NCT03885843

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

March 20, 2019

Last Update Submit

March 22, 2019

Conditions

Essential HypertensionVascular DiseasesCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in office systolic blood pressure

    3 months after the treatment

Secondary Outcomes (10)

  • Change in average 24-hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (SBP)

    3 months

  • Change in average day-time ABPM SBP

    3 months

  • Change in average night-time ABPM SBP

    3 months

  • Change in office diastolic blood pressure (DBP)

    3 months

  • Change in mean arterial blood pressure

    3 months

  • +5 more secondary outcomes

Study Arms (2)

RDN Group

EXPERIMENTAL

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

Sham Group

SHAM COMPARATOR

renal artery angiography group, without any renal nerve stimulation, mapping or denervation

Procedure: Sham Procedure: Renal angiography

Interventions

Renal nerve stimulation, mapping and denervationPROCEDURE

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.

RDN Group
Sham Procedure: Renal angiographyPROCEDURE

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

Sham Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \. 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 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.
  • \. 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:
  • Essential pulmonary arterial hypertension
  • Type I diabetes
  • Severe cardiac valvular stenosis with contradictions to significantly reduce blood pressure
  • History of myocardial infraction (MI), unstable angina, syncope or cerebrovascular accidents within half year.
  • History of primary aldosteronism, pheochromocytoma, aorta stenosis, hyperthyroidism or hyperparathyroidism
  • 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)
  • Plans to have surgery or cardiovascular interventions within following 6 months
  • Alcohol abuse or unknown drug dependence history
  • Neuroticisms such as depression or anxiety disorders
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2ndChongqingMU

Chongqing, Chongqing Municipality, 400010, China

Location

MeSH Terms

Conditions

Essential HypertensionVascular DiseasesCardiovascular Diseases

Interventions

Denervation

Condition Hierarchy (Ancestors)

Hypertension

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Yuehui Yin, MD

CONTACT

0086-13508335502yinyh63@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 22, 2019

Study Start

June 1, 2019

Primary Completion

January 1, 2020

Study Completion

April 1, 2020

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

CN(1)