Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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

Official Title
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Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus

Conditions
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Hypertension, Resistant, Diabetes Mellitus, Renal Denervation Therapy

Intervention / Treatment
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* Procedure: Renal denervation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal denervation therapy<br> | Procedure: Renal denervation therapy<br> <br> * Other names: Renal denervation using Symplicity® Catheter System™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in office systolic & diastolic blood pressure from baseline to 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in office systolic and diastolic blood pressure up to 3 years |  | 3 years | 
| Change in insulin sensitivity | HOMA-IR index at baseline, 3-month and 12-month | 12 months | 
| Change in glucose metabolism |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Diabetes Mellitus