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NCT01128933 Clinical Trial

Renal Fractional Flow Reserve in Renal Artery Stenting

Hypertension Clinical Trial

— PREFFER  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01128933
Other study ID # 2P05B02530
Secondary ID
Status Completed
Phase N/A
First received May 21, 2010
Last updated May 21, 2010
Start date June 2006
Est. completion date May 2010

Study information
Verified date May 2010
Source Institute of Cardiology, Warsaw, Poland
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Science and Higher Education
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date May 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Renal artery stenting

Locations
Country Name City State
Poland Institute of Cardiology Warsaw

Sponsors (2)
Lead Sponsor Collaborator
Institute of Cardiology, Warsaw, Poland Ministry of Science and Higher Education, Poland

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood pressure improvement 6 months No
Secondary Kidney function preservation 6 months No
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