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

This study has been terminated.
(Recruiting of the whole study population not possible.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01881035
First Posted: June 19, 2013
Last Update Posted: September 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Oulu University Hospital
Satakunta Central Hospital
Central Finland Hospital District
Vaasa Central Hospital, Vaasa, Finland
Information provided by (Responsible Party):
Juhani Koistinen, Turku University Hospital
  Purpose
The study is designed to investigate the efficacy of renal nerve denervation in treating drug-resistant hypertension in patients with end stage renal disease.

Condition Intervention
Hypertension Secondary to Renal Disease Procedure: Renal nerve denervation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy

Further study details as provided by Juhani Koistinen, Turku University Hospital:

Primary Outcome Measures:
  • Comparison of blood pressures before and after intervention [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2 years ]

Other Outcome Measures:
  • 12-lead ECG changes [ Time Frame: 2 years ]

Estimated Enrollment: 6
Study Start Date: May 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal nerve denervation
Renal nerve denervation
Procedure: Renal nerve denervation
Renal nerve denervation is performed by catheter ablation of renal arteries influencing the sympathetic nerves.

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • secondary hypertension
  • unstable coronary artery disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881035


Locations
Finland
Vaasa Central Hospital
Vaasa, Finland, 65130
Sponsors and Collaborators
Turku University Hospital
Oulu University Hospital
Satakunta Central Hospital
Central Finland Hospital District
Vaasa Central Hospital, Vaasa, Finland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juhani Koistinen, Professor in Medicine Turku University, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01881035     History of Changes
Other Study ID Numbers: VCH Heart Station 10
TreatDialRDN (II) ( Other Identifier: Turku University Finland )
First Submitted: June 14, 2013
First Posted: June 19, 2013
Last Update Posted: September 26, 2016
Last Verified: September 2016

Keywords provided by Juhani Koistinen, Turku University Hospital:
Hypertension
End stage renal disease

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Hypertension, Renal
Nephritis
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases