Renal Sympathetic Denervation for the Management of Chronic Hypertension

Study Overview
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Brief Summary
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Despite the development of numerous drug therapies designed to treat hypertension, it remains a considerable and poorly managed health, social and economic burden. For various reasons, including the significant health care costs of treatment, there are estimates that up to 65% of hypertensive patients have untreated and/or uncontrolled blood pressure (BP). Aside from its impact on renal function, chronic hypertension significantly increases the risk for stroke, coronary artery disease, heart failure, and vascular disease. It is believed to be involved in the progression of cardiac arrhythmias. This link between hypertension and cardiovascular health has been well described; as has their combined effect on the aging and obesity-battling Western world. The recently published results of the Symplicity HTN-2 trial (Renal sympathetic denervation in patients with treatment resistant hypertension) establishing the therapeutic benefit of catheter-based renal sympathetic denervation for hypertension, have enormous potential for the management of a large and challenging patient population. The proposed, multicenter trial will attempt to confirm and expand on this promising data by conducting a double-blinded, placebo-controlled trial. Patients may qualify to participate in this research study if their doctor has determined that they have drug-resistant, chronic hypertension. Overall participation in this research study should be about 13 months which includes about 1 month to start the study procedure and 12 months of follow-up after the study procedure.

Detailed Description
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Patients who qualify for the study and provide consent will undergo a renal angiogram in order to assess suitability for catheter-based renal sympathetic denervation. A renal angiogram is an x-ray study of the blood vessels in the kidney to evaluate for blockage, and abnormalities that could be affecting the blood supply to the kidney. It is performed by injecting contrast dye through a catheter (a tiny tube) into the blood vessels of the kidney. The study doctor will assess whether the renal arteries are suitable to receive catheter-based renal denervation. Both groups will receive sedation or anesthesia prior to the beginning of the procedure. The first group will undergo catheter-based sympathetic renal denervation. Renal Sympathetic Denervation is a procedure that uses a catheter probe inserted into the renal (kidney) artery that deactivates the nerves that are linked to high blood pressure. The second group will only receive renal angiography without the delivery of ablative energy.

Official Title
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Renal Sympathetic Denervation for the Management of Chronic Hypertension

Conditions
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Uncontrolled Hypertension

Intervention / Treatment
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* Device: Biosense Webster Celcius Thermacool catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 and ≤ 85 years of age Uncontrolled hypertension (defined as SBP ≥ 140 mmHg during 24Hr Ambulatory BP monitoring) Current treatment with ≥ 3 anti-hypertensive drugs (including at least one diuretic) Accessibility of renal vasculature Ability to understand the requirements of the study Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements Exclusion Criteria: Secondary cause of hypertension White coat hypertension Estimated GFR < 45 Type 1 Diabetes Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty) Life expectancy <1 year for any medical condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biosense Webster Celcius Thermacool catheter<br>These subjects will undergo catheter-based sympathetic renal denervation. Ablation arm | Device: Biosense Webster Celcius Thermacool catheter<br>* catheter-based sympathetic renal denervation<br>* Other names: Ablation arm;|
| No Intervention: renal angiogram only<br>Control Group: Control arm will not receive intervention but will be followed for 1 year. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour ambulatory BP | Differences in 24-hour ambulatory blood pressure measurements recorded at baseline and at 6 months for each patient. | baseline and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in office BP | Difference in office blood pressure measurements at 6 months and at 12 months as compared to baseline. | baseline, 6 months, and 12 months | 
| change in ambulatory BP | Difference in 24 hour ambulatory blood pressure measurements at 12 months compared to baseline | baseline and at 12 months | 
| Renal artery dimensions | Change in renal artery dimensions at 6 months. | baseline and at 6 months | 
| Creatinine | Differences in creatinine measurements recorded at baseline and at 6 months for each patient. | baseline and at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal sympathetic denervation, renal catheter ablation, hypertension