Status:
COMPLETED
The Effect of Renal Denervation on Biological Variables
Lead Sponsor:
UMC Utrecht
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Brief Summary
Hypertension is a major and growing public health concern. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a major contributor to the complex pathophysiology of (...
Detailed Description
Objective: The objectives of this study are: the investigation of changes in left ventricular mass (LV mass) after RD using MRI, renal perfusion and renal oxygenation after RD using dynamic contrast e...
Eligibility Criteria
Inclusion
- Individual has a systolic BP ≥160 mmHg (≥150 mmHg for type 2 diabetics) based on an average of 3 office BP readings measured according to the guidelines in appendix A.
- Individual is adhering to a stable drug regimen including 3 or more antihypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrolment) which is expected to be maintained for at least 6 months. Or:
- Has experienced side effects to several anti-hypertensive medications
- Individual is ≥18 years of age.
- Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
Exclusion
- Individual has a treatable secondary cause of hypertension. (it is possible that during baseline procedures secondary causes of hypertension are discovered, those individuals will be excluded from participation of the study.)
- Individual has renal artery anatomy that is ineligible for treatment including:
- Main renal arteries \< 4 mm in diameter or \< 20 mm in length.
- Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets standards for surgical repair or interventional dilation.
- A history of prior renal artery stenting.
- Multiple main renal arteries in either kidney.
- Individual has an estimated glomerular filtration rate (eGFR) of \<30mL/min/1.73m2, using the MDRD calculation.
- Individual has type 1 diabetes mellitus.
- Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- Individual has scheduled or planned surgery or cardiovascular intervention in the next 6 months.
- Individual has hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous.
- Individual has an implantable cardioverter defibrillator (ICD) or pacemaker whose settings cannot allow for RF energy delivery.
- Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, or significant anaemia, or arrhythmias such as atrial fibrillation).
- Individual is pregnant, nursing or planning to be pregnant.
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- Individual is currently enrolled in another investigational drug or device trial.
- Individual is currently being treated with any of the following medications:
- Drugs that cause salt retention (e.g., systemic corticosteroids and fludrocortisone)
- Warfarin or phenprocoumon that cannot be temporarily stopped for the procedure.
- Any contraindications for MRI:
- The presence of implanted cardiac pacemakers and/or auto-implanted cardioverter defibrillators.
- Mechanical cardiac valves.
- Implanted electronic devices like cochlear implants and nerve stimulators.
- Patients who are unable to fit into the bore of the magnet.
- Claustrophobia.
- Prosthesis of a joint.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01427049
Start Date
August 1 2011
End Date
February 1 2014
Last Update
February 2 2017
Active Locations (1)
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1
UMC Utrecht
Utrecht, Utrecht, Netherlands