Renal Fractional Flow Reserve in Renal Artery Stenting

NCT ID: NCT01128933

Last Updated: 2010-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-05-31

Brief Summary

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

Detailed Description

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Conditions

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Renal Artery Stenosis Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypertensive patients

Hypertensive patients with at least moderate renal artery stenosis

Group Type EXPERIMENTAL

Renal artery stenting

Intervention Type PROCEDURE

Interventions

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Renal artery stenting

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Higher Education, Poland

OTHER_GOV

Sponsor Role collaborator

National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role lead

Responsible Party

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Institute of Cardiology, Warsaw, Poland

Principal Investigators

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Jacek Kadziela, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiology, Warsaw, Poland

Adam Witkowski, Prof

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiology, Warsaw, Poland

Andrzej Januszewicz, Prof

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiology, Warsaw, Poland

Locations

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Institute of Cardiology

Warsaw, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type DERIVED
PMID: 25268986 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23913461 (View on PubMed)

Related Links

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http://www.ikard.pl

Web page of Institute of Cardiology, Warsaw

Other Identifiers

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2P05B02530

Identifier Type: -

Identifier Source: org_study_id

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