Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01887067
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01887067
Study Brief:
Protocol Section:
NCT01887067