Systolic Pressure Intervention Trial Factors Affecting Factors Affecting Atherosclerosis Study (SPRINTFAST)
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Purpose
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.
| Condition |
|---|
|
Hypertension Chronic Kidney Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Systolic Pressure Intervention Trial (SPRINT)-Factors Affecting Factors Affecting Atherosclerosis Study (FAST) |
- CKD and Atherosclerosis [ Time Frame: Baseline and 30 months ] [ Designated as safety issue: No ]
To examine
- 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.
- Whether there is a effect modification of the associations of blood pressure treatment groups with atherosclerosis progression by the presence or absence of CKD.
Biospecimen Retention: Samples Without DNA
Urine, plasma and serum samples.
| Estimated Enrollment: | 600 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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).
Contacts and Locations| Contact: Rebecca M Filipowicz, MS | 801-587-5868 | rebecca.filipowicz@hsc.utah.edu |
| Contact: Srinivasan Beddhu, MD | srinivasan.beddhu@hsc.utah.edu |
| United States, California | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94340 | |
| Contact: Jennifer Sabino jsabino@stanford.edu | |
| Contact: Glen Chertow, MD gchertow@standford.edu | |
| Sub-Investigator: Glen Chertow, MD | |
| United States, Colorado | |
| University of Colorado Denver | Recruiting |
| Denver, Colorado, United States, 80045 | |
| Contact: Michel Chonchol, MD | |
| Sub-Investigator: Michel Chonchol, MD | |
| United States, District of Columbia | |
| George Washington University | Active, not recruiting |
| Washington, District of Columbia, United States, 20052 | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Anthony Killeen, MD, PhD kille001@umn.edu | |
| Sub-Investigator: Anthony Killeen, MD, PhD | |
| United States, North Carolina | |
| Wake Forest University | Active, not recruiting |
| Winston, North Carolina, United States | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Navaneethan Sankar, MD NAVANES@ccfg.org | |
| Sub-Investigator: Navaneethan Sankar, MD | |
| Case Western Reserve University | Recruiting |
| Cleveland, Ohio, United States | |
| Contact: Jackson Wright, MD jxw20@case.edu | |
| Sub-Investigator: Jackson Wright, MD | |
| United States, Pennsylvania | |
| University of Pittsburg | Active, not recruiting |
| Pittsburg, Pennsylvania, United States | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84103 | |
| Contact: Rebecca Filipowicz, MS rebecca.filipowicz@hsc.utah.edu | |
| Contact: Srinivasan Beddhu, MD srinivasan.beddhu@hsc.utah.edu | |
| Principal Investigator: Srinivasan Beddhu, MD | |
| United States, Washington | |
| University of Washington | Active, not recruiting |
| Seattle, Washington, United States | |
| Principal Investigator: | Srinivasan Beddhu, MD | University of Utah |
More Information
No publications provided
| Responsible Party: | Srinvasan Beddhu, MD, Assiociate Professor of Medicine, University of Utah |
| ClinicalTrials.gov Identifier: | NCT01475747 History of Changes |
| Other Study ID Numbers: | IRB_00049314, R01DK091437-01 |
| Study First Received: | November 16, 2011 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Atherosclerosis Hypertension Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 23, 2013