Text Size

Renal Fractional Flow Reserve in Renal Artery Stenting (PREFFER)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by:
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01128933
First received: May 21, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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


Condition Intervention
Renal Artery Stenosis
Hypertension
 Procedure: Renal artery stenting

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • Blood pressure improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Kidney function preservation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: June 2006
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypertensive patients
Hypertensive patients with at least moderate renal artery stenosis
 Procedure: Renal artery stenting

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128933

Locations
Poland
Institute of Cardiology
Warsaw, Poland, 04-628
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
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
  More Information

Additional Information:
Web page of Institute of Cardiology, Warsaw  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jacek Kadziela, Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT01128933     History of Changes
Other Study ID Numbers: 2P05B02530
Study First Received: May 21, 2010
Last Updated: May 21, 2010
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Institute of Cardiology, Warsaw, Poland:
Fractional flow reserve
Revascularization
Prognosis
Hemodynamics
Hypertension

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

ClinicalTrials.gov processed this record on May 16, 2013