Back to resultsRenal Fractional Flow Reserve in Renal Artery Stenting (PREFFER)
Primary Purpose
Renal Artery Stenosis, Hypertension
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Renal artery stenting
Sponsored by
About this trial
This is an interventional treatment trial for Renal Artery Stenosis focused on measuring Fractional flow reserve, Revascularization, Prognosis, Hemodynamics, Hypertension
Eligibility Criteria
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
Sites / Locations
- Institute of Cardiology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypertensive patients
Arm Description
Hypertensive patients with at least moderate renal artery stenosis
Outcomes
Primary Outcome Measures
Blood pressure improvement
Secondary Outcome Measures
Kidney function preservation
Full Information
NCT ID
NCT01128933
First Posted
May 21, 2010
Last Updated
May 21, 2010
Sponsor
National Institute of Cardiology, Warsaw, Poland
Collaborators
Ministry of Science and Higher Education, Poland
1. Study Identification
Unique Protocol Identification Number
NCT01128933
Brief Title
Renal Fractional Flow Reserve in Renal Artery Stenting
Acronym
PREFFER
Official Title
Prognostic Value of Renal Fractional Flow Reserve in Hypertensive Patients With Renal Artery Stenosis Qualified to Renal Artery Stenting
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland
Collaborators
Ministry of Science and Higher Education, Poland
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Artery Stenosis, Hypertension
Keywords
Fractional flow reserve, Revascularization, Prognosis, Hemodynamics, Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypertensive patients
Arm Type
Experimental
Arm Description
Hypertensive patients with at least moderate renal artery stenosis
Intervention Type
Procedure
Intervention Name(s)
Renal artery stenting
Primary Outcome Measure Information:
Title
Blood pressure improvement
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Kidney function preservation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Kadziela, MD,PhD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Witkowski, Prof
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrzej Januszewicz, Prof
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Cardiology
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
25268986
Citation
Kadziela J, Prejbisz A, Michalowska I, Adamczak M, Warchol-Celinska E, Pregowska-Chwala B, Januszewicz M, Wiecek A, Januszewicz A, Witkowski A. Relationship between hemodynamic parameters of renal artery stenosis and the changes of kidney function after renal artery stenting in patients with hypertension and preserved renal function. Blood Press. 2015 Feb;24(1):30-4. doi: 10.3109/08037051.2014.958304. Epub 2014 Sep 30.
Results Reference
derived
PubMed Identifier
23913461
Citation
Kadziela J, Januszewicz A, Prejbisz A, Michalowska I, Januszewicz M, Florczak E, Kalinczuk L, Norwa-Otto B, Warchol E, Witkowski A. Prognostic value of renal fractional flow reserve in blood pressure response after renal artery stenting (PREFER study). Cardiol J. 2013;20(4):418-22. doi: 10.5603/CJ.2013.0101.
Results Reference
derived
Links:
URL
http://www.ikard.pl
Description
Web page of Institute of Cardiology, Warsaw
Learn more about this trial
Renal Fractional Flow Reserve in Renal Artery Stenting
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