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

  • STATUS
    Recruiting
  • End date
    Sep 20, 2023
  • participants needed
    30
  • sponsor
    Tomsk National Research Medical Center of the Russian Academy of Sciences
Updated on 4 October 2022
diabetes
hypertension
type 2 diabetes mellitus
kidney function tests
hemoglobin a1c
glucose tolerance test

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 IdentifierNCT04948918
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

informed consent of participation in the study
systolic BP > 140 or diastolic BP > 90 mm Hg
type 2 diabetes mellitus (glucose tolerance test > 11.0 mmol/l, HbA1c>6,5%)

Exclusion Criteria

secondary hypertension
type 1 diabetes mellitus
acute renal failure
traumatic kidney injury
toxic kidney injury
CKD G4 and G5 according to the KDIGO 2012
infectious diseases requiring active antibacterial and/or antiviral therapy
other severe diseases and conditions
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