Renal Fractional Flow Reserve in Renal Artery Stenting (PREFFER)

May 21, 2010 updated by: Institute of Cardiology, Warsaw, Poland

Prognostic Value of Renal Fractional Flow Reserve in Hypertensive Patients With Renal Artery Stenosis Qualified to Renal Artery Stenting

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 04-628
        • Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood pressure improvement
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Kidney function preservation
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cardiology, Warsaw, Poland

Collaborators

Ministry of Science and Higher Education, Poland

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 21, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (Estimate)

May 24, 2010

Study Record Updates

Last Update Posted (Estimate)

May 24, 2010

Last Update Submitted That Met QC Criteria

May 21, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2P05B02530

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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