Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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:
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: September 22, 2016
Last verified: September 2016

June 14, 2013
September 22, 2016
May 2013
December 2016   (final data collection date for primary outcome measure)
Comparison of blood pressures before and after intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01881035 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Ouality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
12-lead ECG changes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
 
Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy
Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy
The study is designed to investigate the efficacy of renal nerve denervation in treating drug-resistant hypertension in patients with end stage renal disease.
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.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension Secondary to Renal Disease
Procedure: Renal nerve denervation
Renal nerve denervation is performed by catheter ablation of renal arteries influencing the sympathetic nerves.
Experimental: Renal nerve denervation
Renal nerve denervation
Intervention: Procedure: Renal nerve denervation
Pietilä-Effati PM, Salmela AK, Niemi RT, Ylitalo AS, Koistinen MJ. Renal sympathetic denervation in treating drug-resistant hypertension in a patient on hemodialysis. J Hypertens. 2016 Feb;34(2):368-70. doi: 10.1097/HJH.0000000000000802.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • secondary hypertension
  • unstable coronary artery disease
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01881035
VCH Heart Station 10, TreatDialRDN (II)
No
Not Provided
Not Provided
Juhani Koistinen, Turku University Hospital
Turku University Hospital
  • Oulu University Hospital
  • Satakunta Central Hospital
  • Central Finland Hospital District
  • Vaasa Central Hospital, Vaasa, Finland
Not Provided
Turku University Hospital
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP