Renal Denervation in Refractory Hypertension (PRAGUE-15)
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|ClinicalTrials.gov Identifier: NCT01560312|
Recruitment Status : Terminated (Based on analysis of our data after the Symplicity-3 trial announcement, decision for study termination was done.)
First Posted : March 22, 2012
Last Update Posted : March 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Resistant to Conventional Therapy||Device: Renal denervation (Symplicity® Catheter System™)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Renal Denervation - Hope for Patients With Refractory Hypertension?|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Renal denervation
Renal denervation + conventional antihypertensive medical treatment without spironolactone (spironolactone can be taken only if started before randomization)
Device: Renal denervation (Symplicity® Catheter System™)
4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic)
No Intervention: Medical treatment
Conventional antihypertensive treatment including spironolactone (if not contraindicated).
One year after randomization, renal denervation can be performed according to the physician's decision based on the BP levels and if patient desires the procedure.
- Blood pressure difference [ Time Frame: 6 months ]Systolic and Diastolic blood pressure difference between baseline and 6 months post-randomization. Blood pressure will be evaluated using 24-hours monitoring.
- Blood pressure differences similar to primary outcome [ Time Frame: 1 year, 2 years, 3 years ]Systolic and Diastolic BP differences (comparison between baseline and evaluated time period) will be measured using 24-hours monitoring and also at office.
- Change of blood laboratory parameters and renal function [ Time Frame: 6 months, 1, 2, 3 years ]changes in blood concentrations of renin, aldosterone, metanephrines and renal function
- Post-denervation renal anatomy assessment [ Time Frame: 1 year ]CT angiography will be performed 1 year after RDN
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): NCT01560312
|Cardiocenter, University Hospital Olomouc|
|Olomouc, Czech Republic|
|Prague, Czech Republic|
|Trinec, Czech Republic|
|Principal Investigator:||Petr Widimsky, Prof, MD||Charles University, Prague, Czech Republic|
|Principal Investigator:||Jiri Widimsky, Prof.MD.||General University Hospital|