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

This study is currently recruiting participants.
Verified June 2013 by Pamela Youde Nethersole Eastern Hospital
Sponsor:
Information provided by (Responsible Party):
Kin Lam TSUI, Pamela Youde Nethersole Eastern Hospital
ClinicalTrials.gov Identifier:
NCT01887067
First received: June 24, 2013
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Hypertension, Resistant
Diabetes Mellitus
Renal Denervation Therapy
Procedure: Renal denervation therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Pamela Youde Nethersole Eastern Hospital:

Primary Outcome Measures:
  • Change in office systolic & diastolic blood pressure from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in office systolic and diastolic blood pressure up to 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Change in insulin sensitivity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    HOMA-IR index at baseline, 3-month and 12-month

  • Change in glucose metabolism [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: June 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal denervation therapy Procedure: Renal denervation therapy
Other Name: Renal denervation using Symplicity® Catheter System™

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01887067

Contacts
Contact: Kin Lam Tsui, FRCP (Edin, Glasg) +852 25956412 tsuikl1@ha.org.hk

Locations
Hong Kong
Pamela Youde Nethersole Eastern Hospital Recruiting
Hong Kong, Hong Kong
Contact: Kin Lam Tsui, FRCP (Edin, Glasg)    +852 25956412    tsuikl1@ha.org.hk   
Sponsors and Collaborators
Pamela Youde Nethersole Eastern Hospital
Investigators
Principal Investigator: Kin Lam Tsui, FRCP (Edin, Glasg) Pamela Youde Nethersole Eastern Hospital
  More Information

No publications provided

Responsible Party: Kin Lam TSUI, Consultant Physician, Pamela Youde Nethersole Eastern Hospital
ClinicalTrials.gov Identifier: NCT01887067     History of Changes
Other Study ID Numbers: HKEC-2012-038
Study First Received: June 24, 2013
Last Updated: June 25, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Pamela Youde Nethersole Eastern Hospital:
Hypertension
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014