Status:
TERMINATED
Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus
Lead Sponsor:
Pamela Youde Nethersole Eastern Hospital
Conditions:
Hypertension, Resistant
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01887067
Start Date
June 1 2013
End Date
May 30 2022
Last Update
November 18 2022
Active Locations (1)
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1
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong