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Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00753116
Enrollment
20
Registered
2008-09-16
Start date
2008-09-30
Completion date
2009-12-31
Last updated
2012-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic, Renal Dialysis

Brief summary

The purpose of this this study is to investigate the clinical utility of renal denervation in the treatment of ESRD patients with refractory hypertension.

Interventions

DEVICERenal Denervation with a catheter-based procedure

Disruption of the renal nerves with a catheter-based procedure

Sponsors

Medtronic Vascular
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Systolic blood pressure of 160 mmHg or greater * On 3 or more antihypertensive medications * On dialysis for more than 6 months

Exclusion criteria

* Renal artery abnormalities * Known secondary hypertension attributable to a cause other than sleep apnea * MI, angina, CVA within 6 months * Others

Design outcomes

Primary

MeasureTime frame
Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.Through 1 year

Secondary

MeasureTime frame
Physiologic response to denervation (e.g., blood pressure reduction)Through 1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026