Systolic Blood Pressure Intervention Trial(SPRINT)

Study ID
STU 092010-213

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Tammy Lightfoot
214-645-8265
tammy.lightfoot@utsouthwestern.edu

Principal Investigator
Robert Toto

Summary

This is an niH sponsored multicenter randomized controlled clinical trial that will last 4-8 yrs with up to 100 sites for 10,000 subjects. FDa approved blood pressure (BP) drugs will be used to control subjects[Greater Than]/[?] 50yrs old randomized to 2 BP groups (intensive/ standard). Health questionnaires, blood and urine test, dementia testing and Dna samples will be collected. Subjects will be seen for screening, randomization, every month for 3 months and then every 3 months for the duration of the study. unscheduled visits will be held for uncontrolled blood pressure, abnormal labs, aes and Sae follow-ups.

Participant Eligibility

1) At least 50 years old
2) Systolic blood pressure
a) SBP: 130 x 180 mm Hg on 0 or 1 medication
b) SBP: 130 x 170 mm Hg on up to 2 medications
c) SBP: 130 x 160 mm Hg on up to 3 medications
d) SBP: 130 x 150 mm Hg on up to 4 medications

3) There are no diastolic blood pressure (DBP) inclusion criteria, since risk is more related to SBP than DBP in the age and risk population anticipated for SPRINT. If a screenee is otherwise eligible for SPRINT but presents with a treated BP and/or number of medications that fall outside the SPRINT inclusion criteria, BP-lowering medications may be adjusted prior to the randomization visit to determine whether, with such adjustments, the screenee will meet eligibility criteria for SPRINT. A screenee who presents on no BP medications should have documentation of SBP >=130 mm Hg on 2 visits within 3 months prior to the randomization visit in order to be eligible for the trial.
4) Risk (one or more of the following)
a) Presence of clinical* or subclinical** cardiovascular disease other than stroke
b) CKD, defined as eGFR 20 x 59 ml/min/1.73m2 based on the 4-variable Modification of Diet in Renal Disease (MDRD) equation and latest lab value, within the past 6 months. (If the serum creatinine is unstable within the last 6 months, enrollment into SPRINT could be delayed until the serum creatinine has been stabilized and the eGFR is still within the allowed range.)
c) A Framingham Risk Score for 10-year CVD risk >= 15% based on laboratory work done within the past 12 months for lipids (See Appendix 2).

5) Clinical CVD (other than stroke)
a) Previous myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), carotid endarterectomy (CE), carotid stenting
b) Peripheral artery disease (PAD) with revascularization
c) Acute coronary syndrome with or without resting ECG change, ECG changes on a graded exercise test (GXT), or positive cardiac imaging study
d) At least a 50% diameter stenosis of a coronary, carotid, or lower extremity artery
e) Abdominal aortic aneurysm (AAA) >=5 cm with or without repair

6) Subclinical CVD
a) Coronary artery calcium score >= 400 Agatston units within the past 2 years.
b) Ankle brachial index (ABI) <=0.90 within the past 2 years.
c) Left ventricular hypertrophy (LVH) by ECG (based on computer reading), echocardiogram report, or other cardiac imaging procedure report within the past 2 years.

MIND THE KIDNEYS SUBSTUDY INCLUSION CRITERIA:

In MIND the Kidneys, CKD is defined on the basis of eGFR or the presence of albuminuria, defined as a spot urine albumin to creatinine ratio >=30 mg/g. For the purposes of determining eligibility for MIND the Kidneys, CKD status is defined on the basis of SPRINT randomization lab values.