Cardiovascular Diseases Clinical Trial
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)
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.
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).
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