal Denervation Group Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Overall Study STARTED	38
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Measure	Renal Denervation Group Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Overall Study Lost to Follow-up	7
Overall Study Withdrawal by Subject	10
Overall Study Screen failure	1

Baseline Characteristics

Impact of Renal SympAthetic DenerVation on Chronic HypErtension

Baseline characteristics by cohort

Measure	Renal Denervation Group n=38 Participants Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Age, Continuous	59.3 years STANDARD_DEVIATION 11.65 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: analysis for participants who returned for follow up

The change in systolic blood pressure as measured by 24 hour ambulatory monitoring at 6 months as compared to from baseline.

Outcome measures

Measure	Renal Denervation Group n=17 Participants Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Mean Change in Ambulatory Systolic Blood Pressure	-10.2 mmHg Standard Deviation 16.4

PRIMARY outcome

Timeframe: baseline and 6 months

Population: analysis for participants who returned for follow up

The change in diastolic blood pressure as measured by 24 hour ambulatory monitoring at 6 months as compared to from baseline.

Outcome measures

Measure	Renal Denervation Group n=17 Participants Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Change in Ambulatory Diastolic Blood Pressure	-5.5 mmHg mean change Standard Deviation 9.8

SECONDARY outcome

Timeframe: baseline, 6 month, 12 months

Population: some participants withdrew from the study, and others were lost to follow up.

Different time points office systolic blood pressure measurements

Outcome measures

Measure	Renal Denervation Group n=38 Participants Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Office Systolic BP Baseline	156.86 mm Hg Standard Deviation 24.3
Office Systolic BP 6 months	151.19 mm Hg Standard Deviation 28.6
Office Systolic BP 12 months	158.45 mm Hg Standard Deviation 27.1

SECONDARY outcome

Timeframe: baseline, 6 month, 12 months

Population: some participants withdrew from the study, and others were lost to follow up.

Different time points office diastolic blood pressure measurements

Outcome measures

Measure	Renal Denervation Group n=38 Participants Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Office Diastolic BP Baseline	87.06 mm Hg Standard Deviation 17.9
Office Diastolic BP 6 months	86.93 mm Hg Standard Deviation 19.3
Office Diastolic BP 12 months	87.75 mm Hg Standard Deviation 14.3

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Some participants withdrew from the study, others were lost to follow up

Renal artery blood flow as measured by Renal Aortic Ratio (RAR) = Peak systolic Velocity renal artery / Peak Systolic Velocity Aorta. A >60% stenosis is reported when there is a >3.5:1 Renal to Aortic Ratio.

Outcome measures

Measure	Renal Denervation Group n=28 Participants Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Renal Aortic Ratio Baseline Left RAR	1.52 ratio Standard Deviation 0.39
Renal Aortic Ratio 12 months Right RAR	1.41 ratio Standard Deviation 0.59
Renal Aortic Ratio 12 months Left RAR	1.52 ratio Standard Deviation 0.53
Renal Aortic Ratio Baseline Right RAR	1.38 ratio Standard Deviation 0.48

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Some participants withdrew from the study, others were lost to follow up

Renal artery blood flow as measured by Resistive Index. RI = (peak systolic velocity - end diastolic velocity ) / peak systolic velocity. the normal value is ~ 0.60, with 0.70 being around the upper limits of normal

Outcome measures

Measure	Renal Denervation Group n=28 Participants Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Resistive Index Baseline Right RI	0.67 index Standard Deviation 0.16
Resistive Index Baseline Left RI	0.72 index Standard Deviation 0.12
Resistive Index 12 months Right RI	0.72 index Standard Deviation 0.08
Resistive Index 12 months Left RI	0.72 index Standard Deviation 0.09

SECONDARY outcome

Timeframe: baseline and 12 months

Population: some participants withdrew from the study, some were lost to follow up

Dimensions of renal artery, right and left

Outcome measures

Measure	Renal Denervation Group n=28 Participants Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Renal Artery Dimensions Baseline R Kidney	11.43 mm Standard Deviation 1.37
Renal Artery Dimensions Baseline L Kidney	11.68 mm Standard Deviation 1.36
Renal Artery Dimensions 12 months R Kidney	11.26 mm Standard Deviation 1.76
Renal Artery Dimensions 12 months L Kidney	11.39 mm Standard Deviation 1.67

SECONDARY outcome

Timeframe: baseline, 6 months, 12 months

Population: some participants withdrew from the study, others were lost to followup

A blood urea nitrogen (BUN) test measures the amount of nitrogen in blood that comes from the waste product urea. Urea is made when protein is broken down in the body. Urea is made in the liver and passed out in the urine.

Outcome measures

Measure	Renal Denervation Group n=38 Participants Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Blood Urea Nitrogen Baseline	20.82 mg/dL Standard Deviation 8.3
Blood Urea Nitrogen 6 months	22.15 mg/dL Standard Deviation 8.49
Blood Urea Nitrogen 12 months	23.11 mg/dL Standard Deviation 15.4

SECONDARY outcome

Timeframe: baseline, 6 months, 12 months

Population: some participants withdrew from the study, others were lost to followup

Creatinine measures the level of the waste product in the body. The amount of creatinine in the blood depends partly on the amount of muscle tissue you have. Men generally have higher creatinine levels than women.Normal levels of creatinine in the blood are approximately 0.6 to 1.2 milligrams (mg) per deciliter (dL) in adult males and 0.5 to 1.1 milligrams per deciliter in adult females. High levels of creatinine indicates kidney impairment.

Outcome measures

Measure	Renal Denervation Group n=38 Participants Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Creatinine Baseline	1.6 mg/dl Standard Deviation 1.8
Creatinine 6 months	1.68 mg/dl Standard Deviation 2.05
Creatinine 12 months	2.03 mg/dl Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months

Population: some participants withdrew from the study, some were lost to follow-up

The total number of anti-hypertensive medications at baseline, 6 months, and 12 months

Outcome measures

Measure	Renal Denervation Group n=38 Participants Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Anti-hypertensive Medications Baseline	5.37 medications Standard Deviation 1.46
Anti-hypertensive Medications 6 months	4.79 medications Standard Deviation 1.29
Anti-hypertensive Medications 12 months	4.64 medications Standard Deviation 1.6

Adverse Events

Renal Denervation Group

Serious events: 18 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Renal Denervation Group n=20 participants at risk Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Cardiac disorders Elevated Blood Pressure or Hypertensive Crisis	40.0% 8/20
Cardiac disorders Atrial Fibrillation	15.0% 3/20
Reproductive system and breast disorders Penumonia and/or sepsis	15.0% 3/20
Renal and urinary disorders Renal Artery Dissection	5.0% 1/20
Nervous system disorders Cerebravascular Accident	5.0% 1/20
Nervous system disorders Transient Ischemic Attack	5.0% 1/20
Cardiac disorders Pericardial Effusion	5.0% 1/20

Other adverse events

Measure	Renal Denervation Group n=20 participants at risk Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter based on physician preference: Saline-Irrigated Radiofrequency Ablation Catheter placed in the renal arteries in a circumferential manner and energy delivered to create 4 burn lesions.
Gastrointestinal disorders Diarrhea	15.0% 3/20
Renal and urinary disorders Right Groin Pain	15.0% 3/20
Cardiac disorders Chest Pain	10.0% 2/20
Cardiac disorders Dyspnea	10.0% 2/20
Cardiac disorders Syncope	10.0% 2/20
Renal and urinary disorders Groin Hematoma	10.0% 2/20
Gastrointestinal disorders Nausea	10.0% 2/20
Gastrointestinal disorders Vomiting	10.0% 2/20
Cardiac disorders Bilateral Lower Extremity Edema	5.0% 1/20
Renal and urinary disorders Urinary Retention	5.0% 1/20
Musculoskeletal and connective tissue disorders Abdominal Discomfort	5.0% 1/20
Renal and urinary disorders Hematuria	5.0% 1/20
Gastrointestinal disorders Difficulty Swallowing	5.0% 1/20
Cardiac disorders Right Femoral Area Pain	5.0% 1/20

Additional Information

Dr. Vivek Y Reddy

Icahn School of Medicine at Mount Sinai

Phone: 212-241-7114

Email: vivek.reddy@mountsinai.org

Results disclosure agreements

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