Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

— HTN2DM  

Official title:

Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01887067
• Other study ID #: HKEC-2012-038
• Status: Terminated
• Phase: N/A
• Start date: June 2013
• Est. completion date: May 30, 2022

Study information

• Verified date: November 2022
• Source: Pamela Youde Nethersole Eastern Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Hypertension, Resistant
• Renal Denervation Therapy

Intervention

Procedure:
• Renal denervation therapy

Locations

Country	Name	City	State
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Pamela Youde Nethersole Eastern Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in office systolic & diastolic blood pressure from baseline to 6 months		6 months
Secondary	Change in office systolic and diastolic blood pressure up to 3 years		3 years
Secondary	Change in insulin sensitivity	HOMA-IR index at baseline, 3-month and 12-month	12 months
Secondary	Change in glucose metabolism		3 years