Sympathetic Mapping/ Ablation of Renal Nerves Trial (SMART) HTN-OFF MED Study (SMART OFF-MED)
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|ClinicalTrials.gov Identifier: NCT03885843|
Recruitment Status : Not yet recruiting
First Posted : March 22, 2019
Last Update Posted : March 25, 2019
To evaluate the efficacy and safety of selected renal sympathetic denervation using SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator in patients with hypertension in the absence of antihypertensive medications, or till the negative result was given by urinary antihypertensive drugs detection of high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) after at least two weeks of drug elution period.
Then Office systolic blood pressure (SBP) is still ≥ 150mmHg, < 180mmHg, diastolic blood pressure (DBP) ≥ 90mmHg, and 24-hour mean SBP of ambulatory blood pressure measurement (ABPM) is ≥130mmHg, or day-time mean SBP ≥135mmHg, or night-time mean SBP ≥120mmHg, and all SBP of ABMP record <170mmHg.
After then the patient will be included when the results of bilateral renal angiography meet the requirements of renal nerve stimulation, mapping and denervation conditions.
|Condition or disease||Intervention/treatment||Phase|
|Essential Hypertension Vascular Diseases Cardiovascular Diseases||Procedure: Renal nerve stimulation, mapping and denervation Procedure: Sham Procedure: Renal angiography||Not Applicable|
This is a prospective, multicenter, blind, randomized and controlled trial, in which patients are of essential hypertension, but in the absence of antihypertensive medications. The patients will be informed, consent and get into a screening process. After at least two weeks of drug elution period HPLC-MS/MS urinary antihypertensive drugs detection will be given till the negative result, or one extra week of drug elution period will be given for the second urinary drugs analysis. Then Office systolic blood pressure (SBP) is still ≥ 150mmHg, < 180mmHg, diastolic blood pressure (DBP) ≥ 90mmHg, and 24-hour mean SBP of ambulatory blood pressure measurement (ABPM) is ≥130mmHg, or day-time mean SBP ≥135mmHg, or night-time mean SBP ≥120mmHg, and all SBP of ABMP record <170mmHg.
These patients will conduct renal angiography, and the meet inclusion criteria individuals will be allocated to either renal nerve stimulation, mapping and denervation group (RDN group) or renal artery angiography group (Sham group) by a randomizing system in a 1:1 ratio (80 patients, 40 pairs). Physicians who perform post-procedure patient management and physicians who perform renal denervation procedures are blinded to each other.
Patients will be followed at the 2nd day, the 7th day after the procedure or at discharge from hospital, 1st month, 2nd month, 3rd month. Urine samples will be collected for drug tests to determine drug compliance of a patient.
Data collecting/management/statistical analysis and laboratory tests will be performed by independent, qualified organizations. Independent Data Safety and Monitoring Board/Clinical Events Committee (DSMB/CEC) are formed and responsible for assessments of protocol deviations and natures of serious adverse events (SAEs).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||A Prospective, Multicenter, Blind, Randomized and Controlled Trial of Selected Renal Denervation by Renal Nerve Mapping for the Treatment of Hypertension (HTN) in the Absence of Antihypertensive Medications (OFF MED)|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||April 1, 2020|
Experimental: RDN Group
renal nerve stimulation, mapping and denervation using the SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator after renal angiography.
Procedure: Renal nerve stimulation, mapping and denervation
After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal nerve stimulation, mapping and denervation procedure after randomization.
Sham Comparator: Sham Group
renal artery angiography group, without any renal nerve stimulation, mapping or denervation
Procedure: Sham Procedure: Renal angiography
After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal
- Change in office systolic blood pressure [ Time Frame: 3 months after the treatment ]
- Change in average 24-hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (SBP) [ Time Frame: 3 months ]
- Change in average day-time ABPM SBP [ Time Frame: 3 months ]
- Change in average night-time ABPM SBP [ Time Frame: 3 months ]
- Change in office diastolic blood pressure (DBP) [ Time Frame: 3 months ]
- Change in mean arterial blood pressure [ Time Frame: 3 months ]
- Change in the blood catecholamines levels of pre-procedure and 3 months after the procedure [ Time Frame: 3 months ]
- Rate of renal artery stenosis assessed by CT angiography [ Time Frame: 3 months ](stenosis > 70% )
- Rate of severe renal dysfunction [ Time Frame: 3 months ]eGFR<15ml/min/m2 or renal function replacement therapy needed
- Rate of adverse events (AEs), SAEs, and severe cardio-cerebrovascular events [ Time Frame: 3 months ]
- Rate of all-cause death [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885843
|Contact: Yuehui Yin, MDfirstname.lastname@example.org|
|Chongqing, Chongqing, China, 400010|