Clinical trial NCT02863510: Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease
Official title: Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease Using a Novel Non-iodinated Contrast Free Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Chronic Kidney Disease
Keywords: Carbon dioxide angiography
Renal sympathetic denervation
Uncontrolled hypertension
Chronic kidney disease
Lead sponsor: Heart of England NHS Trust
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Renal sympathetic denervation has been shown to be safe and effective in patients with uncontrolled hypertension and estimated Glomerular Filtration Rate (eGFR)\>45 mL/min per 1•73 m². However, the safety and efficacy of this has not been studied in patients with more severe renal impairment. The investigators aim to examine safety and efficacy of renal denervation (RDN) in patients with eGFR between 44 and 15 ml/min/1.73 m2 (CKD 3b \& 4) in a pilot study which may be a precursor of a large observational study in the future. Moreover, the current imaging protocol and procedure protocol for renal sympathetic denervation requires the use of iodinated contrast, which can have deleterious effects on renal function. The investigators have a proven track record for the use of carbon dioxide angiography in renal artery intervention. The investigators would like to use carbon dioxide angiography in this study to minimize contrast induced deterioration in renal function in this cohort which may again be a precursor of a farther larger study.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Estimated glomerular filtration rate from baseline to 7 days and 30 days
timeFrame: at baseline, 7days and 30 days
Secondary outcomes:
measure: Change in estimated glomerular filtration rate from baseline to 7 days, 1, 3, and 6 months
timeFrame: at baseline, 7 days, 1, 3, and 6 months
measure: Change in proteinuria (albumin:creatinine ratio) from baseline to at 1, 3, and 6 months.
timeFrame: at baseline, 1, 3, and 6 months
measure: Change in mean daytime ambulatory blood pressure on 24 hour monitoring from baseline to 6 months
timeFrame: at baseline and 6 months
measure: Change in office blood pressure from baseline to 1,3, and 6 months
timeFrame: at baseline, 1, 3, and 6 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust
state: West Midlands
Study officials:
affiliation: Heart of England NHS Foundation Trust
name: Indranil Dasgupta, DM
role: PRINCIPAL_INVESTIGATOR
References: