Clinical trial NCT01630928: Renal Sympathetic Denervation and Potential Effects on Glucose Metabolism and Cardiovascular Risk-Factors
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Resistant to Conventional Therapy
Keywords: Renal denervation
Resistant Hypertension
Cardiovascular disease
Diabetes
Quality of LIfe
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: University of Tromso
name: The Royal Norwegian Ministry of Health
name: Odd Berg Medical research Foundation
First posted: 2012-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in blood pressure
timeFrame: from baseline to six months
measure: Change in blood pressure
timeFrame: from baseline to two years
Secondary outcomes:
measure: Change in quality of Life
timeFrame: From baseline to six months
measure: Changes in glucose production and insulin sensitivity
timeFrame: from baseline to six months
measure: Change in quality of Life
timeFrame: From baseline to two years
measure: Changes in glucose production and insulin sensitivity
timeFrame: from baseline to two years
measure: Effect of RDN on subclinical organ injury: Myocardium
timeFrame: from baseline to six months
measure: Effect of RDN on subclinical organ injury: Myocardium
timeFrame: from baseline to two years
measure: Effect of RDN on subclinical organ injury: Retinal vessels
timeFrame: from baseline to six months
measure: Effect of RDN on subclinical organ injury: Retinal vessels
timeFrame: from baseline to two years
measure: Effect of RDN on subclinical organ injury: Kidneys
timeFrame: from baseline to six months
measure: Effect of RDN on subclinical organ injury: Kidneys
timeFrame: from baseline to two years
measure: Effect of RDN on subclinical organ injury: Endothelial function
timeFrame: from baseline to six months
measure: Effect of RDN on subclinical organ injury: Endothelial function
timeFrame: from baseline to two years
measure: Effect of RDN on subclinical organ injury: Impedance cardiography
timeFrame: from baseline to two years
measure: Effect of RDN on subclinical organ injury: Impedance cardiography
timeFrame: from baseline to six months
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: Dept. of Cardiology, University Hospital of North Norway and University of Tromsø, Norway
name: Terje K. Steigen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Nephrology, University Hospital of North Norway and University of Tromsø
name: Ingrid Toft, MD, PhD
role: STUDY_CHAIR
affiliation: Dept of Nephrology, University Hospital of North Norway and University of Tromsø
name: Marit D Solbu, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Miroslawska 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.