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

This study is currently recruiting participants.
Verified March 2016 by Kin Lam TSUI, Pamela Youde Nethersole Eastern Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01887067
First Posted: June 26, 2013
Last Update Posted: March 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kin Lam TSUI, Pamela Youde Nethersole Eastern Hospital
June 24, 2013
June 26, 2013
March 30, 2016
June 2013
June 2017   (Final data collection date for primary outcome measure)
Change in office systolic & diastolic blood pressure from baseline to 6 months [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01887067 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus
Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus
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
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypertension, Resistant
  • Diabetes Mellitus
  • Renal Denervation Therapy
Procedure: Renal denervation therapy
Other Name: Renal denervation using Symplicity® Catheter System™
Experimental: Renal denervation therapy
Intervention: Procedure: Renal denervation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
June 2018
June 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact: Kin Lam Tsui, FRCP (Edin, Glasg) +852 25956412 tsuikl1@ha.org.hk
Hong Kong
 
 
NCT01887067
HKEC-2012-038
Yes
Not Provided
Not Provided
Kin Lam TSUI, Pamela Youde Nethersole Eastern Hospital
Pamela Youde Nethersole Eastern Hospital
Not Provided
Principal Investigator: Kin Lam Tsui, FRCP (Edin, Glasg) Pamela Youde Nethersole Eastern Hospital
Pamela Youde Nethersole Eastern Hospital
March 2016

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