Trial Outcomes & Findings for Renal Denervation for Management of Drug-Resistant Hypertension (NCT NCT01505010)
NCT ID: NCT01505010
Last Updated: 2020-03-27
Results Overview
The primary endpoint deals with efficacy of renal denervation with regard to controlling blood pressure on ambulatory measurement. It consists of the baseline-adjusted between-group difference in the changes in 24-h systolic blood pressure. Because automated blood pressure monitors will be used, the assessment of the primary endpoint is blind.
COMPLETED
NA
17 participants
The primary endpoint has been assessed 6 months after randomization.
2020-03-27
Participant Flow
From 28 March 2014 until 11 May 2016, 3 Belgian centers screened 29 patients, of whom 4 did not meet the criteria to enter the run-in period. Of 25 remaining patients, 8 were not eligible for randomization. Of 17 eligible patients, 9 were randomized to control and 8 to RDN. Of the 8 patients randomized to intervention, two did not undergo RDN.
Participant milestones
| Measure |
Control Group
Standard antihypertensive drug treatment
|
Intervention Group
Renal denervation plus standard antihypertensive drug treatment
Renal denervation: Renal denervation in the intervention group
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Control Group
Standard antihypertensive drug treatment
|
Intervention Group
Renal denervation plus standard antihypertensive drug treatment
Renal denervation: Renal denervation in the intervention group
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=9 Participants
Standard antihypertensive drug treatment
Renal denervation: Renal denervation in the intervention group
|
Intervention Group
n=6 Participants
Renal denervation plus standard antihypertensive drug treatment
Renal denervation: Renal denervation in the intervention group
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 8.8 • n=9 Participants
|
48.4 years
STANDARD_DEVIATION 10.8 • n=6 Participants
|
48.1 years
STANDARD_DEVIATION 9.3 • n=15 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
8 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
7 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
9 participants
n=9 Participants
|
6 participants
n=6 Participants
|
15 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: The primary endpoint has been assessed 6 months after randomization.The primary endpoint deals with efficacy of renal denervation with regard to controlling blood pressure on ambulatory measurement. It consists of the baseline-adjusted between-group difference in the changes in 24-h systolic blood pressure. Because automated blood pressure monitors will be used, the assessment of the primary endpoint is blind.
Outcome measures
| Measure |
Control Group
n=9 Participants
Standard antihypertensive drug treatment
|
Intervention Group
n=6 Participants
Renal denervation plus standard antihypertensive drug treatment
Renal denervation: Renal denervation in the intervention group
|
|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement)
|
0.7 mmHg
Interval -12.0 to 13.4
|
-21.7 mmHg
Interval -33.4 to -9.9
|
PRIMARY outcome
Timeframe: This endpoint has been assessed 6 months after randomization.The primary endpoint for safety of renal denervation is the baseline-adjusted between group difference in the change of glomerular filtration rate estimated by using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.
Outcome measures
| Measure |
Control Group
n=9 Participants
Standard antihypertensive drug treatment
|
Intervention Group
n=6 Participants
Renal denervation plus standard antihypertensive drug treatment
Renal denervation: Renal denervation in the intervention group
|
|---|---|---|
|
Change in Glomerular Filtration Rate
|
81.6 ml/min/1.73 m2
Standard Deviation 24.1
|
92.4 ml/min/1.73 m2
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: This endpoint will be assessed 6 months after randomization.The number and doses of blood-pressure lowering drugs in the 2 arms of the trial.
Outcome measures
| Measure |
Control Group
n=9 Participants
Standard antihypertensive drug treatment
|
Intervention Group
n=6 Participants
Renal denervation plus standard antihypertensive drug treatment
Renal denervation: Renal denervation in the intervention group
|
|---|---|---|
|
The Intensity of Medical Treatment
|
4 number of drugs taken per day
Interval 4.0 to 6.0
|
3 number of drugs taken per day
Interval 2.0 to 4.0
|
Adverse Events
Control Group
Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place