Systolic Blood Pressure Intervention Trial: Memory and Cognition in Decreased Hypertension (SPRINT-MIND)
Systolic Blood Pressure Intervention Trial: Memory and Cognition in Decreased Hypertension (SPRINT-MIND)
Overall Status:
Recruiting
Brief Description:
The Systolic Blood Pressure Intervention Trial (SPRINT) is testing whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended will reduce cardiovascular disease risk. A subset of SPRINT is SPRINT-MIND, which seeks to determine the effects of reducing SBP on cognitive function. The primary hypothesis of SPRINT-MIND is that over an average of 60 months, the incidence of all-cause dementia will be lower in SPRINT participants assigned to the intensive SBP treatment arm compared to their counterparts assigned to the standard SBP treatment arm. This hypothesis will be tested in all SPRINT participants. In addition, 2,800 SPRINT participants will be tested, over an average of 48 months, to determine if the rate of global decline in cognition measured across key domains of cognition will be lower in the intensive SBP treatment arm compared to the standard SBP treatment arm.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | N/A | Both | Accepts Healthy Volunteers |
Inclusion Criteria:
- Age 50 or older
- High blood pressure with the systolic (upper) number at least 130 mm Hg
- One or more of the following risk factors: Age greater than 75 years, presence of cardiovascular disease other than stroke, chronic kidney disease, Framingham Risk Score for 10-year cardiovascular disease risk of 15 percent or more
Exclusion Criteria:
- Clinical diagnosis of dementia, treatment with medications for dementia, or cognitively unable to follow the protocol
- Presence of a condition normally requiring a specific blood pressure-lowering medication (such as a beta-blocker following acute myocardial infarction), but the individual is not taking that medication and has not been documented to be intolerant of the medication class
- Known secondary cause of hypertension that causes concern regarding safety
- One-minute standing systolic blood pressure less than 110 mm Hg
- Proteinuria (excessive amounts of protein in urine)
- Arm circumference too large or small to allow accurate blood pressure measurement with available devices
- Diabetes mellitus, history of stroke, or diagnosis of polycystic kidney disease
- Estimated glomerular filtration rate less than 20 ml/min /1.73m2 or end-stage renal disease
- Cardiovascular event or procedure or hospitalization for unstable angina within last 3 months
- Symptomatic heart failure within the past 6 months or left ventricular ejection fraction (by any method) of less than 35%
- Medical condition likely to limit survival to less than 3 years or malignancy other than nonmelanoma skin cancer within the last 2 years
- Currently participating in another clinical trial (intervention study). Note: Patient must wait until the completion of his/her activities or the completion of the other trial before being screened for SPRINT
- Living in the same household as a SPRINT participant
- Any organ transplant
- Unintentional weight loss greater than 10% in last 6 months
- Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control
- Prohibited medications: Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy
Detailed Description:
Elevated blood pressure (BP) is an important public health concern. The already high prevalence of elevated BP may be increasing, and it is a risk factor for several adverse health outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline in cognitive function. The Systolic Blood Pressure Intervention Trial (SPRINT) is a two-arm, multicenter, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended will reduce cardiovascular disease risk. A subset of SPRINT is SPRINT-MIND, which seeks to determine the effects of reducing SBP on cognitive function.
The primary hypothesis of SPRINT-MIND is that over an average of 60 months, the incidence of all-cause dementia will be lower in SPRINT participants assigned to the intensive SBP treatment arm compared to their counterparts assigned to the standard SBP treatment arm. This hypothesis will be tested in all SPRINT participants.
A total of 2800 SPRINT participants will also be tested, over an average of 48 months, to determine if the rate of global decline in cognition measured across key domains of cognition will be lower in the intensive SBP treatment arm compared to the standard SBP treatment arm.
Approximately 640 participants will be chosen from the subset of 2800 SPRINT participants for an MRI sub-study to determine whether, over an average of 48 months, the volume small vessel ischemic disease will be lower in SPRINT participants assigned to the intensive SBP treatment arm compared to their counterparts assigned to the standard SBP treatment arm. An additional hypothesis is that total brain volume will also be greater (thus less atrophy) in the intensively treated group.
SPRINT participants will be recruited at approximately 90 clinics within five clinical center networks over a 2-year period and will be followed for 4-6 years. SPRINT-MIND participants must be enrolled in SPRINT. Participants will be randomized to one of two goals: SBP less than 120 mm Hg for the Intensive Group and SBP less than 140 mm Hg for the Standard Group. Use of once-daily preparations of antihypertensive agents will be encouraged unless alternative dosing frequency (for example, twice daily) is necessary. One or more medications will be provided by the study and intended for use in managing participants in both randomization groups to achieve study goals.
Central Contact Information:
To find contact information for the site nearest you, please go to SPRINT Find a Site and enter your zip code. You may also contact any of the following study coordinators:
- Carolyn Harmon Still, 216-844-3798, carolyn.still@uhhospitals.org
- John Summerson, 336-716-2125, jsummers@wakehealth.edu
- Lisa Gren, 801-585-6232, lisa.gren@hsc.utah.edu
- Kim Jenkins, 205-934-0075, kimjenkins@uabmc.edu
- Sandy Walsh, 901-523-8990 ext. 6598, sandy.walsh@va.gov
Locations:
| Map Marker | City | State | Zip Code | |
|---|---|---|---|---|
Geolocation is 34.761354, -87.0824045 | Athens Internal Medicine | Athens | Alabama | 35611 |
Geolocation is 33.5075555, -86.8093239 | UAB Chronic Kidney Disease Clinic | Birmingham | Alabama | 35294 |
Geolocation is 33.449373, -86.8671989 | UAB Vascular Biology and Hypertension Clinic | Birmingham | Alabma | 35211 |
Geolocation is 33.449373, -86.8671989 | Nephrology Associates | Birmingham | Alabama | 35211 |
Geolocation is 33.5114334, -112.0685027 | Phoenix VA Health Care System | Phoenix | Arizona | 85012 |
Geolocation is 34.7486563, -92.3542193 | John L. McClellan Memorial VA Hospital | Little Rock | Arkansas | 72205 |
Geolocation is 34.0522561, -118.452087 | VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 |
Geolocation is 34.041208534, -118.442596 | University of California Los Angeles | Los Angeles | California | 90025 |
Geolocation is 48.560407048, 38.648718413 | Stanford University | Palo Alto | California | 94034 |
Geolocation is 38.5500434, -121.4599012 | University of California Davis Medical Center | Sacramento | California | 95817 |
Geolocation is 32.8758428, -117.2367464 | University of California San Diego | San Diego | California | 92161 |
Geolocation is 39.9389199, -105.0674317 | University of Colorado | Denver | Colorado | 80020 |
Geolocation is 38.9042365, -77.0521289 | George Washington University Division of Renal Diseases and Hypertension | Washington | District of Columbia | 20037 |
Geolocation is 38.9246554, -77.0111048 | Washington DC VA Medical Center | Washington | District of Columbia | 20422 |
Geolocation is 29.6156734, -82.3659168 | Malcolm Randall VA Medical Center | Gainesville | Florida | 32608 |
Geolocation is 29.6156734, -82.3659168 | University of Florida | Gainesville | Florida | 32608 |
Geolocation is 30.2606613, -81.460856 | Mayo Clinic | Jacksonville | Florida | 32224 |
Geolocation is 25.7862401, -80.2349196 | University of Miami Veterans Affairs | Miami | Florida | 33125 |
Geolocation is 25.7870967, -80.2042436 | University of Miami | Miami | Florida | 33136 |
Geolocation is 28.0563834, -82.4427769 | University of South Florida | Tampa | Florida | 33612 |
Geolocation is 33.7980995, -84.3259367 | Emory University | Atlanta | Georgia | 30322 |
Geolocation is 33.7321902, -84.4225186 | Morehouse School of Medicine | Atlanta | Georgia | 30310 |
Geolocation is 33.8092255, -84.2805478 | Atlanta VA Medical Center | Atlanta | Georgia | 30033 |
Geolocation is 33.474324, -81.9899547 | Georgia Health Sciences University (MCG) | Augusta | Georgia | 30912 |
Geolocation is 41.8816606, -87.6926257 | University of Illinois Section of Nephrology | Chicago | Illinois | 60612 |
Geolocation is 41.8745965, -87.8402405 | Loyola University Medical Center | Maywood | Illinois | 60153 |
Geolocation is 30.4192451, -91.1448981 | Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 |
Geolocation is 30.448255, -91.1209121 | Baton Rouge General Hospital | Baton Rouge | Louisiana | 70806 |
Geolocation is 35.0180661, 24.9754175 | Tulane University | New Orleans | Louisiana | 70012 |
Geolocation is 29.9595068, -90.1565209 | Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 |
Geolocation is 42.3514653, -71.0601767 | Tufts NE Medical Center | Boston | Massachusetts | 02111 |
Geolocation is 42.3097365, -71.1151431 | Boston VA Medical Center | Jamaica Plain | Massachusetts | 02130 |
Geolocation is 42.2717443, -71.7588217 | University of Massachusetts | Worcester | Massachusetts | 01655 |
Geolocation is 42.3053253, -83.6694169 | University of Michigan Geriatrics Center | Ann Arbor | Michigan | 48109 |
Geolocation is 42.3664506, -83.0737195 | Henry Ford Hospital | Detroit | Michigan | 48202 |
Geolocation is 42.348495, -83.0602998 | John D. Dingell VA Medical Center | Detroit | Michigan | 48201 |
Geolocation is 44.903044, -93.2332244 | Minneapolis VA Medical Center | Minneapolis | Minnesota | 55417 |
Geolocation is 32.3361632, -90.1565209 | GV (Sonny) Montgomery VA Medical Center | Jackson | Mississippi | 39216 |
Geolocation is 32.3361632, -90.1565209 | University of Mississippi Medical Center | Jackson | Mississippi | 39216 |
Geolocation is 39.0611649, -94.5366582 | Kansas City VA Medical Center | Kansas City | Missouri | 64128 |
Geolocation is 38.6449348, -90.2080547 | St Louis VA Medical Center | St. Louis | Missouri | 63106 |
Geolocation is 40.7564795, -74.2208673 | VA NJ Health Care System | East Orange | New Jersey | 07018 |
Geolocation is 40.48621574, -74.4518188 | University of Medicine and Dentistry of New Jersey (UMDNJ) | New Brunswick | New Jersey | 08901 |
Geolocation is 35.0734065, -106.5760857 | Albuquerque VA Medical Center | Albuquerque | New Mexico | 87108 |
Geolocation is 40.8687887, -73.8977693 | Bronx VA Medical Center | Bronx | New York | 10468 |
Geolocation is 40.6515882, -73.9330429 | SUNY Downstate Medical College | Brooklyn | New York | 11203 |
Geolocation is 40.8409822, -73.9447994 | Irving Pavilion Research Unit Columbia University | New York | New York | 10032 |
Geolocation is 40.8557765, -73.9447994 | Washington Heights Family Health Center | New York | New York | 10033 |
Geolocation is 51.1464753, 27.5694468 | Clinical Cardiovascular Research Lab for the Elderly Columbia University | New York | New York | 11034 |
Geolocation is 40.7388319, -73.9815337 | New York Harbor VAMC | New York | New York | 10010 |
Geolocation is 40.9075916, -73.3354993 | Northpoint VA Medical Center | Northpoint | New York | 11768 |
Geolocation is 42.3200938, -79.5715822 | Great Lakes Medical Research | Westfield | New York | 14787 |
Geolocation is 35.1928527, -80.823938 | Carolinas Medical Center | Charlotte | North Carolina | 28207 |
Geolocation is 36.0038131, -78.9387241 | Duke University | Durham | North Carolina | 27710 |
Geolocation is 35.6450428, -77.4242972 | East Carolina University | Greenville | North Carolina | 27834 |
Geolocation is 35.4320083, -77.5504779 | Robeson Health Care Corp | Lumberton | North Carolina | 28538 |
Geolocation is 36.0906568, -80.2715385 | WFUHS Department of Nephrology | Winston-Salem | North Carolina | 27157 |
Geolocation is 36.0104644, -80.1651854 | WFUHS Downtown Health Plaza | Winston-Salem | North Carolina | 27107 |
Geolocation is 36.0906568, -80.2715385 | WFUHS Department of Geriatrics | Winston-Salem | North Carolina | 27157 |
Geolocation is 41.3788177, -81.5267282 | UH Bedford Medical Center | Bedford | Ohio | 44146 |
Geolocation is 41.5091257, -81.6089873 | UH Otis Moss Medical Center | Cleveland | Ohio | 44106 |
Geolocation is 41.5034433, -81.6205953 | Cleveland Clinic Foundation Dept of Nephrology and Hypertension | Cleveland | Ohio | 44195 |
Geolocation is 41.5091257, -81.6089873 | Louis Stokes VA Medical Center | Cleveland | Ohio | 44106 |
Geolocation is 41.4513221, -81.7021049 | Metro Health Med Center | Cleveland | Ohio | 44109 |
Geolocation is 41.5214566, -81.6418656 | Northeast Ohio Neighborhood Medical Center | Cleveland | Ohio | 44103 |
Geolocation is 41.5091257, -81.6089873 | University Hospitals (UH) Case Med Center | Cleveland | Ohio | 44106 |
Geolocation is 39.9990626, -83.0173386 | Ohio State University Medical Center (OSU) Division of Nephrology and Hypertension | Columbus | Ohio | 43210 |
Geolocation is 39.9705946, -82.9689738 | OSU Medical Center Division of Endocrinology, Diabetes and Metabolism | Columbus | Ohio | 43203 |
Geolocation is 39.7446945, -84.2565237 | Dayton VA Medical Center | Dayton | Ohio | 45428 |
Geolocation is 41.4932198, -81.460856 | UH Landerbrook Health Center | Mayfield Heights | Ohio | 44124 |
Geolocation is 41.3258767, -81.7568253 | UH Glenridge Office Park | North Royalton | Ohio | 44133 |
Geolocation is 41.5233346, -81.5322149 | UH Suburban Health Center | South Euclid | Ohio | 44121 |
Geolocation is 45.4874111, -122.6875541 | Portland VA Medical Center | Portland | Oregon | 97239 |
Geolocation is 40.012545, -75.1487007 | Temple University | Philadelphia | Pennsylvania | 19140 |
Geolocation is 39.9583587, -75.1953934 | University of Pennsylvania Renal Center | Philadelphia | Pennsylvania | 19104 |
Geolocation is 40.4379259, -79.9556424 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 |
Geolocation is 18.294378, -66.0344581 | Centro Cardiovascular de Caguas | El Verde | Puerto Rico | 00725 |
Geolocation is 18.294378, -66.0344581 | Family Care Practice | Fajardo | Puerto Rico | 00725 |
Geolocation is 18.3419118, -66.058249 | Private Practice | San Juan | Puerto Rico | 00926 |
Geolocation is 60.220083718, 25.0658787 | Altamira Family Practice and Research | San Juan | Puerto RIco | 00920 |
Geolocation is 60.220083718, 25.0658787 | Centro Clinico San Patricio | San Juan | Puerto Rico | 00920 |
Geolocation is 32.785895, -79.9479496 | Medical University of South Carolina Nephrology | Charleston | South Carolina | 29425 |
Geolocation is 32.7791432, -79.9248669 | Ralph H. Johnson Charleston VA Medical Center | Charleston | South Carolnia | 29401 |
Geolocation is 34.1156043, -81.0533854 | University of South Carolina | Columbia | South Carolina | 29203 |
Geolocation is 35.1516237, -90.0349866 | University of Tennessee Health Sciences | Memphis | Tennessee | 38105 |
Geolocation is 35.1323787, -90.004663 | Memphis VA Medical Center | Memphis | Tennessee | 38104 |
Geolocation is 36.1390165, -86.7969244 | VA Tennessee Valley Health Care System | Nashville | Tennessee | 37212 |
Geolocation is 36.1426398, -86.8001068 | Vanderbilt University Medical Center | Nashville | Tennessee | 37232 |
Geolocation is 36.1030036, -86.8722146 | West End Medical Group St Thomas Hospital | Nashville | Tennessee | 37205 |
Geolocation is 36.1523805, -86.7893889 | Nashville Medical Group Baptist Hospital | Nashville | Tennessee | 37203 |
Geolocation is 32.9678449, -96.8887202 | Punzi Medical Center and Trinity Hypertension Research | Carrollton | Texas | 75006 |
Geolocation is 32.8113367, -96.8397899 | University of Texas SW Division of Nephrology | Dallas | Texas | 75390 |
Geolocation is 29.7050857, -95.4018087 | Houston VA Medical Center | Houston | Texas | 77030 |
Geolocation is 29.5238191, -98.5927074 | San Antonio VAMC | San Antonio | Texas | 78284 |
Geolocation is 0, 0 | Intermountain Healthcare | Murray | Utah | |
Geolocation is 40.7652201, -111.8419536 | University of Utah Division of Nephrology | Salt Lake City | Utah | 84112 |
Geolocation is 40.7652201, -111.8419536 | Salt Lake City VA Division of Nephrology | Salt Lake City | Utah | 84112 |
Geolocation is 43.0223032, -87.9763543 | Clement J Zablocki VA Medical Center | Milwaukee | Wisconsin | 53295 |
Lead Sponsor:
| Agency |
|---|
National Heart, Lung, and Blood Institute (NHLBI) |
Collaborator Sponsor:
| Agency |
|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
National Institute of Neurological Disorders and Stroke (NINDS) |
National Institute on Aging (NIA) |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
David M. Reboussin, PhD | Principal Investigator | National Heart, Lung, and Blood Institute |
Jackson T. Wright, MD | Principal Investigator | Case Western Reserve University |
Alfred Cheung, MD | Principal Investigator | University of Utah |
Suzanne Oparil, MD | Principal Investigator | University of Alabama at Birmingham |
Mike Rocco, MD | Principal Investigator | Wake Forest University |
Bill Cushman, MD | Principal Investigator | Memphis VA Medical Center |
Study Contact:
Locations
ClinicalTrials.gov ID
NCT01206062 (follow link to view full record on ct.gov in new window)
Official Title:
Systolic Blood Pressure Intervention Trial, Memory and Cognition in Decreased Hypertension
Study Start Date:
October 2010
Study End Date:
December 2018
Disease Stage:
Pre-clinical
Enrollment:
2800
