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

This study is currently recruiting participants.
Verified June 2013 by Turku University Hospital
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01881035
First received: June 14, 2013
Last updated: June 27, 2013
Last verified: June 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Comparison of blood pressures before and after intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 12-lead ECG changes [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01881035

Contacts
Contact: Juhani Koistinen, MD +35863231111 juhani.koistinen@vshp.fi

Locations
Finland
Vaasa Central Hospital Recruiting
Vaasa, Finland, 65130
Contact: Juhani Koistinen, MD    +35863231111    juhani.koistinen@vshp.fi   
Contact: Päivi Pietilä-Effati, MD    +35863231111    paivi.pietila-effati@vshp.fi   
Principal Investigator: Juhani Koistinen, MD         
Sub-Investigator: Päivi Pietilä-Effati, MD         
Sponsors and Collaborators
Turku University Hospital
Oulu University Hospital
Satakunta Central Hospital
Central Finland Hospital District
Vaasa Central Hospital, Vaasa, Finland
  More Information

No publications provided

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)
Study First Received: June 14, 2013
Last Updated: June 27, 2013
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

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

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

ClinicalTrials.gov processed this record on April 17, 2014