Alzheimer's Disease Education and Referral Center

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: 
No longer 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 AgeMax AgeGenderHealthy 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:

Locations: 
Map Marker CityStateZip 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: 
NameRoleAffiliation
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 
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