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

NCT04948918 | Completed

• 1 other identifier: 005/e3
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes Mellitus; Hypertension

Keywords

hypertension; diabetes mellitus; kidney; renal function; denervation; blood pressure

Outcome Measures

Primary Outcomes (1)

• Change in estimated glomerular filtration rate renal function (eGFR)

  eGFR calculated using CKD-EPI formula

  from baseline to 12 months

Secondary Outcomes (10)

• Change in eGFR

  from baseline 12 months

• Change in office blood pressure levels (systolic/diastolic)

  from baseline to 6 months and 12 months

• Change in ambulatory 24-hour blood pressure levels (24-h mean, daytime, nighttime; systolic/diastolic)

  from baseline to 6 and 12 months

• Change in cystatin C levels

  from baseline to 6 and 12 months

• Change in lipocalin 2 (NGAL) levels

  from baseline to 6 and 12 months

Study Arms (1)

Distal renal denervation

EXPERIMENTAL

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

Procedure: Anatomically optimized distal renal denervation

Interventions

Anatomically optimized distal renal denervation PROCEDURE

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

Distal renal denervation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%);

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences

Tomsk, 634012, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alla Falkovskaya, MD, PhD

  Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 2, 2021
• Study Start: September 20, 2020
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

RU (1)