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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation | Experimental | Participation receiving renal sympathetic denervation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in estimated glomerular filtration rate from baseline to 7 days, 1, 3, and 6 months | Change in kidney function 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Indranil Dasgupta, DM | Heart of England NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart of England NHS Foundation Trust | Birmingham | West Midlands | B9 5SS | United Kingdom |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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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 | 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 | Change in office BP from baseline to 1,3, and 6 months for efficacy | at baseline, 1, 3, and 6 months |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |