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Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus (HTN2DM)

Primary Purpose

Hypertension, Resistant, Diabetes Mellitus, Renal Denervation Therapy

Status
Terminated
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Renal denervation therapy
Sponsored by
Pamela Youde Nethersole Eastern Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Resistant focused on measuring Hypertension, Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pamela Youde Nethersole Eastern Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal denervation therapy

Arm Description

Outcomes

Primary Outcome Measures

Change in office systolic & diastolic blood pressure from baseline to 6 months

Secondary Outcome Measures

Change in office systolic and diastolic blood pressure up to 3 years
Change in insulin sensitivity
HOMA-IR index at baseline, 3-month and 12-month
Change in glucose metabolism

Full Information

First Posted
June 24, 2013
Last Updated
November 15, 2022
Sponsor
Pamela Youde Nethersole Eastern Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01887067
Brief Title
Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus
Acronym
HTN2DM
Official Title
Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment and change in clinical evidence
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamela Youde Nethersole Eastern Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Resistant, Diabetes Mellitus, Renal Denervation Therapy
Keywords
Hypertension, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal denervation therapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Renal denervation therapy
Other Intervention Name(s)
Renal denervation using Symplicity® Catheter System™
Primary Outcome Measure Information:
Title
Change in office systolic & diastolic blood pressure from baseline to 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in office systolic and diastolic blood pressure up to 3 years
Time Frame
3 years
Title
Change in insulin sensitivity
Description
HOMA-IR index at baseline, 3-month and 12-month
Time Frame
12 months
Title
Change in glucose metabolism
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kin Lam Tsui, FRCP (Edin, Glasg)
Organizational Affiliation
Pamela Youde Nethersole Eastern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus

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