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

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status: Completed

Conditions: Hypertension; Type 2 Diabetes Mellitus

Treatments: Procedure: Anatomically optimized distal renal denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT04948918

005/e3

Details and patient eligibility

About

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

Full 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

Enrollment: 29 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Distal renal denervation

Experimental group

Description:

The arm comprises patients undergoing distal bilateral radiofrequency renal denervation performed using Symplicity Spyral renal denervation system.

Treatment:

Procedure: Anatomically optimized distal renal denervation