Renal Sympathetic Denervation for Treatment Resistant Hypertension and Potential Effects on Glucose Metabolism and Cardiovascular Risk-Factors (The Re-Shape CV-Risk Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension, Resistant to Conventional Therapy
- Sponsor
- University Hospital of North Norway
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in blood pressure
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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.
- •Patients with transplanted kidneys
- •Reno vascular conditions like diameter \< 4mm, renal artery stenosis or significant atherosclerosis, previous renal artery stenting
Outcomes
Primary Outcomes
Change in blood pressure
Time Frame: from baseline to two years
Change in blood pressure from baseline to two years after the intervention
Secondary Outcomes
- Change in quality of Life(From baseline to two years)
- Effect of RDN on subclinical organ injury: Myocardium(from baseline to two years)
- Changes in glucose production and insulin sensitivity(from baseline to two years)
- Effect of RDN on subclinical organ injury: Endothelial function(from baseline to two years)
- Effect of RDN on subclinical organ injury: Impedance cardiography(from baseline to six months)
- Effect of RDN on subclinical organ injury: Retinal vessels(from baseline to two years)
- Effect of RDN on subclinical organ injury: Kidneys(from baseline to two years)