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Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease

B

Baker Heart and Diabetes Institute

Status

Completed

Conditions

Hypertension
End-stage Renal Disease

Treatments

Procedure: Renal Denervation

Study type

Interventional

Funder types

Other

Identifiers

NCT02021019
1052470 (Other Grant/Funding Number)
527/13

Details and patient eligibility

About

Sympathetic activation is a hallmark of end-stage renal disease and adversely affects cardiovascular prognosis. Hypertension is present in the vast majority of these patients and plays a key role in the progressive deterioration of renal function and in the exceedingly high rate of cardiovascular events. Selective catheter-based renal denervation has been shown to be safe and effective in attaining improved and sustained blood pressure control in patients with resistant hypertension and normal renal function. The investigators hypothesize that catheter-based renal denervation is a safe and effective intervention to achieve sustained reduction in sympathetic nerve activity, BP and target organ damage in hypertensive End-Stage Renal Disease (ESRD) patients, which will result in improved cardiovascular outcomes.

Enrollment

3 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • end stage renal disease
  • hypertension (BP≥140/90mmHg)

Exclusion criteria

  • Individual has renal artery anatomy that is ineligible for treatment as assessed by the interventionalist.
  • Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3 participants in 2 patient groups

Renal Denervation
Experimental group
Description:
Renal denervation using a catheter-based Radio-frequency approach
Treatment:
Procedure: Renal Denervation
Usual Care
No Intervention group
Description:
Usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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