Renal Fractional Flow Reserve in Renal Artery Stenting
PREFFER
Prognostic Value of Renal Fractional Flow Reserve in Hypertensive Patients With Renal Artery Stenosis Qualified to Renal Artery Stenting
1 other identifier
interventional
45
1 country
1
Brief Summary
The purpose of the study is to determine potential utility of renal fractional flow reserve in prognosis predicting after renal stent implantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 21, 2010
CompletedFirst Posted
Study publicly available on registry
May 24, 2010
CompletedMay 24, 2010
May 1, 2010
3.5 years
May 21, 2010
May 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood pressure improvement
6 months
Secondary Outcomes (1)
Kidney function preservation
6 months
Study Arms (1)
Hypertensive patients
EXPERIMENTALHypertensive patients with at least moderate renal artery stenosis
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Cardiology
Warsaw, 04-628, Poland
Related Publications (2)
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.
PMID: 25268986DERIVEDKadziela 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.
PMID: 23913461DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacek Kadziela, MD,PhD
National Institute of Cardiology, Warsaw, Poland
- PRINCIPAL INVESTIGATOR
Adam Witkowski, Prof
National Institute of Cardiology, Warsaw, Poland
- PRINCIPAL INVESTIGATOR
Andrzej Januszewicz, Prof
National Institute of Cardiology, Warsaw, Poland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 21, 2010
First Posted
May 24, 2010
Study Start
June 1, 2006
Primary Completion
December 1, 2009
Study Completion
May 1, 2010
Last Updated
May 24, 2010
Record last verified: 2010-05