Ignite Creation Date:
2024-05-06 @ 12:56 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03885843
Status:
UNKNOWN
Last Update Posted:
2019-03-25
First Post:
2019-03-20
Brief Title:
Sympathetic Mapping Ablation of Renal Nerves Trial SMART HTN-OFF MED Study
Sponsor:
The Second Affiliated Hospital of Chongqing Medical University
Organization:
The Second Affiliated Hospital of Chongqing Medical University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART OFF-MED
Brief Summary:
To evaluate the efficacy and safety of selected renal sympathetic denervation using SyMapCath I Catheter and SYMPIONEER S1 StimulatorGenerator 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-MSMS 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
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
Detailed Description:
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-MSMS 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 11 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 collectingmanagementstatistical analysis and laboratory tests will be performed by independent qualified organizations Independent Data Safety and Monitoring BoardClinical Events Committee DSMBCEC are formed and responsible for assessments of protocol deviations and natures of serious adverse events SAEs
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 11 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 collectingmanagementstatistical analysis and laboratory tests will be performed by independent qualified organizations Independent Data Safety and Monitoring BoardClinical Events Committee DSMBCEC are formed and responsible for assessments of protocol deviations and natures of serious adverse events SAEs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None