Trial Outcomes & Findings for Distal Renal Denervation (NCT NCT02667912)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

55 participants

Primary outcome timeframe

From baseline to 6 months

Results posted on

2021-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	Distal Renal Denervation Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation Endovascular denervation of main trunk of renal artery
Overall Study STARTED	28	27
Overall Study Six Months	27	24
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Distal Renal Denervation Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation Endovascular denervation of main trunk of renal artery
Overall Study Death	3	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Distal Renal Denervation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Distal Renal Denervation n=28 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=27 Participants Endovascular denervation of main trunk of renal artery	Total n=55 Participants Total of all reporting groups
Age, Continuous	56.5 years STANDARD_DEVIATION 9.4 • n=5 Participants	57.3 years STANDARD_DEVIATION 9.5 • n=7 Participants	56.9 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Russia	28 participants n=5 Participants	27 participants n=7 Participants	55 participants n=5 Participants
Concomitant coronary artery disease (CAD)	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Concomitant diabetes	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
A number of antihypertensive drugs taken	4.1 Medication (single active ingredient) STANDARD_DEVIATION 1.1 • n=5 Participants	4.3 Medication (single active ingredient) STANDARD_DEVIATION 0.9 • n=7 Participants	4.2 Medication (single active ingredient) STANDARD_DEVIATION 1.0 • n=5 Participants
A use of diuretics	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Office systolic BP	170.8 mmHg STANDARD_DEVIATION 23.0 • n=5 Participants	169.4 mmHg STANDARD_DEVIATION 23.6 • n=7 Participants	170.1 mmHg STANDARD_DEVIATION 23.1 • n=5 Participants
Office diastolic BP	93.4 mmHg STANDARD_DEVIATION 17.3 • n=5 Participants	94.2 mmHg STANDARD_DEVIATION 19.6 • n=7 Participants	93.8 mmHg STANDARD_DEVIATION 18.3 • n=5 Participants
24-hour systolic BP	168.0 mmHg STANDARD_DEVIATION 24.1 • n=5 Participants	158.0 mmHg STANDARD_DEVIATION 15.2 • n=7 Participants	162.6 mmHg STANDARD_DEVIATION 20.6 • n=5 Participants
24-hour diastolic BP	91.6 mmHg STANDARD_DEVIATION 19.1 • n=5 Participants	88.0 mmHg STANDARD_DEVIATION 19.6 • n=7 Participants	89.6 mmHg STANDARD_DEVIATION 18.2 • n=5 Participants
Left ventricular mass	260.3 g STANDARD_DEVIATION 68.6 • n=5 Participants	259.8 g STANDARD_DEVIATION 84.5 • n=7 Participants	260.1 g STANDARD_DEVIATION 76.1 • n=5 Participants
24-hour proteinuria	0.12 g STANDARD_DEVIATION 0.19 • n=5 Participants	0.16 g STANDARD_DEVIATION 0.30 • n=7 Participants	0.15 g STANDARD_DEVIATION 0.25 • n=5 Participants
Serum creatinine	79.3 mMol/L STANDARD_DEVIATION 24.0 • n=5 Participants	89.4 mMol/L STANDARD_DEVIATION 20.7 • n=7 Participants	84.2 mMol/L STANDARD_DEVIATION 22.8 • n=5 Participants
estimated glomerular filtration rate (eGFR)	79.3 ml/min/m2 STANDARD_DEVIATION 24.0 • n=5 Participants	70.6 ml/min/m2 STANDARD_DEVIATION 13.1 • n=7 Participants	77.3 ml/min/m2 STANDARD_DEVIATION 20.0 • n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 6 months

Population: The subjects who completed 6 months follow up without serious violations of the study protocol - per protocol set

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=27 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=24 Participants Endovascular denervation of main trunk of renal artery
Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)	21.1 mmHg Standard Deviation 19.3	10.3 mmHg Standard Deviation 17.8

SECONDARY outcome

Timeframe: From baseline to 6 months

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=27 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=24 Participants Endovascular denervation of main trunk of renal artery
Number of Adverse Events	1 adverse event	0 adverse event

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: A baseline population except those who refused to continue in the study before final assessment and thereby whose status was unknown at 12 months follow up (5 in the distal denervation arm and 3 patients in conventional denervation arm).

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=23 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=24 Participants Endovascular denervation of main trunk of renal artery
Number of Adverse Events	4 adverse event	2 adverse event

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: Per protocol set (PPS)

Resistance index is calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=25 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=19 Participants Endovascular denervation of main trunk of renal artery
Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Right Segmental Renal Arteries	0.018 ratio Standard Deviation 0.064	0.017 ratio Standard Deviation 0.058

SECONDARY outcome

Timeframe: From baseline to 6 months

Resistance index calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=25 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=19 Participants Endovascular denervation of main trunk of renal artery
Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Left Segmental Renal Arteries	0.006 ratio Standard Deviation 0.066	0.032 ratio Standard Deviation 0.066

SECONDARY outcome

Timeframe: From baseline to 6 months

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=23 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=23 Participants Endovascular denervation of main trunk of renal artery
Changes of Serum Creatinine	2.0 μmol/l Standard Deviation 13.4	2.3 μmol/l Standard Deviation 12.5

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: Intention-to-treat (ITT) analysis by Last Observation Carried Forward (LOCF) method. (Six month data were used in 4 late (\>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (\<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=24 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=24 Participants Endovascular denervation of main trunk of renal artery
Changes of Serum Creatinine	9.8 μmol/l Standard Error 19.7	2.0 μmol/l Standard Error 19.8

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: The subjects with available data

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=28 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=26 Participants Endovascular denervation of main trunk of renal artery
Changes of Estimated Glomerular Filtration Rate (eGFR)	7.6 ml/min/square meter Standard Deviation 13.6	1.3 ml/min/square meter Standard Deviation 12.5

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data. (Six month data were used in 4 late (\>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (\<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=25 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=24 Participants Endovascular denervation of main trunk of renal artery
Changes of Estimated Glomerular Filtration Rate (eGFR)	-7.6 ml/min/square meter Standard Deviation 13.6	-1.3 ml/min/square meter Standard Deviation 12.5

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: PPS

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=27 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=24 Participants Endovascular denervation of main trunk of renal artery
Changes of 24h-mean Diastolic BP	11.1 mmHg Standard Deviation 11.9	7.0 mmHg Standard Deviation 10.6

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data . (Six month data were used in 4 late (\>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (\<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=28 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=26 Participants Endovascular denervation of main trunk of renal artery
Changes of 24h-mean Systolic BP	22.1 mmHg Standard Deviation 20.6	11.5 mmHg Standard Deviation 16.4

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data . (Six month data were used in 4 late (\>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (\<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=28 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=26 Participants Endovascular denervation of main trunk of renal artery
Changes of 24h-mean Diastolic BP	11.2 mmHg Standard Deviation 12.3	7.9 mmHg Standard Deviation 10.6

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: PPS

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=27 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=24 Participants Endovascular denervation of main trunk of renal artery
Changes of Office Systolic BP	26.1 mmHg Standard Deviation 226.8	21.2 mmHg Standard Deviation 23.3

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data . (Six month data were used in 4 late (\>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (\<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=28 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=26 Participants Endovascular denervation of main trunk of renal artery
Changes of Office Systolic BP	12.8 mmHg Standard Deviation 15.7	10.8 mmHg Standard Deviation 18.8

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: PPS

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=27 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=24 Participants Endovascular denervation of main trunk of renal artery
Changes of Office Diastolic BP	12.6 mmHg Standard Deviation 15.6	10.4 mmHg Standard Deviation 12.1

SECONDARY outcome

Timeframe: From baseline to 12 months

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=28 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=26 Participants Endovascular denervation of main trunk of renal artery
Changes of Office Diastolic BP	12.8 mmHg Standard Deviation 15.7	10.8 mmHg Standard Deviation 18.8

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: PPS

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=26 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=24 Participants Endovascular denervation of main trunk of renal artery
Changes of Daytime Systolic BP	22.2 mmHg Standard Deviation 19.9	10.9 mmHg Standard Deviation 18.9

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: ITT analysis by Last Observation Carried Forward (LOCF) method. (Six month data were used in 4 late (\>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (\<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=28 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=26 Participants Endovascular denervation of main trunk of renal artery
Changes of Daytime Mean Systolic BP	22.1 mmHg Standard Deviation 20.5	11.5 mmHg Standard Deviation 18.6

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: PPS

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=26 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=24 Participants Endovascular denervation of main trunk of renal artery
Changes of Daytime Mean Diastolic BP	11.8 mmHg Standard Deviation 12.9	10.9 mmHg Standard Deviation 18.9

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: ITT analysis by Last Observation Carried Forward (LOCF). (Six month data were used in 4 late (\>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (\<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=28 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=26 Participants Endovascular denervation of main trunk of renal artery
Changes of Daytime Mean Diastolic BP	11.3 mmHg Standard Deviation 12.6	7.9 mmHg Standard Deviation 12.3

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: PPS

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=26 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=24 Participants Endovascular denervation of main trunk of renal artery
Changes of Nighttime Mean Systolic BP	16.5 mmHg Standard Deviation 19.7	9.3 mmHg Standard Deviation 20.9

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data. (Six month data were used in 4 late (\>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (\<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=27 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=26 Participants Endovascular denervation of main trunk of renal artery
Changes of Nighttime Mean Systolic BP	17.8 mmHg Standard Deviation 22.0	10.9 mmHg Standard Deviation 19.2

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: PPS

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=26 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=24 Participants Endovascular denervation of main trunk of renal artery
Changes of Nighttime Mean Diastolic BP	6.7 mmHg Standard Deviation 12.8	6.5 mmHg Standard Deviation 11.8

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data. (6 month data were used in 4 late (\>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (\<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)

Outcome measures

Outcome measures
Measure	Distal Renal Denervation n=27 Participants Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=26 Participants Endovascular denervation of main trunk of renal artery
Changes of Nighttime Mean Diastolic BP	7.2 mmHg Standard Deviation 12.5	7.5 mmHg Standard Deviation 12.1

Adverse Events

Distal Renal Denervation

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Renal Denervation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Distal Renal Denervation n=27 participants at risk Endovascular denervation of segmental branches of renal artery	Conventional Renal Denervation n=24 participants at risk Endovascular denervation of main trunk of renal artery
Surgical and medical procedures Post-punctional pseudoaneuryzm	3.7% 1/27 • Number of events 1 • 6 months Serious Adverse Events	0.00% 0/24 • 6 months Serious Adverse Events

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stanislav Pekarskiy

Tomsk National Research Medical Center of the Russian Academy of Sciences

Phone: +73822558122

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place