Renal Denervation in Refractory Hypertension (PRAGUE-15)

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. 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
General University Hospital, Prague
University Hospital Olomouc
Cardiocenter Podlesí, Trinec, Czech Republic
Information provided by (Responsible Party):
Petr Widimsky, MD, Charles University, Czech Republic

Brief Summary:
Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic. Patients with refractory hypertension will be randomized in 1:1 manner either to renal denervation plus optimal medical antihypertensive treatment without spironolactone or to antihypertensive treatment alone including spironolactone if not contraindicated. The primary end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline and 1 year after randomization evaluated by 24-hours BP monitoring. Expected enrollment is 120 patients. Patients follow-up is planned for 3 years.

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Post-denervation renal anatomy assessment [ Time Frame: 1 year ]
    CT angiography will be performed 1 year after RDN

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

Inclusion Criteria:

  • Refractory hypertension with office SBP > 140 mmHg
  • SBP > 130 during 24-hours Holter blood pressure monitoring
  • Treatment with the least 3 antihypertensive medications including diuretics in optimal doses
  • Age > 18 years
  • Signed informed consent

Exclusion Criteria:

  • Secondary forms of hypertension
  • Chronic renal disease (serum creatinine > 200 umol/l)
  • Pregnancy
  • History of myocardial infarction or stroke in last 6 months
  • Severe valvular stenotic disease
  • Anatomic abnormalities and variants of renal artery including aneurysms, severe stenosis, reference diameter < 4 mm or length < 20 mm
  • Increased bleeding risk (thrombocytopenia < 50, INR > 1.5)

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 identifier (NCT number): NCT01560312

Czech Republic
Cardiocenter, University Hospital Olomouc
Olomouc, Czech Republic
Jiri Widimsky
Prague, Czech Republic
Cardiocenter Podlesi
Trinec, Czech Republic
Sponsors and Collaborators
Charles University, Czech Republic
General University Hospital, Prague
University Hospital Olomouc
Cardiocenter Podlesí, Trinec, Czech Republic
Principal Investigator: Petr Widimsky, Prof, MD Charles University, Prague, Czech Republic
Principal Investigator: Jiri Widimsky, Prof.MD. General University Hospital

Responsible Party: Petr Widimsky, MD, Head of Cardiocenter, 3rd Faculty of Medicine, Charles University, Czech Republic Identifier: NCT01560312     History of Changes
Other Study ID Numbers: Charles University
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: February 2014

Keywords provided by Petr Widimsky, MD, Charles University, Czech Republic:
Renal denervation
Resistant hypertension
Long-term Outcome

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents