Distal Renal Denervation to Prevent Renal Function Decline in Patients With T2DM and Hypertension
NCT04948918 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2023-11-29
Summary
The aim of this study is to test the hypothesis that distal renal denervation (RDN) may delay or prevent the progressive decline of renal function in patients with type 2 diabetes mellitus and hypertension
Conditions
Interventions
- PROCEDURE
-
Anatomically optimized distal renal denervation
Bilateral radiofrequency renal denervation will be performed using Symplicity Spyral renal denervation system. Generally, at least two separate applications of radiofrequency energy will be performed in each segmental branch of renal artery. Each application will be done through 4 electrodes deployed in helical manner according to the design of the catheter
Sponsors & Collaborators
-
Tomsk National Research Medical Center of the Russian Academy of Sciences
lead OTHER
Principal Investigators
-
Alla Falkovskaya, MD, PhD · Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-20
- Primary Completion
- 2022-09-20
- Completion
- 2023-09-20
Countries
- Russia
Study Locations
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