Renal Sympathetic Denervation for the Management of Chronic Hypertension
- Conditions
- Uncontrolled Hypertension
- Interventions
- Device: Biosense Webster Celcius Thermacool catheter
- Registration Number
- NCT01628172
- Lead Sponsor
- Vivek Reddy
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- ≥ 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biosense Webster Celcius Thermacool catheter Biosense Webster Celcius Thermacool catheter These subjects will undergo catheter-based sympathetic renal denervation. Ablation arm
- Primary Outcome Measures
Name Time Method Change in 24-hour ambulatory BP baseline and at 6 months Differences in 24-hour ambulatory blood pressure measurements recorded at baseline and at 6 months for each patient.
- Secondary Outcome Measures
Name Time Method change in office BP baseline, 6 months, and 12 months Difference in office blood pressure measurements at 6 months and at 12 months as compared to baseline.
change in ambulatory BP baseline and at 12 months Difference in 24 hour ambulatory blood pressure measurements at 12 months compared to baseline
Renal artery dimensions baseline and at 6 months Change in renal artery dimensions at 6 months.
Creatinine baseline and at 6 months Differences in creatinine measurements recorded at baseline and at 6 months for each patient.
Trial Locations
- Locations (2)
Fakultní nemocnice u sv. Anny v Brně
🇨🇿Brno, Czech Republic
Na Homolce Hospital
🇨🇿Prague, Czech Republic