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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 : Unknown
Verified March 2019 by Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University.
Recruitment status was:  Not yet recruiting
First Posted : March 22, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University

Tracking Information
First Submitted Date  ICMJE March 20, 2019
First Posted Date  ICMJE March 22, 2019
Last Update Posted Date March 25, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
Change in office systolic blood pressure [ Time Frame: 3 months after the treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • 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 ]
  • All-cause death [ Time Frame: 3 months ]
  • Severe renal dysfunction [ Time Frame: 3 months ]
    eGFR<15ml/min/m2 or renal function replacement therapy needed
  • Rate of renal artery stenosis assessed by CT angiography [ Time Frame: 3 months ]
    (stenosis > 70% )
  • AEs, SAEs, and severe cardio-cerebrovascular events [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sympathetic Mapping/ Ablation of Renal Nerves Trial (SMART) HTN-OFF MED Study
Official Title  ICMJE 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)
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Essential Hypertension
  • Vascular Diseases
  • Cardiovascular Diseases
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • Experimental: RDN Group
    renal nerve stimulation, mapping and denervation using the SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator after renal angiography.
    Intervention: Procedure: Renal nerve stimulation, mapping and denervation
  • Sham Comparator: Sham Group
    renal artery angiography group, without any renal nerve stimulation, mapping or denervation
    Intervention: Procedure: Sham Procedure: Renal angiography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 20, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and non-pregnant female subjects, 18≤age≤65
  2. Essential hypertension
  3. Office SBP ≥150mmHg and < 180mmHg; and DBP ≥90mmHg
  4. 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
  5. 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
  6. Renal arteries meet the criteria of renal nerve stimulation, mapping and denervation; and at least one positive-response point occurs in each renal artery
  7. Patient understands the purpose of this study, and is willing to participate and sign the Informed Consent
  8. Patient is compliant and willing to complete clinical follow-up.

Exclusion Criteria:

1. Renal artery anatomy is unqualified including:

  1. Diameter <3.5mm or treatable length <25mm;
  2. Multiple renal arteries and the main renal artery supplies a fraction of the blood flow less than 75%
  3. Renal artery stenosis >50% or any renal artery aneurysms on either side
  4. History of renal artery percutaneous transluminal angioplasty (PTA), including balloon angioplasty and stenting 2. eGFR <45ml/min/1.73m2 (MDRD formula) 3. Hospitalized within one year due to hypertensive crisis 4. Pulse pressure>80mmHg, or isolated systolic hypertension 5. During running in period, using any antihypertensive drugs without prescription and urinary drugs test shows positive.

6. Participated other clinical trials including both drug and medical device studies within 3 months enrollment 7. Female with pregnant or lactating, or having plans for pregnancy within 1 year 8. Patient with sleep apnea who needs chronic oxygen-breathing or mechanical ventilation support (for example, tracheostomy) 9. Patients previously or currently suffering from following diseases:

  1. Essential pulmonary arterial hypertension
  2. Type I diabetes
  3. Severe cardiac valvular stenosis with contradictions to significantly reduce blood pressure
  4. History of myocardial infraction (MI), unstable angina, syncope or cerebrovascular accidents within half year.
  5. History of primary aldosteronism, pheochromocytoma, aorta stenosis, hyperthyroidism or hyperparathyroidism
  6. Any disease conditions interfering the measurement of blood pressure (for instance, severe peripheral artery diseases, abdominal artery aneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia and severe anemia)
  7. Plans to have surgery or cardiovascular interventions within following 6 months
  8. Alcohol abuse or unknown drug dependence history
  9. Neuroticisms such as depression or anxiety disorders
  10. Non-compliant patients unable to finish the research per physician's requests 10. There is no positive-response point in any renal artery, or any contradictions to conduct renal artery stimulation and ablation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03885843
Other Study ID Numbers  ICMJE SMART HTN-OFF MED
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
Study Sponsor  ICMJE The Second Affiliated Hospital of Chongqing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Second Affiliated Hospital of Chongqing Medical University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP