N/A N=55 Randomized Triple-blind Treatment

Distal Renal Denervation

Hypertension, Resistant to Conventional Therapy

Bottom Line

View on ClinicalTrials.gov: NCT02667912 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Feb 2019

Primary outcome: Primary: Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM) — 21.1; 10.3 mmHg — p=0.045

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Distal renal denervation (Procedure); Conventional renal denervation (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Primary completion: Jul 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)	21.1; 10.3	0.045 sig
SECONDARY Number of Adverse Events	4; 2	—
SECONDARY Number of Adverse Events	4; 2	—
SECONDARY Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Right Segmental Renal Arteries	0.018; 0.017	0.96
SECONDARY Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Left Segmental Renal Arteries	0.006; 0.032	0.203
SECONDARY Changes of Serum Creatinine	9.8; 2.0	0.17
SECONDARY Changes of Serum Creatinine	9.8; 2.0	0.17
SECONDARY Changes of Estimated Glomerular Filtration Rate (eGFR)	-7.6; -1.3	—
SECONDARY Changes of Estimated Glomerular Filtration Rate (eGFR)	-7.6; -1.3	—
SECONDARY Changes of 24h-mean Diastolic BP	11.2; 7.9	0.304
SECONDARY Changes of 24h-mean Systolic BP	22.1; 11.5	0.041 sig
SECONDARY Changes of 24h-mean Diastolic BP	11.2; 7.9	0.304
SECONDARY Changes of Office Systolic BP	12.8; 10.8	0.66
SECONDARY Changes of Office Systolic BP	12.8; 10.8	0.66
SECONDARY Changes of Office Diastolic BP	12.8; 10.8	0.66
SECONDARY Changes of Office Diastolic BP	12.8; 10.8	0.66
SECONDARY Changes of Daytime Systolic BP	22.2; 10.9	0.04 sig
SECONDARY Changes of Daytime Mean Systolic BP	22.1; 11.5	0.054
SECONDARY Changes of Daytime Mean Diastolic BP	11.3; 7.9	0.324
SECONDARY Changes of Daytime Mean Diastolic BP	11.3; 7.9	0.324
SECONDARY Changes of Nighttime Mean Systolic BP	17.8; 10.9	0.238
SECONDARY Changes of Nighttime Mean Systolic BP	17.8; 10.9	0.238
SECONDARY Changes of Nighttime Mean Diastolic BP	7.2; 7.5	0.37
SECONDARY Changes of Nighttime Mean Diastolic BP	7.2; 7.5	0.37

Summary

Objective of this study is to evaluate whether a distal mode of endovascular renal denervation with the treatment performed primarily in segmental branches of renal artery is more effective than conventional mode of the intervention with the treatment equally distributed within its main trunk for the treatment of drug-resistant hypertension.

Eligibility Criteria

Inclusion Criteria

systolic BP is equal or greater than 160 mmHg or diastolic BP is equal or greater than 100 mmHg,
stable (>3 months) treatment with full doses of at least 3 antihypertensive drugs including a diuretic,
given written informed consent

Exclusion Criteria

secondary hypertension
24h-mean systolic BP <135 mmHg,
estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2,
extended disease of renal artery,
any other clinically important disorders/comorbidities significantly increasing risk of endovascular intervention (investigator's assessment)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02667912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.