Systolic Pressure Intervention Trial Factors Affecting Factors Affecting Atherosclerosis Study

NCT ID: NCT01475747

Last Updated: 2019-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

595 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Chronic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational - SPRINT trial subjects

Subjects in the Systolic Pressure Intervention Trial (SPRINT) observed to examine factors that affect atherosclerosis in chronic kidney disease

No interventions assigned to this group

Eligibility Criteria

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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.)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Srinvasan Beddhu

MD, Assiociate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Srinivasan Beddhu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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Stanford University

Palo Alto, California, United States

Site Status

University of Colorado Denver

Denver, Colorado, United States

Site Status

George Washington University

Washington D.C., District of Columbia, United States

Site Status

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

University of Pennsylvania

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsburg

Pittsburgh, Pennsylvania, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Beddhu S, Boucher RE, Sun J, Balu N, Chonchol M, Navaneethan S, Chertow GM, Townsend R, Haley W, Cheung AK, Conroy MB, Raj DS, Xu D, George T, Yunis R, Wei G, Canton G, Bates J, Chen J, Papademetriou V, Punzi H, Wiggers A, Wright JT, Greene T, Yuan C. Chronic kidney disease, atherosclerotic plaque characteristics on carotid magnetic resonance imaging, and cardiovascular outcomes. BMC Nephrol. 2021 Feb 24;22(1):69. doi: 10.1186/s12882-021-02260-x.

Reference Type DERIVED
PMID: 33627066 (View on PubMed)

Other Identifiers

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R01DK091437-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB_00049314

Identifier Type: -

Identifier Source: org_study_id

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