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

Conditions

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital

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
Procedure: Renal denervation therapy
Other Names:
  • Renal denervation using Symplicity® Catheter System™

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.

Sponsor

Pamela Youde Nethersole Eastern Hospital

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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