Uncontrolled Hypertension
Conditions
Keywords
renal sympathetic denervation, renal catheter ablation, hypertension
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.
Interventions
DEVICEBiosense Webster Celcius Thermacool catheter
catheter-based sympathetic renal denervation
Sponsors
Biosense Webster, Inc.
Vivek Reddy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Czechia
Outcome results
None listed