Renal Sympathetic Denervation for the Management of Chronic Hypertension (RELIEF)
Tracking Information | |||||
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First Received Date ICMJE | June 12, 2012 | ||||
Last Updated Date | June 22, 2012 | ||||
Start Date ICMJE | January 2011 | ||||
Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in24-hour ambulatory BP [ Time Frame: baseline and at 6 months ] [ Designated as safety issue: No ] Differences in 24-hour ambulatory blood pressure measurements recorded at baseline and at 6 months for each patient. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01628172 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Renal Sympathetic Denervation for the Management of Chronic Hypertension | ||||
Official Title ICMJE | Renal Sympathetic Denervation for the Management of Chronic 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, multi-center 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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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Condition ICMJE | Uncontrolled Hypertension | ||||
Intervention ICMJE | Device: Biosense Webster Celcius Thermacool catheter
catheter-based sympathetic renal denervation
Other Names:
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Enrolling by invitation | ||||
Estimated Enrollment ICMJE | 100 | ||||
Estimated Completion Date | January 2014 | ||||
Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 85 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Czech Republic | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01628172 | ||||
Other Study ID Numbers ICMJE | GCO 11-0965 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Vivek Reddy, Mount Sinai School of Medicine | ||||
Study Sponsor ICMJE | Vivek Reddy | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Mount Sinai School of Medicine | ||||
Verification Date | June 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |