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Renal Fractional Flow Reserve in Renal Artery Stenting (PREFFER)

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ClinicalTrials.gov Identifier: NCT01128933
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : May 24, 2010
Information provided by:

Study Description
Brief Summary:
The purpose of the study is to determine potential utility of renal fractional flow reserve in prognosis predicting after renal stent implantation.

Condition or disease Intervention/treatment
Renal Artery Stenosis Hypertension Procedure: Renal artery stenting

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prognostic Value of Renal Fractional Flow Reserve in Hypertensive Patients With Renal Artery Stenosis Qualified to Renal Artery Stenting
Study Start Date : June 2006
Primary Completion Date : December 2009
Study Completion Date : May 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: Hypertensive patients
Hypertensive patients with at least moderate renal artery stenosis
Procedure: Renal artery stenting

Outcome Measures

Primary Outcome Measures :
  1. Blood pressure improvement [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Kidney function preservation [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least moderate (60% or more) renal artery stenosis with atheromatic appearance in angiography
  • Hypertension defined according to WHO criteria
  • Age 18-75 years
  • Signed informed consent obtained

Exclusion Criteria:

  • Bilateral renal artery stenosis or significant renal artery stenosis in solitary kidney
  • Contraindications to percutaneous renal angioplasty with stenting
  • Atrophy of the kidney supplied with stenosed artery
  • Other well known secondary reason for hypertension
  • Chronic heart failure NYHA II-IV
  • Significant valvular heart disease qualified for surgery
  • Persistent atrial fibrillation
  • Renal failure with GFR below 30ml/min
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01128933

Institute of Cardiology
Warsaw, Poland, 04-628
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Ministry of Science and Higher Education, Poland
Principal Investigator: Jacek Kadziela, MD,PhD Institute of Cardiology, Warsaw, Poland
Principal Investigator: Adam Witkowski, Prof Institute of Cardiology, Warsaw, Poland
Principal Investigator: Andrzej Januszewicz, Prof Institute of Cardiology, Warsaw, Poland
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jacek Kadziela, Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT01128933     History of Changes
Other Study ID Numbers: 2P05B02530
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: May 24, 2010
Last Verified: May 2010

Keywords provided by Institute of Cardiology, Warsaw, Poland:
Fractional flow reserve

Additional relevant MeSH terms:
Constriction, Pathologic
Renal Artery Obstruction
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases