Type 2 Diabetes MellitusREFRAINNCT04948918
Distal Renal Denervation to Prevent Renal Function Decline in Patients With T2DM and Hypertension
A study testing Anatomically optimized distal renal denervation in people with Type 2 Diabetes Mellitus and Hypertension, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypertension
- What is being tested?
- Anatomically optimized distal renal denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteRussia
- Study dates
- 20 Sep 2020to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%);
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Russia1 site
Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences
Tomsk, 634012
About this study
Official title: Efficacy of Distal Renal Denervation for Preventing Decline in Renal Function in Patients With Type 2 Diabetes Mellitus and Hypertension
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
Read the 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
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Being tested
- Anatomically optimized distal renal denervation
- Keywords
- hypertension, diabetes mellitus, kidney, renal function, denervation, blood pressure
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomically optimized distal renal denervationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Distal renal denervation | Experimental | The arm comprises patients undergoing distal bilateral radiofrequency renal denervation performed using Symplicity Spyral renal denervation system. Receives: Procedure: Anatomically optimized distal renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in estimated glomerular filtration rate renal function (eGFR)
eGFR calculated using CKD-EPI formula
Measured: from baseline to 12 months
Secondary outcomes (10)
Change in eGFR
eGFR calculated using CKD-EPI formula
Measured: from baseline 12 months
Change in office blood pressure levels (systolic/diastolic)
Blood pressure measurement performed by physician in office
Measured: from baseline to 6 months and 12 months
Change in ambulatory 24-hour blood pressure levels (24-h mean, daytime, nighttime; systolic/diastolic)
Mean values for respective periods calculated from ambulatory blood pressure monitoring performed using automatic measurement device
Measured: from baseline to 6 and 12 months
Change in cystatin C levels
blood analysis
Measured: from baseline to 6 and 12 months
Change in lipocalin 2 (NGAL) levels
blood analysis
Measured: from baseline to 6 and 12 months
Change in 24-hour urinary albumin excretion
urinalysis
Measured: from baseline to 6 and 12 months
Change in the cortical and medullary volume of the kidneys and their ratio according to MRI
Cortical and medullary volume measured using magnetic resonance imaging
Measured: from baseline to 12 months
Prognostic significance of baseline HbA1c value with regard to change in eGFR
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
Measured: from baseline to 6 and 12 months
Change in renal resistive index in a trunk
resistive index calculated using blood flow velocity on Doppler ultrasound
Measured: from baseline to 6 and 12 months
Change in peak linear blood flow velocity in the trunk and in segmental renal arteries
blood flow velocity assessed by Doppler flowmetry in the trunk of the renal arteries and in segmental renal arteries using averaged values
Measured: from baseline to 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start20 Sep 2020
- Primary completion20 Sep 2022
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alla Falkovskaya, MD, PhD, Study director, Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948918
- Sponsor's protocol ID
- 005/e3
- Acronym
- REFRAIN
- Status last verified
- Nov 2023
- First submitted
- 24 Jun 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Distal Renal Denervation for Preventing Decline in Renal Function in Patients With Type 2 Diabetes Mellitus and Hypertension
- ClinicalTrials.gov ID
- NCT04948918
- Acronym / sponsor ID
- REFRAIN / 005/e3
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Keywords
- hypertension, diabetes mellitus, kidney, renal function, denervation, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distal renal denervation | Experimental | Procedure: Anatomically optimized distal renal denervationThe arm comprises patients undergoing distal bilateral radiofrequency renal denervation performed using Symplicity Spyral renal denervation system. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%);
Key exclusion criteria (8 listed)
- secondary hypertension;
- type 1 diabetes mellitus;
- acute renal failure;
- traumatic kidney injury;
- toxic kidney injury;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomically optimized distal renal denervationBilateral 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 | Procedure or surgery | Distal renal denervation |
Primary outcome
Change in estimated glomerular filtration rate renal function (eGFR)
Time frame: from baseline to 12 months
eGFR calculated using CKD-EPI formula
10 secondary outcomes
Change in eGFR
Time frame: from baseline 12 months
Change in office blood pressure levels (systolic/diastolic)
Time frame: from baseline to 6 months and 12 months
Change in ambulatory 24-hour blood pressure levels (24-h mean, daytime, nighttime; systolic/diastolic)
Time frame: from baseline to 6 and 12 months
Change in cystatin C levels
Time frame: from baseline to 6 and 12 months
Change in lipocalin 2 (NGAL) levels
Time frame: from baseline to 6 and 12 months
Change in 24-hour urinary albumin excretion
Time frame: from baseline to 6 and 12 months
Change in the cortical and medullary volume of the kidneys and their ratio according to MRI
Time frame: from baseline to 12 months
Prognostic significance of baseline HbA1c value with regard to change in eGFR
Time frame: from baseline to 6 and 12 months
Change in renal resistive index in a trunk
Time frame: from baseline to 6 and 12 months
Change in peak linear blood flow velocity in the trunk and in segmental renal arteries
Time frame: from baseline to 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alla Falkovskaya, MD, PhD study director
Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomically optimized distal renal denervation in people with Type 2 Diabetes Mellitus and Hypertension, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in estimated glomerular filtration rate renal function (eGFR) (time frame: from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.