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HypertensionPhase 3LEPU-RDNNCT02536326

LEPU Renal Denervation System for Resistant Hypertension

A Phase 3 study testing LEPU Renal Denervation System in people with Hypertension and Cardiovascular Diseases, run by Lepu Medical Technology (Beijing) Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose was to evaluate 6-month outcomes of renal denervation(RDN) for the treatment of resistant hypertension in Chinese patients in a prospective cohort study. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
LEPU Renal Denervation System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Nov 2012to May 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65 years
  • Stable medication regimen including ≥3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to RDN)
  • 1) Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour mean SBP and/or DBP ≥140 and/or 90 mmHg
  • Main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation)
  • eGFR ≥45 mL/min/1.73 m2
  • Written informed consent

Who cannot join

  • Clinical Exclusion Criteria:
  • Known secondary hypertension
  • Type 1 diabetes mellitus
  • Has an implantable cardioverter defibrillator (ICD) or pacemaker
  • Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
  • Widespread atherosclerosis with documented intravascular thrombosis or unstable plaques
Show all 16Show fewer
  • Has hemodynamically significant valvular heart disease
  • Pregnant, nursing, or planning to be pregnant
  • Any serious medical condition that may adversely affect the safety of the participant or the study
  • Currently enrolled in another investigational drug or device trial
  • Anatomic Exclusion Criteria
  • Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
  • History of prior renal artery intervention including balloon angioplasty or stenting
  • Multiple renal arteries where the main renal artery is estimated to supply <75% of the kidney
  • Main renal arteries with <4 mm diameter or with <20 mm treatable length (by visual estimation)
  • Renal artery abnormalities

About this study

Official title: LEPU Renal Denervation System for Resistant Hypertension in Chinese Populations

The purpose was to evaluate 6-month outcomes of renal denervation(RDN) for the treatment of resistant hypertension in Chinese patients in a prospective cohort study.

Read the detailed description

Currently, considerable data on RDN have been obtained from Western populations, while the clinical outcomes of RDN in East Asian populations are seldom reported. Therefore, the purpose was to evaluate 6-month outcomes of RDN for the treatment of resistant hypertension in Chinese patients.In a prospective single-center cohort study, 50 Chinese patients with resistant hypertension would be recruited to undergo RDN by LEPU Renal denervation system, which was similar to Symplicity the Symplicity renal-denervation system (Medtronic). The primary effectiveness endpoint was change in systolic and diastolic blood pressure at six months as measured by office-based blood pressure assessment and 24-hour ambulatory blood pressure monitoring following therapeutic renal denervation compared to baseline. The primary safety endpoint was the incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%) that required stenting or surgery, cerebrovascular accident, myocardial infarction, death.

Being tested
LEPU Renal Denervation System
Medical subject headings
Hypertension, Cardiovascular Diseases, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LEPU Renal Denervation SystemDevice

    LEPU Renal denervation system was similar to Symplicity Catheter System (Medtronic Inc.)

Study groups in NCT02536326
Study groupRoleWhat they receive
renal denervationExperimentalNot described
Receives: Device: LEPU Renal Denervation System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy: Reduction of systolic blood pressure(SBP) and diastolic blood pressure(DBP) at six months as measured by office-based blood pressure assessment and ambulatory blood pressure monitoring(ABPM) compared to baseline

    Measured: 6 months after RDN

  2. 2.Safety: The incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%)

    Measured: through 6 months

Secondary outcomes (6)

  1. Reduction in 24-h ambulatory blood pressure(ABPM) parameters

    Measured: 1 month,3 months,6 months after RDN

  2. Device or procedure related acute adverse events（Renal artery edema、mural thrombus，change in transcatheter blood pressure >20%,<20% compared to baseline、reduction of heart rate >20%）

    Measured: Perioperative period

  3. Symptomatic orthostatic hypotension, hypertensive emergency necessitating hospital admission

    Measured: 1 month,3 months,6 months after RDN

  4. Change in office SBP and DBP at 1, 3 months

    Measured: 1 month, 3 months after RDN

  5. Change in average 24-hour SBP and DBP by ambulatory blood pressure monitoring (ABPM) at 1, 3 months

    Measured: 1 month, 3 months after RDN

  6. Change in renal function at 6 months: Estimated glomerular filtration rate (eGFR) reduction >25%, 50%

    Measured: 6 months after RDN

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2015 (estimated)
  2. Study startNov 2012
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02536326
Sponsor's protocol ID
2012-ZX-028
Acronym
LEPU-RDN
Status last verified
Aug 2015
First submitted
27 Aug 2015
Last updated
2 Sep 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LEPU Renal Denervation System in people with Hypertension and Cardiovascular Diseases, run by Lepu Medical Technology (Beijing) Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy: Reduction of systolic blood pressure(SBP) and diastolic blood pressure(DBP) at six months as measured by office-based blood pressure assessment and ambulatory blood pressure monitoring(ABPM) compared to baseline (time frame: 6 months after RDN). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02536326.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.

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LEPU-RDN Clinical Trial NCT02536326 | AzTrials