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Trial record 3 of 21 for:    symplicity 2

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

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ClinicalTrials.gov Identifier: NCT04948918
Recruitment Status : Recruiting
First Posted : July 2, 2021
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Tomsk National Research Medical Center of the Russian Academy of Sciences

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Hypertension Procedure: Anatomically optimized distal renal denervation Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Distal Renal Denervation for Preventing Decline in Renal Function in Patients With Type 2 Diabetes Mellitus and Hypertension
Actual Study Start Date : September 20, 2020
Estimated Primary Completion Date : September 20, 2022
Estimated Study Completion Date : September 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Experimental: Distal renal denervation
The arm comprises patients undergoing distal bilateral radiofrequency renal denervation performed using Symplicity Spyral renal denervation system.
Procedure: Anatomically optimized distal renal denervation
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




Primary Outcome Measures :
  1. Change in estimated glomerular filtration rate renal function (eGFR) [ Time Frame: from baseline to 12 months ]
    eGFR calculated using CKD-EPI formula


Secondary Outcome Measures :
  1. Change in eGFR [ Time Frame: from baseline 12 months ]
    eGFR calculated using CKD-EPI formula

  2. Change in office blood pressure levels (systolic/diastolic) [ Time Frame: from baseline to 6 months and 12 months ]
    Blood pressure measurement performed by physician in office

  3. Change in ambulatory 24-hour blood pressure levels (24-h mean, daytime, nighttime; systolic/diastolic) [ Time Frame: from baseline to 6 and 12 months ]
    Mean values for respective periods calculated from ambulatory blood pressure monitoring performed using automatic measurement device

  4. Change in cystatin C levels [ Time Frame: from baseline to 6 and 12 months ]
    blood analysis

  5. Change in lipocalin 2 (NGAL) levels [ Time Frame: from baseline to 6 and 12 months ]
    blood analysis

  6. Change in 24-hour urinary albumin excretion [ Time Frame: from baseline to 6 and 12 months ]
    urinalysis

  7. Change in the cortical and medullary volume of the kidneys and their ratio according to MRI [ Time Frame: from baseline to 12 months ]
    Cortical and medullary volume measured using magnetic resonance imaging

  8. Prognostic significance of baseline HbA1c value with regard to change in eGFR [ Time Frame: from baseline to 6 and 12 months ]
    Will be assessed from multiple regression model of linear dependence of change in eGFR on a number of independent variables including in addition to HbA1c also age, sex, baseline eGFR, and 24-h ambulatory systolic BP

  9. Change in renal resistive index in a trunk [ Time Frame: from baseline to 6 and 12 months ]
    resistive index calculated using blood flow velocity on Doppler ultrasound

  10. Change in peak linear blood flow velocity in the trunk and in segmental renal arteries [ Time Frame: from baseline to 6 and 12 months ]
    blood flow velocity assessed by Doppler flowmetry in the trunk of the renal arteries and in segmental renal arteries using averaged values



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04948918


Contacts
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Contact: Alla Falkovskaya, PhD +7-913-884-52-69 alla@cardio-tomsk.ru

Locations
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Russian Federation
Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences Recruiting
Tomsk, Russian Federation, 634012
Contact: Alla Falkovskaya, PhD    +7-913-884-52-69    alla@cardio-tomsk.ru   
Principal Investigator: Stanislav Pekarskiy, PhD         
Sponsors and Collaborators
Tomsk National Research Medical Center of the Russian Academy of Sciences
Investigators
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Study Director: Alla Falkovskaya, PhD Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences
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Responsible Party: Tomsk National Research Medical Center of the Russian Academy of Sciences
ClinicalTrials.gov Identifier: NCT04948918    
Other Study ID Numbers: 005/e3
First Posted: July 2, 2021    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tomsk National Research Medical Center of the Russian Academy of Sciences:
hypertension
diabetes mellitus
kidney
renal function
denervation
blood pressure
Additional relevant MeSH terms:
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Hypertension
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases