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Systolic Pressure Intervention Trial Factors Affecting Factors Affecting Atherosclerosis Study (SPRINTFAST)

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ClinicalTrials.gov Identifier: NCT01475747
Recruitment Status : Active, not recruiting
First Posted : November 21, 2011
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah

Brief 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.


Condition or disease
Hypertension Chronic Kidney Disease

Study Type : Observational
Actual Enrollment : 595 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Systolic Pressure Intervention Trial (SPRINT)-Factors Affecting Factors Affecting Atherosclerosis Study (FAST)
Study Start Date : September 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Observational - SPRINT trial subjects
Subjects in the Systolic Pressure Intervention Trial (SPRINT) observed to examine factors that affect atherosclerosis in chronic kidney disease



Primary Outcome Measures :
  1. Development Rate of Atherosclerosis [ Time Frame: Baseline and 30 months ]
    Correlation of the presence of CKD and rate of progression of atherosclerosis as assessed by magnetic resonance imaging (MRI) of the carotid artery.


Biospecimen Retention:   Samples Without DNA
Urine, plasma and serum samples.


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinical characteristics of the SPRINT-FAST population will reflect those of the parent study. In this ancillary study, one non-CKD participant (control) will be recruited for each CKD participant (case). SPRINT CKD stratum will likely comprise of those with eGFR between 20-59 ml/min/1.73 m2.
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475747


Locations
United States, California
Stanford University
Palo Alto, California, United States, 94340
United States, Colorado
University of Colorado Denver
Denver, Colorado, United States, 80045
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20052
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27109
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburg
Pittsburgh, Pennsylvania, United States, 15260
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84103
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Utah
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Srinivasan Beddhu, MD University of Utah

Responsible Party: Srinvasan Beddhu, MD, Assiociate Professor of Medicine, University of Utah
ClinicalTrials.gov Identifier: NCT01475747     History of Changes
Other Study ID Numbers: IRB_00049314
R01DK091437-01 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2011    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Atherosclerosis
Urologic Diseases
Renal Insufficiency
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases