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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Utah
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah
ClinicalTrials.gov Identifier:
NCT01475747
First received: November 16, 2011
Last updated: December 9, 2013
Last verified: December 2013

November 16, 2011
December 9, 2013
September 2011
September 2015   (final data collection date for primary outcome measure)
CKD and Atherosclerosis [ Time Frame: Baseline and 30 months ] [ Designated as safety issue: No ]

To examine

  1. Whether the presence of CKD is indeed associated with faster rate of progression of atherosclerosis as assessed by magnetic resonance imaging (MRI) of the carotid artery.
  2. Whether there is a effect modification of the associations of blood pressure treatment groups with atherosclerosis progression by the presence or absence of CKD.
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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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*   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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September 2015   (final data collection date for primary outcome measure)

All potential SPRINT participants at the SPRINT-FAST sites will be screened for eligibility to participate in SPRINT-FAST. The only medical exclusion criterion for SPRINT-FAST is contraindications to MRI (such as intracranial metal prostheses and claustrophobia). If there is no contraindication, the potential SPRINT participant will be asked whether they would also participate in SPRINT-FAST. Additional study procedures (MRI, blood and urine samples) of SPRINT-FAST will be explained. If the potential SPRINT participant consents for SPRINT-FAST, upon meeting the inclusion and exclusion criteria for the parent study, they will be scheduled for MRI.

Patients who cannot undergo MRI (weight > 300 lbs, certain types of hardware used in pacemakers, prostheses etc).

Both
50 Years and older
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
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
December 2013

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