Distal Renal Denervation to Prevent Renal Function Decline in Patients With T2DM and Hypertension (REFRAIN)
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- STATUS
- Recruiting
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- End date
- Sep 20, 2023
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- participants needed
- 30
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- sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
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
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
Details
| Condition | Type 2 Diabetes Mellitus, Hypertension |
|---|---|
| Treatment | Anatomically optimized distal renal denervation |
| Clinical Study Identifier | NCT04948918 |
| Sponsor | Tomsk National Research Medical Center of the Russian Academy of Sciences |
| Last Modified on | 4 October 2022 |
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