NCT04948918

Distal Renal Denervation to Prevent Renal Function Decline in Patients With T2DM and Hypertension

Efficacy of Distal Renal Denervation for Preventing Decline in Renal Function in Patients With Type 2 Diabetes Mellitus and Hypertension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

Detailed Description: Diabetes mellitus and hypertension are two major causes of chronic kidney disease (CKD) that starts as subclinical decline in renal function that silently progresses to symptomatic advanced stages associated with irreversible significant damage of the kidney structure. Recent major improvements in pharmacotherapy of hypertension and diabetes have substantially reduced the prevalence of cardiovascular complications, yet, the frequency of CKD remains largely unchanged. Renal denervation is a new minimally invasive method to create regional blockade of the renal sympathetic nerves that is currently used as non-pharmacological therapy of hypertension. The CKD is likewise mediated by overactivity of renal sympathetic system so that RDN has strong potential to prevent development or progression of CKD. The new anatomically optimized distal RDN may have additional benefit in this regard. Denervation of the distal vessels involved in tonic regulation of renal blood should cause a significant drop in renal vascular resistance and proportional increase in blood and oxygen supply to the kidney preventing/reducing chronic hypoxia of renal tissue that is major mechanism of CKD. The aim of this study is to prove the aforementioned concept. For this purpose the eligible patients with type 2 diabetes mellitus and hypertension will undergo distal renal denervation performed using dedicated radiofrequency catheter Symplicity Spyral. The changes in the kidney function and structure as well as BPs (office and ambulatory) will be assessed at baseline, 6 and 12 months post-procedure

Conditions

• Type 2 Diabetes Mellitus
• Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-20
• Primary completion: 2022-09-20
• Completion: 2023-09-20
• First posted: 2021-07-02
• Last updated: 2023-11-29

Locations

1 site across 1 country: Russia