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Completed

NCT Number: NCT02863510

Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart of England NHS Foundation Trust

Birmingham, West Midlands, B9 5SS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: at baseline, 7days and 30 days

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

Secondary outcomes

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

    Time frame: at baseline, 7 days, 1, 3, and 6 months

    Change in kidney function from baseline to 7 days, 1, 3, and 6 months

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

    Time frame: at baseline, 1, 3, and 6 months

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

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

    Time frame: at baseline and 6 months

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

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

    Time frame: at baseline, 1, 3, and 6 months

    Change in office BP from baseline to 1,3, and 6 months for efficacy

Sponsors and collaborators

Lead sponsor

Heart of England NHS Trust

Other

Registry information

Official study title

Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease Using a Novel Non-iodinated Contrast Free Protocol

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 11, 2016
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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