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NCT02608632 Clinical Trial

HFS-guided Renal Ablation for Improving Outcome of Renal Denervation Procedure

Hypertension Clinical Trial

Official title:
High Frequency Guided Renal Artery Denervation for Improving Outcome of Renal Ablation Procedure

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02608632
Other study ID # 7452RDNHFS
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received November 17, 2015
Last updated November 19, 2015
Start date February 2013
Est. completion date February 2016

Study information
Verified date November 2015
Source Meshalkin Research Institute of Pathology of Circulation
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial Summary

To increase the number of responders using HFS-guided renal artery denervation (RDN) in patients with resistant and moderate resistant hypertension

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 170
Est. completion date February 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Office-based systolic blood pressure of =140/90 mm Hg and <160/100 mm Hg (moderate resistant hypertension) or =160/100 mm Hg (severe resistant hypertension), despite treatment with 3 antihypertensive drugs (including a diuretic).

- A glomerular filtration rate =45 mL/min/1ยท73 m2, with modification of diet using a renal disease formula.

Exclusion Criteria:

- Secondary causes of hypertension

- Severe renal artery stenosis or dual renal arteries

- Congestive heart failure

- Left ventricular ejection fraction <35%

- Previous renal artery stenting or angioplasty

- Type 1 diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Renal denervation guided by HFS

• Renal denervation as standard procedure

Locations
Country Name City State
Russian Federation Federal Center of Cardiovascular surgery Krasnoyarsk
Russian Federation Regional Hospital Krasnoyarsk
Russian Federation Federal Center of Prophylactic Medicine Moscow

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of responders to renal denervation procedure 12 month Yes
Secondary complications rate 12 month Yes
Secondary cross-over rate 12 month Yes
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