Hypertension, Resistant to Conventional TherapyRe-ShapeNCT01630928
Renal Sympathetic Denervation and Potential Effects on Glucose Metabolism and Cardiovascular Risk-Factors
A study testing Renal sympathetic denervation in people with Hypertension, Resistant to Conventional Therapy, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The Re-Shape CV-Risk Study is a clinical study where renal adrenergic denervation (RDN) is done in high risk patients with treatment-resistant hypertension. RDN is a mini-invasive, percutaneous technique where an ablation catheter is inserted through a femoral artery into the renal arteries, for destruction of the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- What is being tested?
- Renal sympathetic denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2013to Dec 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 Years.
- Resistant hypertension, as defined in the 2007 ESH-ESC guidelines and confirmed by ambulatory or home blood pressure measurements. (Here office BP > 140/90 mmHg on 4 or more antihypertensive drugs in adequate dosages (including one diuretic) or certified drug intolerance).
- No known secondary reason for hypertension
- Negative pregnancy test (preferably blood hCG) for female patients of childbearing potential
- Estimated GFR (glomerular filtration rate) > 45 mL/min/1.73m².
- Willing and able to comply with follow-up requirements
- Signed informed consent
Who cannot join
- Type 1 and type 2 diabetes
- Pregnancy
- Allergy to the contrast medium used during RDN and Iohexol clearance.
- Age > 68 years
- Hemodynamically significant heart valve disease
- Pacemaker or ICD
Show all 10Show fewer
- Medication that may interfere with the procedure (Anticoagulation, Platelet inhibitors, Steroids), if they cannot be temporarily reduced or stopped.
- Cancer
- Patients with transplanted kidneys
- Reno vascular conditions like diameter < 4mm, renal artery stenosis or significant atherosclerosis, previous renal artery stenting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal Sympathetic Denervation for Treatment Resistant Hypertension and Potential Effects on Glucose Metabolism and Cardiovascular Risk-Factors (The Re-Shape CV-Risk Study)
The Re-Shape CV-Risk Study is a clinical study where renal adrenergic denervation (RDN) is done in high risk patients with treatment-resistant hypertension. RDN is a mini-invasive, percutaneous technique where an ablation catheter is inserted through a femoral artery into the renal arteries, for destruction of the adrenergic nerve bundles in the artery adventitia by means of radio-frequency ablation. RDN leads to sympathetic denervation of the kidneys, which in the "Symplicity trials" led to an impressive reduction of blood pressure (- 33 /-11 mmHg). In a pilot study, where 40 % of the patients had diabetes, RDN seemed to have beneficial effects not only on blood pressure, but also on insulin sensitivity and hyperinsulinaemia.
The investigators aim to introduce RDN as a clinical study where blood pressure reduction and methodical, technical aspects will be evaluated, but more importantly, also additional effects of RDN on sub-clinical organ damage (endothelial function, vascular stiffness, fundus-, heart-, kidney injury), quality of life, arrhythmia, and glucose metabolism. The investigators hypothesis is that RDN will have positive effect on glucose metabolism, QOL and sub-clinical organ damage.
- Being tested
- Renal sympathetic denervation
- Keywords
- Renal denervation, Resistant Hypertension, Cardiovascular disease, Diabetes, Quality of LIfe
- Medical subject headings
- Hypertension Resistant to Conventional Therapy, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal sympathetic denervationProcedure or surgery
Also called Symplicity Catheter (Medtronic)
This is a mini-invasive trans-catheter procedure with access via a 6F introducer in one of the femoral arteries. The renal sympathetic nerves arise from T10-L2, arborize around the renal artery and primarily lie within the adventitia. A specialized radiofrequency (RF) ablation catheter is introduced into the renal arteries, first one side, then on the other. Usually, 4-6 two-minute treatments per artery using a proprietary RF generator with automated low power and built-in safety algorithms are sufficient to ablate the sympathetic afferent and efferent fibers.
| Study group | Role | What they receive |
|---|---|---|
| Renal sympathetic denervation | Experimental | Patients with treatment resistant hypertension Receives: Procedure: Renal sympathetic denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Change in blood pressure from baseline to six months after the intervention
Measured: from baseline to six months
Change in blood pressure
Change in blood pressure from baseline to two years after the intervention
Measured: from baseline to two years
Secondary outcomes (14)
Change in quality of Life
The international questionnaires SF-36 and 15-D, with some additional specific questions previously used in international studies will be used for evaluation of RDN effect on symptoms and QOL.
Measured: From baseline to six months
Changes in glucose production and insulin sensitivity
Glucose metabolism will be assessed with oral glucose tolerance test and 2-step euglycemic, hyperinsulinaemic clamp with tracer technique (6,6-2H2-glucose + HOTGINF / measurement of tracer-to-tracee ratio with mass spectrometry): Assessment of endogenous glucose production at fasting condition, at insulin levels around 30 mU/ml (hepatic insulin sensitivity), and at insulin levels of 65-68 mU/ml, imitating the postprandial state (peripheral insulin resistance). Assessment of glucose uptake at these conditions (insulin sensitivity).
Measured: from baseline to six months
Change in quality of Life
The international questionnaires SF-36 and 15-D, with some additional specific questions previously used in international studies will be used for evaluation of RDN effect on symptoms and QOL.
Measured: From baseline to two years
Changes in glucose production and insulin sensitivity
Glucose metabolism will be assessed with oral glucose tolerance test and 2-step euglycemic, hyperinsulinaemic clamp with tracer technique (6,6-2H2-glucose + HOTGINF / measurement of tracer-to-tracee ratio with mass spectrometry): Assessment of endogenous glucose production at fasting condition, at insulin levels around 30 mU/ml (hepatic insulin sensitivity), and at insulin levels of 65-68 mU/ml, imitating the postprandial state (peripheral insulin resistance). Assessment of glucose uptake at these conditions (insulin sensitivity).
Measured: from baseline to two years
Effect of RDN on subclinical organ injury: Myocardium
Long standing hypertension leads to sub-clinical organ damage:
Myocardial and vascular remodeling measured with echo cardiography. Wall stiffness, left ventricular function, hypertrophy and mass.
Measured: from baseline to six months
Effect of RDN on subclinical organ injury: Myocardium
Long standing hypertension leads to sub-clinical organ damage:
Myocardial and vascular remodeling measured with echo cardiography. Wall stiffness, left ventricular function, hypertrophy and mass.
Measured: from baseline to two years
Effect of RDN on subclinical organ injury: Retinal vessels
Long standing hypertension leads to sub-clinical organ damage:
Changes in the microcirculatory vasculature detectable as early changes in retinal vascular caliber or presence of hypertensive retinopathy. High resolution photography (Carl Zeiss Meditec.) and optic coherence tomography of the retina give a direct view to microcirculation. Analyzes will be performed using computer assisted morphometry (IVAN/Retinal Analysis software. Fundus Reading center, University of Wisconsin, Madison USA).
Measured: from baseline to six months
Effect of RDN on subclinical organ injury: Retinal vessels
Long standing hypertension leads to sub-clinical organ damage:
Changes in the microcirculatory vasculature detectable as early changes in retinal vascular caliber or presence of hypertensive retinopathy. High resolution photography (Carl Zeiss Meditec.) and optic coherence tomography of the retina give a direct view to microcirculation. Analyzes will be performed using computer assisted morphometry (IVAN/Retinal Analysis software. Fundus Reading center, University of Wisconsin, Madison USA).
Measured: from baseline to two years
Effect of RDN on subclinical organ injury: Kidneys
Long standing hypertension leads to sub-clinical organ damage:
Renal dysfunction. We will measure serum creatinine, cystatin C, GFR (iohexol clearance), albumine/creatinine ratio and N-Acetyl-ß-glucosaminidase (NAG) in morning urine (two different days) before and after RDN. NAG excretion is a sign of tubular injury.
Measured: from baseline to six months
Effect of RDN on subclinical organ injury: Kidneys
Long standing hypertension leads to sub-clinical organ damage:
Renal dysfunction. We will measure serum creatinine, cystatin C, GFR (iohexol clearance), albumine/creatinine ratio and N-Acetyl-ß-glucosaminidase (NAG) in morning urine (two different days) before and after RDN. NAG excretion is a sign of tubular injury.
Measured: from baseline to two years
Effect of RDN on subclinical organ injury: Endothelial function
Long standing hypertension leads to sub-clinical organ damage:
Impaired endothelial function; assessed with plethysmography under reactive hyperemia + markers of endothelial dysfunction; Peripheral vasodilator function is measured by digital pulse amplitude tonometry using EndoPAT 2000 (Itamar Medical Ltd., Caesarea, Israel). Reactive hyperemia is produced by applying a blood pressure cuff for 5 min at a pressure of 60 mmHg higher than the systolic pressure on the upper part of the arm.
Measured: from baseline to six months
Effect of RDN on subclinical organ injury: Endothelial function
Long standing hypertension leads to sub-clinical organ damage:
Impaired endothelial function; assessed with plethysmography under reactive hyperemia + markers of endothelial dysfunction; Peripheral vasodilator function is measured by digital pulse amplitude tonometry using EndoPAT 2000 (Itamar Medical Ltd., Caesarea, Israel). Reactive hyperemia is produced by applying a blood pressure cuff for 5 min at a pressure of 60 mmHg higher than the systolic pressure on the upper part of the arm.
Measured: from baseline to two years
Effect of RDN on subclinical organ injury: Impedance cardiography
Increased central blood pressure measured in ascending aorta, in addition to "augmentation index" (peak aortic pressure increase/pulse pressure) as a measure of vessel compliance, are independent predictors for hypertensive organ injury (brain, heart, kidneys). Aortic wall-stiffness (compliance) and pulse wave reflection are important determinants for central blood pressure and are among the parameters we indirectly will get from impedance cardiography (Hotman System, HEMO SAPIENS INC, Bucharest, Romania)
Measured: from baseline to two years
Effect of RDN on subclinical organ injury: Impedance cardiography
Increased central blood pressure measured in ascending aorta, in addition to "augmentation index" (peak aortic pressure increase/pulse pressure) as a measure of vessel compliance, are independent predictors for hypertensive organ injury (brain, heart, kidneys). Aortic wall-stiffness (compliance) and pulse wave reflection are important determinants for central blood pressure and are among the parameters we indirectly will get from impedance cardiography (Hotman System, HEMO SAPIENS INC, Bucharest, Romania)
Measured: from baseline to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso, The Royal Norwegian Ministry of Health, Odd Berg Medical research Foundation
- Responsible party
- Sponsor
- Investigators
- Terje K. Steigen, MD, PhD, Principal investigator, Dept. of Cardiology, University Hospital of North Norway and University of Tromsø, NorwayIngrid Toft, MD, PhD, Study chair, Dept. of Nephrology, University Hospital of North Norway and University of TromsøMarit D Solbu, MD, PhD, Study director, Dept of Nephrology, University Hospital of North Norway and University of Tromsø
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630928
- Sponsor's protocol ID
- 2011/1296 (REK)
- Acronym
- Re-Shape
- Status last verified
- May 2016
- First submitted
- 26 Jun 2012
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hanssen TA, Subbotina A, Miroslawska A, Solbu MD, Steigen TK. Quality of life following renal sympathetic denervation in treatment-resistant hypertensive patients: a two-year follow-up study. Scand Cardiovasc J. 2022 Dec;56(1):174-179. doi: 10.1080/14017431.2022.2084562.
PubMed 35686551Miroslawska AK, Gjessing PF, Solbu MD, Fuskevag OM, Jenssen TG, Steigen TK. Renal Denervation for Resistant Hypertension Fails to Improve Insulin Resistance as Assessed by Hyperinsulinemic-Euglycemic Step Clamp. Diabetes. 2016 Aug;65(8):2164-8. doi: 10.2337/db16-0205. Epub 2016 May 31.
PubMed 27246911
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Sympathetic Denervation for Treatment Resistant Hypertension and Potential Effects on Glucose Metabolism and Cardiovascular Risk-Factors (The Re-Shape CV-Risk Study)
- ClinicalTrials.gov ID
- NCT01630928
- Acronym / sponsor ID
- Re-Shape / 2011/1296 (REK)
- Keywords
- Renal denervation, Resistant Hypertension, Cardiovascular disease, Diabetes, Quality of LIfe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso, The Royal Norwegian Ministry of Health, Odd Berg Medical research Foundation
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Jun 2012 (estimated)
- 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 Re-Shape CV-Risk Study is a clinical study where renal adrenergic denervation (RDN) is done in high risk patients with treatment-resistant hypertension. RDN is a mini-invasive, percutaneous technique where an ablation catheter is inserted through a femoral artery into the renal arteries, for destruction of the adrenergic nerve bundles in the artery adventitia by means of radio-frequency ablation. RDN leads to sympathetic denervation of the kidneys, which in the "Symplicity trials" led to an impressive reduction of blood pressure (- 33 /-11 mmHg). In a pilot study, where 40 % of the patients had diabetes, RDN seemed to have beneficial effects not only on blood pressure, but also on insulin sensitivity and hyperinsulinaemia.
The investigators aim to introduce RDN as a clinical study where blood pressure reduction and methodical, technical aspects will be evaluated, but more importantly, also additional effects of RDN on sub-clinical organ damage (endothelial function, vascular stiffness, fundus-, heart-, kidney injury), quality of life, arrhythmia, and glucose metabolism. The investigators hypothesis is that RDN will have positive effect on glucose metabolism, QOL and sub-clinical organ damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal sympathetic denervation | Experimental | Procedure: Renal sympathetic denervationPatients with treatment resistant hypertension |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 Years.
- Resistant hypertension, as defined in the 2007 ESH-ESC guidelines and confirmed by ambulatory or home blood pressure measurements. (Here office BP > 140/90 mmHg on 4 or more antihypertensive drugs in adequate dosages (including one diuretic) or certified drug intolerance).
- No known secondary reason for hypertension
- Negative pregnancy test (preferably blood hCG) for female patients of childbearing potential
- Estimated GFR (glomerular filtration rate) > 45 mL/min/1.73m².
Key exclusion criteria (10 listed)
- Type 1 and type 2 diabetes
- Pregnancy
- Allergy to the contrast medium used during RDN and Iohexol clearance.
- Age > 68 years
- Hemodynamically significant heart valve disease
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 |
|---|---|---|
| Renal sympathetic denervationAlso: Symplicity Catheter (Medtronic)This is a mini-invasive trans-catheter procedure with access via a 6F introducer in one of the femoral arteries. The renal sympathetic nerves arise from T10-L2, arborize around the renal artery and primarily lie within the adventitia. A specialized radiofrequency (RF) ablation catheter is introduced into the renal arteries, first one side, then on the other. Usually, 4-6 two-minute treatments per artery using a proprietary RF generator with automated low power and built-in safety algorithms are sufficient to ablate the sympathetic afferent and efferent fibers. | Procedure or surgery | Renal sympathetic denervation |
Primary outcome
Change in blood pressure
Time frame: from baseline to six months
Change in blood pressure from baseline to six months after the intervention
Change in blood pressure
Time frame: from baseline to two years
Change in blood pressure from baseline to two years after the intervention
14 secondary outcomes
Change in quality of Life
Time frame: From baseline to six months
Changes in glucose production and insulin sensitivity
Time frame: from baseline to six months
Change in quality of Life
Time frame: From baseline to two years
Changes in glucose production and insulin sensitivity
Time frame: from baseline to two years
Effect of RDN on subclinical organ injury: Myocardium
Time frame: from baseline to six months
Effect of RDN on subclinical organ injury: Myocardium
Time frame: from baseline to two years
Effect of RDN on subclinical organ injury: Retinal vessels
Time frame: from baseline to six months
Effect of RDN on subclinical organ injury: Retinal vessels
Time frame: from baseline to two years
Effect of RDN on subclinical organ injury: Kidneys
Time frame: from baseline to six months
Effect of RDN on subclinical organ injury: Kidneys
Time frame: from baseline to two years
Effect of RDN on subclinical organ injury: Endothelial function
Time frame: from baseline to six months
Effect of RDN on subclinical organ injury: Endothelial function
Time frame: from baseline to two years
Effect of RDN on subclinical organ injury: Impedance cardiography
Time frame: from baseline to two years
Effect of RDN on subclinical organ injury: Impedance cardiography
Time frame: from baseline to six 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 16 May 2016.
- Derived from this study: PubMed 35686551Hanssen TA, Subbotina A, Miroslawska A, Solbu MD, Steigen TK. Quality of life following renal sympathetic denervation in treatment-resistant hypertensive patients: a two-year follow-up study. Scand Cardiovasc J. 2022 Dec;56(1):174-179. doi: 10.1080/14017431.2022.2084562.
- Derived from this study: PubMed 27246911Miroslawska AK, Gjessing PF, Solbu MD, Fuskevag OM, Jenssen TG, Steigen TK. Renal Denervation for Resistant Hypertension Fails to Improve Insulin Resistance as Assessed by Hyperinsulinemic-Euglycemic Step Clamp. Diabetes. 2016 Aug;65(8):2164-8. doi: 10.2337/db16-0205. Epub 2016 May 31.
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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.
Terje K. Steigen, MD, PhD principal investigator
Dept. of Cardiology, University Hospital of North Norway and University of Tromsø, Norway
Ingrid Toft, MD, PhD study chair
Dept. of Nephrology, University Hospital of North Norway and University of Tromsø
Marit D Solbu, MD, PhD study director
Dept of Nephrology, University Hospital of North Norway and University of Tromsø
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal sympathetic denervation in people with Hypertension, Resistant to Conventional Therapy, run by University Hospital of North Norway at 1 site in Norway.
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 7 inclusion and 10 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 16 May 2016. 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 Norway. 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 blood pressure (time frame: from baseline to six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01630928, which also lists 2 linked publications.
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 16 May 2016; AzTrials last refreshed its copy on 7 Nov 2026.