Clinical trial NCT04948918: Distal Renal Denervation to Prevent Renal Function Decline in Patients With T2DM and Hypertension
Official title: Efficacy of Distal Renal Denervation for Preventing Decline in Renal Function in Patients With Type 2 Diabetes Mellitus and Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Hypertension
Keywords: hypertension
diabetes mellitus
kidney
renal function
denervation
blood pressure
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in estimated glomerular filtration rate renal function (eGFR)
timeFrame: from baseline to 12 months
Secondary outcomes:
measure: Change in eGFR
timeFrame: from baseline 12 months
measure: Change in office blood pressure levels (systolic/diastolic)
timeFrame: from baseline to 6 months and 12 months
measure: Change in ambulatory 24-hour blood pressure levels (24-h mean, daytime, nighttime; systolic/diastolic)
timeFrame: from baseline to 6 and 12 months
measure: Change in cystatin C levels
timeFrame: from baseline to 6 and 12 months
measure: Change in lipocalin 2 (NGAL) levels
timeFrame: from baseline to 6 and 12 months
measure: Change in 24-hour urinary albumin excretion
timeFrame: from baseline to 6 and 12 months
measure: Change in the cortical and medullary volume of the kidneys and their ratio according to MRI
timeFrame: from baseline to 12 months
measure: Prognostic significance of baseline HbA1c value with regard to change in eGFR
timeFrame: from baseline to 6 and 12 months
measure: Change in renal resistive index in a trunk
timeFrame: from baseline to 6 and 12 months
measure: Change in peak linear blood flow velocity in the trunk and in segmental renal arteries
timeFrame: from baseline to 6 and 12 months
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences
Study officials:
affiliation: Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences
name: Alla Falkovskaya, MD, PhD
role: STUDY_DIRECTOR
References: