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

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ClinicalTrials.gov Identifier: NCT01887067
Recruitment Status : Recruiting
First Posted : June 26, 2013
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Kin Lam TSUI, Pamela Youde Nethersole Eastern Hospital

Tracking Information
First Submitted Date  ICMJE June 24, 2013
First Posted Date  ICMJE June 26, 2013
Last Update Posted Date November 13, 2020
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Change in office systolic & diastolic blood pressure from baseline to 6 months [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • Change in office systolic and diastolic blood pressure up to 3 years [ Time Frame: 3 years ]
  • Change in insulin sensitivity [ Time Frame: 12 months ]
    HOMA-IR index at baseline, 3-month and 12-month
  • Change in glucose metabolism [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus
Official Title  ICMJE Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension, Resistant
  • Diabetes Mellitus
  • Renal Denervation Therapy
Intervention  ICMJE Procedure: Renal denervation therapy
Other Name: Renal denervation using Symplicity® Catheter System™
Study Arms  ICMJE Experimental: Renal denervation therapy
Intervention: Procedure: Renal denervation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kin Lam Tsui, FRCP (Edin, Glasg) +852 25956412 tsuikl1@ha.org.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01887067
Other Study ID Numbers  ICMJE HKEC-2012-038
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kin Lam TSUI, Pamela Youde Nethersole Eastern Hospital
Study Sponsor  ICMJE Pamela Youde Nethersole Eastern Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kin Lam Tsui, FRCP (Edin, Glasg) Pamela Youde Nethersole Eastern Hospital
PRS Account Pamela Youde Nethersole Eastern Hospital
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP