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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Chronic Kidney Disease

• Study Type: Observational
• Enrollment (Actual): 595

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94340
      • Stanford University
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Denver
  • District of Columbia
    • Washington, District of Columbia, United States, 20052
      • George Washington University
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27109
      • Wake Forest University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburg
  • Utah
    • Salt Lake City, Utah, United States, 84103
      • University of Utah
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Srinivasan Beddhu, MD, University of Utah

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 21, 2011

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Atherosclerosis
• Other Study ID Numbers: IRB_00049314; R01DK091437-01 (U.S. NIH Grant/Contract)