N/A
N=9,361
Systolic Blood Pressure Intervention Trial
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01206062 ↗Enrolled (actual)
9,361
Serious AEs
37.7%
Results posted
Dec 2017
Primary outcome: Primary: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death — 243; 319 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intensive control of SBP (Drug); Standard control of SBP (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death |
243; 319 | <0.001 sig |
| SECONDARY Number of Participants With All-cause Mortality |
155; 210 | 0.003 sig |
| SECONDARY Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR |
10; 12 | 0.58 |
| SECONDARY Participants Who Developed End Stage Renal Disease |
12; 8 | — |
| SECONDARY Number of Patients With All-cause Dementia |
149; 176 | .10 |
| SECONDARY Small Vessel Cerebral Ischemic Disease |
0.23; 0.37; -7.7; -6.8 | — |
Summary
Elevated blood pressure (BP) is an important public health concern. It is highly prevalent, the prevalence 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 2-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 (CVD) risk.
Eligibility Criteria
Inclusion Criteria
- At least 50 years old
Systolic blood pressure of
- 130 - 180 mm Hg on 0 or 1 medication
- 130 - 170 mm Hg on up to 2 medications
- 130 - 160 mm Hg on up to 3 medications
- 130 - 150 mm Hg on up to 4 medications
Risk (one or more of the following)
- Presence of clinical or subclinical cardiovascular disease other than stroke
- CKD, defined as eGFR 20 - 59 ml/min/1.73m2
- A Framingham Risk Score for 10-year CVD risk ≥ 15%
- Age greater than 75 years
Exclusion Criteria
- An indication for a specific BP lowering medication that the person is not taking and the person has not been documented to be intolerant of the medication class.
- Known secondary cause of hypertension that causes concern regarding safety of the protocol.
- One minute standing SBP 10% in last 6 months
- Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control.
Data sourced from ClinicalTrials.gov (NCT01206062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.