Distal Renal Denervation

Hypertension, Resistant to Conventional Therapy Clinical Trial

Official title:

Anatomically Optimized Distal Renal Denervation for Treatment of Resistant Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667912
• Other study ID #: 022
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: October 2021
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Recent spectacular failure of renal denervation (RDN) therapy in SymplicityHTN-3 trial in fact might be easily predicted from the very beginning. Conventional RDN done as 4-6 point treatments equally distributed within main trunk of renal artery (RA) may only be effective if renal plexus tightly surrounds the artery throughout its whole course with equal longitudinal and circumferential density of the nerve fibers. While this idea itself is unnaturally idealistic also a number of surgical studies demonstrated that proximally majority of renal nerves go at a distance from RA obliquely to its course and join the artery mainly in its distal part (fan-shaped renal plexus with wide base directed toward aorta and apex converging to renal gate). We developed a distal mode of RDN targeting segmental branches of RA and conducted a single-center double-blind randomized controlled parallel group study to compare its efficacy and safety to those of conventional RDN in patients with drug-resistant hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Resistant to Conventional Therapy

Intervention

Procedure:
• Distal renal denervation
Percutaneous endovascular intervention when catheter-based electrode (Symplicity Flex; Medtronic, Inc.) is used for stepwise radiofrequency energy delivery to segmental branches of the renal artery in a number of points distributed along the length and circumference of the vessels in order to ablate renal nerve plexus
• Conventional renal denervation
Percutaneous endovascular intervention when catheter-based electrode (Symplicity Flex; Medtronic, Inc.) is used for stepwise radiofrequency energy delivery to the main trunk of the renal artery in a number of points equally distributed along its length and circumference in order to ablate renal nerve plexus

Locations

Country	Name	City	State
Russian Federation	Tomsk National Research Medical Center of the Russian Academy of Sciences	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

Pekarskiy SE, Baev AE, Mordovin VF, Semke GV, Ripp TM, Falkovskaya AU, Lichikaki VA, Sitkova ES, Zubanova IV, Popov SV. Denervation of the distal renal arterial branches vs. conventional main renal artery treatment: a randomized controlled trial for treat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)		From baseline to 6 months
Secondary	Number of Adverse Events		From baseline to 6 months
Secondary	Number of Adverse Events		From baseline to 12 months
Secondary	Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Right Segmental Renal Arteries	Resistance index is calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry	From baseline to 6 months
Secondary	Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Left Segmental Renal Arteries	Resistance index calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry	From baseline to 6 months
Secondary	Changes of Serum Creatinine		From baseline to 6 months
Secondary	Changes of Serum Creatinine		From baseline to 12 months
Secondary	Changes of Estimated Glomerular Filtration Rate (eGFR)		From baseline to 6 months
Secondary	Changes of Estimated Glomerular Filtration Rate (eGFR)		From baseline to 12 months
Secondary	Changes of 24h-mean Diastolic BP		From baseline to 6 months
Secondary	Changes of 24h-mean Systolic BP		From baseline to 12 months
Secondary	Changes of 24h-mean Diastolic BP		From baseline to 12 months
Secondary	Changes of Office Systolic BP		From baseline to 6 months
Secondary	Changes of Office Systolic BP		From baseline to 12 months
Secondary	Changes of Office Diastolic BP		From baseline to 6 months
Secondary	Changes of Office Diastolic BP		From baseline to 12 months
Secondary	Changes of Daytime Systolic BP		From baseline to 6 months
Secondary	Changes of Daytime Mean Systolic BP		From baseline to 12 months
Secondary	Changes of Daytime Mean Diastolic BP		From baseline to 6 months
Secondary	Changes of Daytime Mean Diastolic BP		From baseline to 12 months
Secondary	Changes of Nighttime Mean Systolic BP		From baseline to 6 months
Secondary	Changes of Nighttime Mean Systolic BP		From baseline to 12 months
Secondary	Changes of Nighttime Mean Diastolic BP		From baseline to 6 months
Secondary	Changes of Nighttime Mean Diastolic BP		From baseline to 12 months