Hypertension, ResistantHTN2DMNCT01887067
Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus
A study testing Renal denervation therapy in people with Hypertension, Resistant and Diabetes Mellitus, run by Pamela Youde Nethersole Eastern Hospital at 1 site in Hong Kong.
Trial summary
To demonstrate the efficacy of renal denervation therapy in treating resistant hypertension and its effect on glucose metabolism in patients with type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension, Resistant, Diabetes Mellitus, Renal Denervation Therapy
- What is being tested?
- Renal denervation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2013to 30 May 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranges from 18 to 70 years inclusive
- Essential hypertension
- Office Systolic BP (SBP) ≥ 150 mmHg or Diastolic BP (DBP) ≥ 90mmHg
- 3 or more anti-hypertensive medications of different classes, including a diuretic, or documented intolerance to multiple medications
- Type 2 Diabetes Mellitus on oral hypoglycaemic agent (OHA)
- 2 functional kidneys; eGFR ≥ 45 mL/min/1.73m² (MDRD formula)
- Suitable renal anatomy compatible with the endovascular denervation procedure
Who cannot join
- Individual has renal artery anatomy that is ineligible for treatment including:
- Patients with secondary hypertension
- Myocardial infarction, unstable angina pectoris, cerebrovascular accident within 6 months
- Patient with type 1 diabetes mellitus
- Patient on insulin due to oral drug failure
- Renovascular abnormalities (including severe renal artery stenosis, previous renal stenting or angioplasty, or known dual renal arteries)
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- Pregnancy
- Patient with any implantable device incompatible with radiofrequency energy delivery
- Hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous
- Any serious medical condition, which in the opinion of the investigator, may limit the life expectancy of patients or adversely
Trial locations and contacts
1 site in 1 country.
About this study
To demonstrate the efficacy of renal denervation therapy in treating resistant hypertension and its effect on glucose metabolism in patients with type 2 diabetes mellitus
- Being tested
- Renal denervation therapy
- Keywords
- Hypertension, Diabetes Mellitus
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervation therapyProcedure or surgery
Also called Renal denervation using Symplicity® Catheter System™
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation therapy | Experimental | Not described Receives: Procedure: Renal denervation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in office systolic & diastolic blood pressure from baseline to 6 months
Measured: 6 months
Secondary outcomes (3)
Change in office systolic and diastolic blood pressure up to 3 years
Measured: 3 years
Change in insulin sensitivity
HOMA-IR index at baseline, 3-month and 12-month
Measured: 12 months
Change in glucose metabolism
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completion30 May 2022
- Study completion30 May 2022
Why it stopped: Slow recruitment and change in clinical evidence
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, ResistantStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamela Youde Nethersole Eastern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kin Lam TSUI, Pamela Youde Nethersole Eastern Hospital
- Investigators
- Kin Lam Tsui, FRCP (Edin, Glasg), Principal investigator, Pamela Youde Nethersole Eastern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887067
- Sponsor's protocol ID
- HKEC-2012-038
- Acronym
- HTN2DM
- Status last verified
- Nov 2022
- First submitted
- 24 Jun 2013
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01887067
- Acronym / sponsor ID
- HTN2DM / HKEC-2012-038
- Keywords
- Hypertension, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment and change in clinical evidence
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Pamela Youde Nethersole Eastern HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 26 Jun 2013 (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.
To demonstrate the efficacy of renal denervation therapy in treating resistant hypertension and its effect on glucose metabolism in patients with type 2 diabetes mellitus
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 therapy | Experimental | Procedure: Renal denervation therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ranges from 18 to 70 years inclusive
- Essential hypertension
- Office Systolic BP (SBP) ≥ 150 mmHg or Diastolic BP (DBP) ≥ 90mmHg
- 3 or more anti-hypertensive medications of different classes, including a diuretic, or documented intolerance to multiple medications
- Type 2 Diabetes Mellitus on oral hypoglycaemic agent (OHA)
Key exclusion criteria (10 listed)
- Individual has renal artery anatomy that is ineligible for treatment including:
- Patients with secondary hypertension
- Myocardial infarction, unstable angina pectoris, cerebrovascular accident within 6 months
- Patient with type 1 diabetes mellitus
- Patient on insulin due to oral drug failure
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 |
|---|---|---|
| Renal denervation therapyAlso: Renal denervation using Symplicity® Catheter System™ | Procedure or surgery | Renal denervation therapy |
Primary outcome
Change in office systolic & diastolic blood pressure from baseline to 6 months
Time frame: 6 months
3 secondary outcomes
Change in office systolic and diastolic blood pressure up to 3 years
Time frame: 3 years
Change in insulin sensitivity
Time frame: 12 months
Change in glucose metabolism
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Slow recruitment and change in clinical evidence). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
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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.
Kin Lam Tsui, FRCP (Edin, Glasg) principal investigator
Pamela Youde Nethersole Eastern 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 Renal denervation therapy in people with Hypertension, Resistant and Diabetes Mellitus, run by Pamela Youde Nethersole Eastern Hospital at 1 site in Hong Kong.
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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 18 Nov 2022. 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 Hong Kong. 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?
The study was stopped early (reason given: Slow recruitment and change in clinical evidence). Results are not available in the source record.
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?
Change in office systolic & diastolic blood pressure from baseline to 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2022.