Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus (HTN2DM)

Pamela Youde Nethersole Eastern Hospital

Status

Terminated

Conditions

Renal Denervation Therapy

Diabetes Mellitus

Hypertension, Resistant

Treatments

Procedure: Renal denervation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01887067

HKEC-2012-038

Details and patient eligibility

About

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

Enrollment

7 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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