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Renal Denervation in Refractory Hypertension (PRAGUE-15)

This study is currently recruiting participants.
Verified March 2012 by Charles University, Czech Republic
Sponsor:
Collaborators:
University Hospital Olomouc
Cardiocenter Podlesí, Trinec, Czech Republic
Information provided by (Responsible Party):
Petr Widimsky, MD, Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT01560312
First received: March 19, 2012
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

Open, multi-center, randomised 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 or to antihypertensive treatment alone. The primary end-point is change in Systolic Blood Pressure after 6 months post denervation. Expected enrollment is 150 patients. Patients follow-up is planned for 5 years.


Condition Intervention Phase
Hypertension, Resistant to Conventional Therapy
 Device: Renal denervation (Symplicity® Catheter System™)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Denervation - Hope for Patients With Refractory Hypertension?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • Blood pressure difference [ Time Frame: 6 months, 5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 6 months, 5 years ] [ Designated as safety issue: Yes ]
    Death, non-fatal myocardial infarction, stroke

  • Change of blood laboratory parameters [ Time Frame: 6 months, 5 years ] [ Designated as safety issue: No ]
    changes in blood concentrations of renin, aldosteron, metanephrines

  • Renal function changes [ Time Frame: 6 months, 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2011
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal denervation
Renal denervation + conventional antihypertensive medical treatment
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560312

Contacts
Contact: Petr Widimsky, Prof, MD 00420267163159 petr.widimsky@fnkv.cz

Locations
Czech Republic
Cardiocenter, University Hospital Olomouc Recruiting
Olomouc, Czech Republic
Contact: Milos Taborsky, Ass.Prof., MD            
Sub-Investigator: Milos Taborsky, Ass.Prof., MD            
Cardiocenter Podlesi Recruiting
Trinec, Czech Republic
Contact: Marian Branny, MD            
Sub-Investigator: Marian Branny, MD            
Sponsors and Collaborators
Charles University, Czech Republic
University Hospital Olomouc
Cardiocenter Podlesí, Trinec, Czech Republic
Investigators
Principal Investigator: Petr Widimsky, Prof, MD Charles University, Prague, Czech Republic
  More Information

No publications provided

Responsible Party: Petr Widimsky, MD, Head of Cardiocenter, 3rd Faculty of Medicine, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT01560312     History of Changes
Other Study ID Numbers: Charles University
Study First Received: March 19, 2012
Last Updated: March 21, 2012
Health Authority: Czech Republic: Ministry of Health

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013