{ "release_id": "2b2017b84496b985", "id": "cardio:sprint", "owner": "cardio", "kind": "study", "slug": "sprint", "name": "Systolic Blood Pressure Intervention Trial (SPRINT)", "aliases": [ "SPRINT" ], "atlases": [ "cardio" ], "summary_plain": "A large US trial that compared aiming for a top blood-pressure number below 120 with aiming below 140 in adults aged 50 and over at higher heart risk who did not have diabetes or a past stroke.", "summary_technical": "NHLBI-sponsored, open-label randomized trial (NCT01206062) of 9361 adults comparing systolic targets below 120 and below 140 mm Hg. The composite cardiovascular primary outcome was adjudicated blind to assignment. The blood-pressure intervention was stopped early for benefit in 2015. Azilsartan and azilsartan with chlorthalidone were donated by Takeda and Arbor; the paper says neither company had any other role.", "editorial_state": "draft", "last_substantive_edit": "2026-10-09", "last_evidence_check": null, "next_review_due": null, "external_ids": [ { "namespace": "nct", "value": "NCT01206062" } ], "navigation": { "cardio": { "system": [ "blood-vessels" ], "condition-area": [ "hypertension" ] } }, "payload": { "design": "Randomized, parallel-group, open-label trial with blinded outcome adjudication at 102 clinical sites in 5 clinical-center networks in the United States including Puerto Rico. The registry records allocation as randomized and masking as single (outcomes assessor).", "drug_phase": "not_applicable", "registry_statuses": [ { "status": "COMPLETED", "snapshot": "cardio:ctgov-nct01206062-2026-10-09" } ], "start_date": { "date": "2010-10", "type": "actual", "snapshot": "cardio:ctgov-nct01206062-2026-10-09" }, "primary_completion_date": { "date": "2016-07", "type": "actual", "snapshot": "cardio:ctgov-nct01206062-2026-10-09" }, "completion_date": { "date": "2019-03", "type": "actual", "snapshot": "cardio:ctgov-nct01206062-2026-10-09" }, "countries": [ { "code": "US", "snapshot": "cardio:ctgov-nct01206062-2026-10-09" } ], "care_setting": { "description": "Outpatient trial clinics at 102 clinical sites in 5 clinical-center networks in the United States, including Puerto Rico. Nursing-home and assisted-living residents were not enrolled.", "snapshot": "cardio:pmc-pmc4689591-2026-10-09" }, "stopped_early": { "scope": "intervention", "date": "2015-08-20", "reason": "The NHLBI director accepted the data and safety monitoring board recommendation, made after analyses of the primary outcome crossed the monitoring boundary at two consecutive time points. The registry records the trial itself as completed.", "snapshot": "cardio:pmc-pmc4689591-2026-10-09" }, "enrollment": [ { "count": 9361, "basis": "randomized", "unit": "participants", "snapshot": "cardio:pubmed-26551272-2026-10-09" } ], "arms": [ { "id": "cardio:sprint-arm-intensive", "label": "Intensive treatment", "intervention": "cardio:intensive-sbp-lowering", "description": "Systolic target below 120 mm Hg, with medicines adjusted monthly toward the target. The registry says most participants started on two drugs and another drug was required at milepost visits if not at goal. Mean of 2.8 blood-pressure medicines over follow-up." }, { "id": "cardio:sprint-arm-standard", "label": "Standard treatment", "intervention": null, "description": "Systolic target below 140 mm Hg (abstract and registry). The paper says medicines were adjusted toward 135 to 139 mm Hg, with a dose reduction below 130 at one visit or below 135 at two consecutive visits. Mean of 1.8 medicines. Both arms used the same study formulary. No separate intervention entity is recorded for this comparator strategy." } ], "findings": [ { "id": "cardio:f-sprint-primary-intensive", "outcome_id": "cardio:outcome-sprint-primary-composite", "context_id": "cardio:ctx-sprint-adults-50plus-high-cv-risk-no-diabetes", "arm_id": "cardio:sprint-arm-intensive", "comparator_arm_id": null, "claim_id": "cardio:claim-sprint-primary-effect", "snapshot_id": "cardio:pmc-pmc4689591-2026-10-09", "endpoint_role": "primary", "effect_measure": "participants with at least one primary outcome event (count)", "numeric_value": 243, "reported_text": "243 (5.2%), 1.65% per year", "unit": "participants", "denominator": 4678, "denominator_status": null, "denominator_basis": "All participants randomized to the arm (Table 2 \"All participants\" N, intention to treat). The registry outcome denominator is the same.", "time_window": "Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "cardio:f-sprint-primary-standard", "outcome_id": "cardio:outcome-sprint-primary-composite", "context_id": "cardio:ctx-sprint-adults-50plus-high-cv-risk-no-diabetes", "arm_id": "cardio:sprint-arm-standard", "comparator_arm_id": null, "claim_id": "cardio:claim-sprint-primary-effect", "snapshot_id": "cardio:pmc-pmc4689591-2026-10-09", "endpoint_role": "primary", "effect_measure": "participants with at least one primary outcome event (count)", "numeric_value": 319, "reported_text": "319 (6.8%), 2.19% per year", "unit": "participants", "denominator": 4683, "denominator_status": null, "denominator_basis": "All participants randomized to the arm (Table 2 \"All participants\" N, intention to treat). The registry outcome denominator is the same.", "time_window": "Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "cardio:f-sprint-primary-hr", "outcome_id": "cardio:outcome-sprint-primary-composite", "context_id": "cardio:ctx-sprint-adults-50plus-high-cv-risk-no-diabetes", "arm_id": "cardio:sprint-arm-intensive", "comparator_arm_id": "cardio:sprint-arm-standard", "claim_id": "cardio:claim-sprint-primary-effect", "snapshot_id": "cardio:pubmed-26551272-2026-10-09", "endpoint_role": "primary", "effect_measure": "hazard ratio, intensive vs standard (Cox proportional-hazards, stratified by clinic, intention to treat)", "numeric_value": 0.75, "reported_text": "HR 0.75 (95% CI 0.64 to 0.89), P<0.001", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Comparison of the two per-arm rows (4678 vs 4683)", "time_window": "Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20", "estimate_lower": 0.64, "estimate_upper": 0.89, "interval_method": "two-sided 95% confidence interval", "interval_status": null }, { "id": "cardio:f-sprint-death-intensive", "outcome_id": "core:outcome-death-any-cause", "context_id": "cardio:ctx-sprint-adults-50plus-high-cv-risk-no-diabetes", "arm_id": "cardio:sprint-arm-intensive", "comparator_arm_id": null, "claim_id": "cardio:claim-sprint-mortality-effect", "snapshot_id": "cardio:pmc-pmc4689591-2026-10-09", "endpoint_role": "secondary", "effect_measure": "participants who died (count)", "numeric_value": 155, "reported_text": "155 (3.3%), 1.03% per year", "unit": "participants", "denominator": 4678, "denominator_status": null, "denominator_basis": "All participants randomized to the arm (Table 2 \"All participants\" N, intention to treat). The registry outcome denominator is the same.", "time_window": "Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "cardio:f-sprint-death-standard", "outcome_id": "core:outcome-death-any-cause", "context_id": "cardio:ctx-sprint-adults-50plus-high-cv-risk-no-diabetes", "arm_id": "cardio:sprint-arm-standard", "comparator_arm_id": null, "claim_id": "cardio:claim-sprint-mortality-effect", "snapshot_id": "cardio:pmc-pmc4689591-2026-10-09", "endpoint_role": "secondary", "effect_measure": "participants who died (count)", "numeric_value": 210, "reported_text": "210 (4.5%), 1.40% per year", "unit": "participants", "denominator": 4683, "denominator_status": null, "denominator_basis": "All participants randomized to the arm (Table 2 \"All participants\" N, intention to treat). The registry outcome denominator is the same.", "time_window": "Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "cardio:f-sprint-death-hr", "outcome_id": "core:outcome-death-any-cause", "context_id": "cardio:ctx-sprint-adults-50plus-high-cv-risk-no-diabetes", "arm_id": "cardio:sprint-arm-intensive", "comparator_arm_id": "cardio:sprint-arm-standard", "claim_id": "cardio:claim-sprint-mortality-effect", "snapshot_id": "cardio:pubmed-26551272-2026-10-09", "endpoint_role": "secondary", "effect_measure": "hazard ratio, intensive vs standard", "numeric_value": 0.73, "reported_text": "HR 0.73 (95% CI 0.60 to 0.90), P=0.003", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Comparison of the two per-arm rows (4678 vs 4683)", "time_window": "Median 3.26 years of follow-up, to the early stop of the blood-pressure intervention on 2015-08-20", "estimate_lower": 0.6, "estimate_upper": 0.9, "interval_method": "two-sided 95% confidence interval", "interval_status": null } ] }, "content_digest": "4327425bbaf725de122d6c16ee8c69ac89b169ec1ff707b798a2120b905d1142", "review": { "content_digest": "4327425bbaf725de122d6c16ee8c69ac89b169ec1ff707b798a2120b905d1142", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "2b2017b84496b985", "id": "cardio:claim-sprint-stopped-early", "owner": "cardio", "subject_entity_id": "cardio:sprint", "category": "descriptive", "statement": "SPRINT's blood-pressure intervention was stopped early. On 20 August 2015 the NHLBI director accepted the data and safety monitoring board's recommendation, after analyses of the primary outcome crossed the monitoring boundary at two time points in a row. Median follow-up by then was 3.26 years, against a planned average of 5 years.", "context": { "id": "cardio:ctx-sprint-adults-50plus-high-cv-risk-no-diabetes", "label": "Adults 50 and over with raised systolic blood pressure and increased cardiovascular risk, without diabetes or prior stroke (SPRINT)", "recipient": "adult", "population": "Adults aged 50 years or older with systolic blood pressure of 130 to 180 mm Hg (the registry lowers the upper limit as the number of blood-pressure medicines rises) and at least one increased-risk criterion, excluding diabetes mellitus and prior stroke.", "care_setting": "Outpatient trial clinics at 102 clinical sites. Nursing-home and assisted-living residents were not enrolled.", "geography": "United States, including Puerto Rico", "life_stage": "Adult, 50 years and over (28.2% of each arm aged 75 or over, per Table 1 of the paper)", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Median follow-up 3.26 years when the blood-pressure intervention was stopped early on 2015-08-20. The registry gives a planned maximum follow-up of 6 years. Mean systolic pressure at 1 year was 121.4 mm Hg (intensive) and 136.2 mm Hg (standard).", "eligibility": { "inclusion": [ "Age 50 years or older", "Systolic blood pressure 130 to 180 mm Hg (paper). Registry upper limits by number of blood-pressure medicines: 0 to 1 medicines 130 to 180, up to 2 medicines 130 to 170, up to 3 medicines 130 to 160, up to 4 medicines 130 to 150.", "At least one increased cardiovascular risk criterion: clinical or subclinical cardiovascular disease other than stroke; chronic kidney disease (excluding polycystic kidney disease); Framingham 10-year cardiovascular risk of 15% or greater; or older age.", "Kidney criterion, worded differently by the sources and not reconciled: paper eGFR 20 to less than 60 ml/min/1.73 m2 (4-variable MDRD); registry \"CKD, defined as eGFR 20 - 59 ml/min/1.73m2\".", "Age criterion, worded differently by the sources and not reconciled: paper \"an age of 75 years or older\"; registry \"Age greater than 75 years\".", "Sex: all (registry)" ], "exclusion": [ "Diabetes mellitus", "Prior stroke (registry: \"History of stroke (not CE or stenting)\")", "Symptomatic heart failure within 6 months or left ventricular ejection fraction below 35% (registry)", "Proteinuria above the registry thresholds", "eGFR below 20 or end-stage renal disease (registry)", "Polycystic kidney disease (registry)", "One-minute standing systolic blood pressure below 110 mm Hg (registry)", "Pregnancy or trying to become pregnant (registry)" ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "The registry gives a planned maximum follow-up of 6 years, while the paper gives a planned average of 5 years. These are different measures and are not reconciled.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 2: \"The intervention was stopped early after a median follow-up of 3.26 years owing to a significantly lower rate of the primary composite outcome\"", "applicability_note": "Abstract of the primary report, for the same population and follow-up as this context.", "snapshot": { "id": "cardio:pubmed-26551272-2026-10-09", "retrieved_at": "2026-10-09T15:56:27Z", "content_hash": "0469472c893c84018c2444c15e0a5337926968dadfdd96ad3771f84a69c4e40c", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "cardio:sprint-nejm-2015", "source_type": "publication", "title": "A Randomized Trial of Intensive versus Standard Blood-Pressure Control", "canonical_url": "https://doi.org/10.1056/NEJMoa1511939", "identifier_namespace": "doi", "identifier_value": "10.1056/NEJMoa1511939", "publication_date": "2015-11-26", "publisher": "Massachusetts Medical Society (N Engl J Med 373(22):2103-16)", "edition": "Version of record not fetched (HTTP 403). 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Full text not redistributed.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Results, Study participants, para 1: \"On August 20, 2015, the NHLBI director accepted a recommendation from the data and safety monitoring board\"", "applicability_note": "PMC author manuscript, not the version of record.", "snapshot": { "id": "cardio:pmc-pmc4689591-2026-10-09", "retrieved_at": "2026-10-09T15:57:07Z", "content_hash": "14488a091a5a65b94db2789887ceff8e32d3c89d79db5656553e4429adf44be6", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "cardio:sprint-nejm-2015", "source_type": "publication", "title": "A Randomized Trial of Intensive versus Standard Blood-Pressure Control", "canonical_url": "https://doi.org/10.1056/NEJMoa1511939", "identifier_namespace": "doi", "identifier_value": "10.1056/NEJMoa1511939", "publication_date": "2015-11-26", "publisher": "Massachusetts Medical Society (N Engl J Med 373(22):2103-16)", "edition": "Version of record not fetched (HTTP 403). 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