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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Essential Hypertension
- Sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in office systolic blood pressure
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
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-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).
Investigators
Yuehui Yin
Director of the Department
The Second Affiliated Hospital of Chongqing Medical University
Eligibility Criteria
Inclusion Criteria
- •Male and non-pregnant female subjects, 18≤age≤65
- •Essential hypertension
- •Office SBP ≥150mmHg and \< 180mmHg; and DBP ≥90mmHg
- •Average 24-hour ABPM systolic blood pressure is ≥130mmHg, or day-time mean SBP ≥135mmHg, or night-time mean SBP ≥120mmHg, and all SBP of ABMP record \<170mmHg
- •HPLC-MS/MS urinary antihypertensive drugs detection shows negative result after at least two weeks of drug elution period, or one extra week of drug elution period will be given for the second urinary drugs analysis; and the urinary drugs detection can be given in screening date for the subjects without antihypertensive history
- •Renal arteries meet the criteria of renal nerve stimulation, mapping and denervation; and at least one positive-response point occurs in each renal artery
- •Patient understands the purpose of this study, and is willing to participate and sign the Informed Consent
- •Patient is compliant and willing to complete clinical follow-up.
Exclusion Criteria
- •Renal artery anatomy is unqualified including：
- •Diameter \<3.5mm or treatable length \<25mm;
- •Multiple renal arteries and the main renal artery supplies a fraction of the blood flow less than 75%
- •Renal artery stenosis \>50% or any renal artery aneurysms on either side
- •History of renal artery percutaneous transluminal angioplasty (PTA), including balloon angioplasty and stenting
- •eGFR \<45ml/min/1.73m2 (MDRD formula)
- •Hospitalized within one year due to hypertensive crisis
- •Pulse pressure\>80mmHg, or isolated systolic hypertension
- •During running in period, using any antihypertensive drugs without prescription and urinary drugs test shows positive.
- •Participated other clinical trials including both drug and medical device studies within 3 months enrollment
Outcomes
Primary Outcomes
Change in office systolic blood pressure
Time Frame: 3 months after the treatment
Secondary Outcomes
- Change in office diastolic blood pressure (DBP)(3 months)
- Change in mean arterial blood pressure(3 months)
- Change in average 24-hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (SBP)(3 months)
- Change in average night-time ABPM SBP(3 months)
- Change in the blood catecholamines levels of pre-procedure and 3 months after the procedure(3 months)
- Rate of renal artery stenosis assessed by CT angiography(3 months)
- Rate of severe renal dysfunction(3 months)
- Rate of adverse events (AEs), SAEs, and severe cardio-cerebrovascular events(3 months)
- Rate of all-cause death(3 months)
- Change in average day-time ABPM SBP(3 months)