Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01887067

Acronym

HTN2DM

Enrollment

Registered

2013-06-26

Start date

2013-06-30

Completion date

2022-05-30

Last updated

2022-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Hypertension, Resistant, Renal Denervation Therapy

Keywords

Hypertension, Diabetes Mellitus

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

Interventions

PROCEDURERenal denervation therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in office systolic & diastolic blood pressure from baseline to 6 months	6 months

Secondary

Measure	Time frame	Description
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	—

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026