Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus

NCT ID: NCT01887067

Last Updated: 2022-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2022-05-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal denervation therapy

Group Type: EXPERIMENTAL

Renal denervation therapy

Intervention Type: PROCEDURE

Interventions

Renal denervation therapy

Intervention Type: PROCEDURE

Other Intervention Names

Renal denervation using Symplicity® Catheter System™

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamela Youde Nethersole Eastern Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kin Lam TSUI

Consultant Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kin Lam Tsui, FRCP (Edin, Glasg)

Role: PRINCIPAL_INVESTIGATOR

Pamela Youde Nethersole Eastern Hospital

Locations

Pamela Youde Nethersole Eastern Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

HKEC-2012-038

Identifier Type: -

Identifier Source: org_study_id