- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01887067
Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus (HTN2DM)
November 15, 2022 updated by: Kin Lam TSUI, Pamela Youde Nethersole Eastern Hospital
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 Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, Hong Kong
- Pamela Youde Nethersole Eastern Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Renal denervation therapy
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in office systolic & diastolic blood pressure from baseline to 6 months
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in office systolic and diastolic blood pressure up to 3 years
Time Frame: 3 years
|
3 years
|
|
Change in insulin sensitivity
Time Frame: 12 months
|
HOMA-IR index at baseline, 3-month and 12-month
|
12 months
|
Change in glucose metabolism
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kin Lam Tsui, FRCP (Edin, Glasg), Pamela Youde Nethersole Eastern Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
May 30, 2022
Study Completion (Actual)
May 30, 2022
Study Registration Dates
First Submitted
June 24, 2013
First Submitted That Met QC Criteria
June 25, 2013
First Posted (Estimate)
June 26, 2013
Study Record Updates
Last Update Posted (Actual)
November 18, 2022
Last Update Submitted That Met QC Criteria
November 15, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKEC-2012-038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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