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Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy (TreatDialRDN)

T

Turku University Hospital (TYKS)

Status

Terminated

Conditions

Hypertension Secondary to Renal Disease

Treatments

Procedure: Renal nerve denervation

Study type

Interventional

Funder types

Other

Identifiers

NCT01881035
VCH Heart Station 10
TreatDialRDN (II) (Other Identifier)

Details and patient eligibility

About

The study is designed to investigate the efficacy of renal nerve denervation in treating drug-resistant hypertension in patients with end stage renal disease.

Full description

Drug resistant hypertension is very common in end stage renal disease treated by dialysis. The prevalence of hypertension has been evaluated to be over 50% and up 80%. In this patient group mortality figures are high because of cardiovascular diseases which are complications of hypertension. Renal nerve denervation is a new intervention to treat hypertension. By applying radiofrequency pulses to the renal arteries, the nerves in the vascular wall (adventitia layer) can be denervated. This causes reduction of renal sympathetic afferent and efferent activity and blood pressure can be decreased. The technique and its efficacy in end stage renal disease has not been systematically studied. There are case reports which have showed promising responses to denervation. In the present study 30 patients over 18 years are planned undergo renal denervation if the medical treatment (three different drugs including diuretics) has failed to decrease blood pressure sufficiently(160/100mmHg). The failure of medical treatment will be documented by ambulatory blood pressure measurements. After renal nerve denervation a two year follow-up of patients with ambulatory blood pressure measurements will be organized. The blood pressures before and after denervation are compared and the quality of life of the patients is evaluated by questionnaires.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with end stage renal disease and drug-resistant blood pressure.

Exclusion criteria

  • pregnancy
  • secondary hypertension
  • unstable coronary artery disease

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Renal nerve denervation
Experimental group
Description:
Renal nerve denervation
Treatment:
Procedure: Renal nerve denervation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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