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NCT01475747 Clinical Trial

Systolic Pressure Intervention Trial Factors Affecting Factors Affecting Atherosclerosis Study

Hypertension Clinical Trial

— SPRINTFAST  

Official title:
Systolic Pressure Intervention Trial (SPRINT)-Factors Affecting Factors Affecting Atherosclerosis Study (FAST)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01475747
Other study ID # IRB_00049314
Secondary ID R01DK091437-01
Status Completed
Phase
First received
Last updated
Start date September 2011
Est. completion date December 2018

Study information
Verified date January 2019
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Systolic Pressure Intervention Trial (SPRINT) is a large scale randomized trial of ~ 9250 adults aged 50 years or older with high cardiovascular risk sponsored by NIH. The study is designed to recruit 45% of the study population with Chronic Kidney Disease (CKD). The trial will test the effects of low systolic blood pressure (SBP) goal of < 120 mm Hg versus the standard goal of < 140 mm Hg on the primary composite of cardiovascular events and death. One of the pre-specified secondary outcome is the progression of kidney disease. In this ancillary named SPRINT - Factors affecting Atherosclerosis STudy (FAST), the investigators plan to take advantage of the unique opportunities afforded by the parent study to examine issues that are of significant public health importance.

This is an observational study in SPRINT participants. This study will examine mechanistically, the factors affecting the progression of atherosclerosis in CKD.

Recruitment information / eligibility
Status Completed
Enrollment 595
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria

- Systolic Pressure Intervention Trial (SPRINT) participants

Exclusion Criteria

- Contraindications to MRI (such as intracranial metal prostheses, weight > 300 pounds, claustrophobia and certain types of hardware used in pacemakers, prostheses, etc.)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cleveland Ohio
United States University of Colorado Denver Denver Colorado
United States Mayo Clinic Jacksonville Jacksonville Florida
United States University of Minnesota Minneapolis Minnesota
United States Stanford University Palo Alto California
United States University of Pennsylvania Pittsburgh Pennsylvania
United States University of Pittsburg Pittsburgh Pennsylvania
United States University of Utah Salt Lake City Utah
United States University of Washington Seattle Washington
United States George Washington University Washington District of Columbia
United States Wake Forest University Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
University of Utah National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development Rate of Atherosclerosis Correlation of the presence of CKD and rate of progression of atherosclerosis as assessed by magnetic resonance imaging (MRI) of the carotid artery. Baseline and 30 months
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