Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus

NCT01887067 | Terminated DMC

• 1 other identifier: HKEC-2012-038
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension, Resistant; Diabetes Mellitus; Renal Denervation Therapy

Keywords

Hypertension; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (3)

• Change in office systolic and diastolic blood pressure up to 3 years

  3 years

• Change in insulin sensitivity

  12 months

• Change in glucose metabolism

  3 years

Study Arms (1)

Renal denervation therapy

EXPERIMENTAL

Procedure: Renal denervation therapy

Interventions

Renal denervation therapy PROCEDURE

Also known as: Renal denervation using Symplicity® Catheter System™

Renal denervation therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ranges from 18 to 70 years inclusive
• Essential hypertension
• Office Systolic BP (SBP) ≥ 150 mmHg or Diastolic BP (DBP) ≥ 90mmHg
• 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)
• functional kidneys; eGFR ≥ 45 mL/min/1.73m² (MDRD formula)
• Suitable renal anatomy compatible with the endovascular denervation procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamela Youde Nethersole Eastern Hospital: lead

Study Sites (1)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kin Lam Tsui, FRCP (Edin, Glasg)

  Pamela Youde Nethersole Eastern Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: June 1, 2013
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

HK (1)