Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus

Not Applicable

Terminated

• Conditions: Diabetes Mellitus; Hypertension, Resistant; Renal Denervation Therapy
• Interventions: Procedure: Renal denervation therapy

• Registration Number: NCT01887067
• Lead Sponsor: Pamela Youde Nethersole Eastern Hospital

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 available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-26
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-15
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal denervation therapy	Renal denervation therapy	-

Primary Outcome Measures

Name	Time	Method
Change in office systolic & diastolic blood pressure from baseline to 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Change in office systolic and diastolic blood pressure up to 3 years	3 years
Change in insulin sensitivity	12 months	HOMA-IR index at baseline, 3-month and 12-month
Change in glucose metabolism	3 years

Trial Locations

Locations (1)

Pamela Youde Nethersole Eastern Hospital; 🇭🇰 Hong Kong, Hong Kong