HypertensionNCT02672462

Renal Denervation for the Treatment of Hypertension: A Pilot Safety and Efficacy Study

A study testing Radio frequency renal denervation system (Golden Leaf GL-06E15A) in people with Hypertension, run by Shanghai Golden Leaf MedTec Co. Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

A single center, self-controlled pilot study on safety and efficacy of renal denervation in treatment of hypertension. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hypertension
What is being tested?: Radio frequency renal denervation system (Golden Leaf GL-06E15A)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: Dec 2015to Jun 2016
Phase: Interventional
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ages of 18 to 75, male or female;
Main renal artery, with or without accessary renal arteries, with length
20mm;
Patients who have not taken any anti-hypertensive drugs or have been off drugs for at least 2 weeks, with mean SBP ≥150mmHg and
180mmHg based on at least 3 office blood pressure measurements, or ASBP≥135mmHg and ≤170mmHg based on 24 hr blood pressure monitoring;
Agrees to take part in the trial and signs the written, informed consent.

Who cannot join

Renal artery abnormalities that are inappropriate for the procedure;
Pregnant or plan to become pregnant;
History of orthostatic hypotension;
Type I diabetes;
Estimated GFR<40mL/min/1.73m2;
Only one kidney or prior kidney transplantation;

Show all 14Show fewer

Bleeding tendency or other coagulation related diseases;
Acute or severe systemic infection;
Prior renal artery interventional procedures or prior RDN treatment;
History of stroke or TIA;
Malignant tumor or end-stage illnesses;
Secondary hypertension;
Acute coronary events within 2 weeks;
Other conditions that deem unsuitable for the procedure, in the opinions of investigators.

Trial locations and contacts

1 site in 1 country.

Gengshan Ma, MD contact

(86)13002580569

China1 site, 1 recruiting

Zhongda Hospital
Nanjing, Jiangsu
Gengshan Ma, MD, (86)13002580569
Recruiting

Other trials in China

About this study

Official title: The Safety and Efficacy of a Renal Denervation System in Treating Patients With Hypertension: A Pilot Study

A single center, self-controlled pilot study on safety and efficacy of renal denervation in treatment of hypertension.

Conditions: Hypertension
Being tested: Radio frequency renal denervation system (Golden Leaf GL-06E15A)
Medical subject headings: Hypertension

What participants receive

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

Radio frequency renal denervation system (Golden Leaf GL-06E15A)Device

Study groups in NCT02672462
Study group	Role	What they receive
Renal denervation	Experimental	Not described Receives: Device: Radio frequency renal denervation system (Golden Leaf GL-06E15A)

What is being measured

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

blood pressure
Measured: 6 months

Timeline

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

Dec 2015Jun 2016

First posted3 Feb 2016 (estimated)
Study startDec 2015
Primary completionJun 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02672462
Sponsor's protocol ID: GL-CT-20150301
Status last verified: Feb 2016
First submitted: 1 Feb 2016
Last updated: 4 Feb 2016
Results posted: No

Want to know more?

Gengshan Ma, MD

(86)13002580569

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Safety and Efficacy of a Renal Denervation System in Treating Patients With Hypertension: A Pilot Study
ClinicalTrials.gov ID: NCT02672462
Acronym / sponsor ID: GL-CT-20150301
Conditions: Hypertension
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 20 participants (estimated)
Lead sponsor: Shanghai Golden Leaf MedTec Co. LtdIndustry (pharma, biotech, devices)
Study start: Dec 2015
Primary completion: Jun 2016 (estimated)
First posted: 3 Feb 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A single center, self-controlled pilot study on safety and efficacy of renal denervation in treatment of hypertension.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Renal denervation	Experimental	Device: Radio frequency renal denervation system (Golden Leaf GL-06E15A)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Ages of 18 to 75, male or female;
Main renal artery, with or without accessary renal arteries, with length
Patients who have not taken any anti-hypertensive drugs or have been off drugs for at least 2 weeks, with mean SBP ≥150mmHg and
Agrees to take part in the trial and signs the written, informed consent.

Key exclusion criteria (14 listed)

Renal artery abnormalities that are inappropriate for the procedure;
Pregnant or plan to become pregnant;
History of orthostatic hypotension;
Type I diabetes;
Estimated GFR<40mL/min/1.73m2;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radio frequency renal denervation system (Golden Leaf GL-06E15A)	Device	Renal denervation

Primary outcome

blood pressure
Time frame: 6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gengshan Ma, MD contact

(86)13002580569

Gengshan Ma, MD principal investigator

Cardiovascular division, Dept. of Internal Medicine, Zhongda Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Radio frequency renal denervation system (Golden Leaf GL-06E15A) in people with Hypertension, run by Shanghai Golden Leaf MedTec Co. Ltd at 1 site in China.

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 14 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: status not confirmed, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

Results are not available in the source record.

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

Contact Gengshan Ma, MD ((86)13002580569), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

blood pressure (time frame: 6 months). 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 NCT02672462.

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 4 Feb 2016.