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

• ClinicalTrials.gov Identifier: NCT01475747
• Recruitment Status: Completed
• First Posted: November 21, 2011
• Last Update Posted: January 4, 2019
• Sponsor: University of Utah
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Srinvasan Beddhu, University of Utah

Tracking Information

• First Submitted Date: November 16, 2011
• First Posted Date: November 21, 2011
• Last Update Posted Date: January 4, 2019
• Study Start Date: September 2011
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 9, 2016)

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.

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Systolic Pressure Intervention Trial Factors Affecting Factors Affecting Atherosclerosis Study
• Official Title: Systolic Pressure Intervention Trial (SPRINT)-Factors Affecting Factors Affecting Atherosclerosis Study (FAST)

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Urine, plasma and serum samples.

• 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.

Condition

• Hypertension
• Chronic Kidney Disease

• Intervention: Not Provided

Study Groups/Cohorts

Observational - SPRINT trial subjects

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 10, 2018): 595
• Original Estimated Enrollment (submitted: November 18, 2011): 600
• Actual Study Completion Date: December 2018
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Eligibility 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.)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01475747
• Other Study ID Numbers: IRB_00049314; R01DK091437-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Srinvasan Beddhu, University of Utah
• Original Responsible Party: University of Utah
• Current Study Sponsor: University of Utah
• Original Study Sponsor: Same as current
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Srinivasan Beddhu, MD; University of Utah

• PRS Account: University of Utah
• Verification Date: January 2019