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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by University of Utah
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah
ClinicalTrials.gov Identifier:
NCT01475747
First received: November 16, 2011
Last updated: August 9, 2016
Last verified: August 2016

November 16, 2011
August 9, 2016
September 2011
December 2016   (final data collection date for primary outcome measure)
Development Rate of Atherosclerosis [ Time Frame: Baseline and 30 months ] [ Designated as safety issue: No ]
Correlation of the presence of CKD and rate of progression of atherosclerosis as assessed by magnetic resonance imaging (MRI) of the carotid artery.
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Complete list of historical versions of study NCT01475747 on ClinicalTrials.gov Archive Site
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Systolic Pressure Intervention Trial Factors Affecting Factors Affecting Atherosclerosis Study
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
Urine, plasma and serum samples.
Non-Probability Sample
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.
  • Hypertension
  • Chronic Kidney Disease
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
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December 2016   (final data collection date for primary outcome measure)

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.)
Both
50 Years and older   (Adult, Senior)
No
Contact: Rebecca M Filipowicz, MS 801-587-5868 rebecca.filipowicz@hsc.utah.edu
Contact: Srinivasan Beddhu, MD srinivasan.beddhu@hsc.utah.edu
United States
 
NCT01475747
IRB_00049314, R01DK091437-01
Yes
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Srinvasan Beddhu, University of Utah
University of Utah
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Srinivasan Beddhu, MD University of Utah
University of Utah
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP