Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease

NCT02863510 | Completed

• 1 other identifier: 2012138RN
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A pilot, single-center, prospective, interventional study. The objective is to demonstrate that catheter-based renal denervation using carbon dioxide renal angiography in patients with moderate to severe chronic kidney disease can be performed for treatment of uncontrolled hypertension.

Conditions

Hypertension; Chronic Kidney Disease

Keywords

Carbon dioxide angiography; Renal sympathetic denervation; Uncontrolled hypertension; Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Change in Estimated glomerular filtration rate from baseline to 7 days and 30 days

  Change in eGFR from baseline to 7 days and 1 month as measure of safety in terms of kidney function

  at baseline, 7days and 30 days

Secondary Outcomes (4)

• Change in estimated glomerular filtration rate from baseline to 7 days, 1, 3, and 6 months

  at baseline, 7 days, 1, 3, and 6 months

• Change in proteinuria (albumin:creatinine ratio) from baseline to at 1, 3, and 6 months.

  at baseline, 1, 3, and 6 months

• Change in mean daytime ambulatory blood pressure on 24 hour monitoring from baseline to 6 months

  at baseline and 6 months

• Change in office blood pressure from baseline to 1,3, and 6 months

  at baseline, 1, 3, and 6 months

Study Arms (1)

Renal Denervation

EXPERIMENTAL

Participation receiving renal sympathetic denervation

Device: Renal Sympathetic Denervation

Interventions

Renal Sympathetic Denervation DEVICE

Renal sympathetic denervation is a minimally invasive, endovascular catheter-based procedure using radiofrequency ablation of sympathetic nerves located in the walls of renal arteries, aimed at treating treatment-resistant hypertension.

Renal Denervation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-75 years with a clinic systolic blood pressure of 140 mm Hg or more despite compliance with three or more antihypertensive drugs,
• eGFR\<45 and \>15 mL/min per 1.73 m².

You may not qualify if:

• eGFR \<15 mL/min per 1.73 m²,
• Type 1 diabetes,
• Substantial stenotic valvular heart disease,
• Pregnancy or planned pregnancy during the study,
• A history of myocardial infarction, unstable angina, or cerebrovascular accident in the previous 6 months.

Sponsors & Collaborators

• Heart of England NHS Trust: lead

Study Sites (1)

Heart of England NHS Foundation Trust

Birmingham, West Midlands, B9 5SS, United Kingdom

Location

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Indranil Dasgupta, DM

  Heart of England NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: August 11, 2016
• Study Start: September 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)