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

This study is currently recruiting participants.
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
  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)

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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.


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
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475747

Contacts
Contact: Rebecca M Filipowicz, MS 801-587-5868 rebecca.filipowicz@hsc.utah.edu
Contact: Srinivasan Beddhu, MD srinivasan.beddhu@hsc.utah.edu

Locations
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, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States
Contact: Anna Harrell       Harrell.Anna@mayo.edu   
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
University of Pennsylvania Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Mark Duckworth, MD       markjd@mail.med.upenn.edu   
Principal Investigator: Ray Townsend, MD         
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
Sponsors and Collaborators
University of Utah
Investigators
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: December 9, 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 April 16, 2014