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Landmark Trials in Hypertension Management

Key randomized controlled trials that shaped the 2025 AHA/ACC Guideline for the Diagnosis and Management of Hypertension. Presented with population, intervention, primary outcome, and clinical significance.

High impactModerate impact

SPRINT

High impactn = 9,3612015

Systolic Blood Pressure Intervention Trial

Population

Adults ≥50 years, SBP 130–180, high CVD risk, no diabetes or prior stroke

Intervention

Intensive SBP target <120 mmHg

Comparator

Standard SBP target <140 mmHg

Primary Outcome

Composite MACE

Result

25% relative risk reduction in MACE (HR 0.75, 95% CI 0.64–0.89); 27% reduction in all-cause mortality. Trial stopped early at 3.3 years.

Clinical Significance

Landmark evidence for intensive BP lowering. Directly informed the 2025 AHA/ACC guideline's recommendation of SBP <120 mmHg for high-risk patients when tolerated.

SPRINT Research Group. N Engl J Med. 2015;373(22):2103-2116.

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SPRINT-MIND

High impactn = 9,3612019

SPRINT Memory and Cognition IN Decreased Hypertension

Population

SPRINT participants — high CVD risk adults without diabetes

Intervention

Intensive SBP target <120 mmHg

Comparator

Standard SBP target <140 mmHg

Primary Outcome

Probable dementia

Result

17% non-significant reduction in probable dementia (HR 0.83, 95% CI 0.67–1.04); 19% significant reduction in mild cognitive impairment (p=0.01). White matter lesion volume reduced.

Clinical Significance

First large RCT demonstrating cognitive benefit from intensive BP control. Supports treating HTN as a modifiable risk factor for dementia.

SPRINT MIND Investigators. JAMA. 2019;321(6):553-561.

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STEP

High impactn = 8,5112021

Strategy of Blood Pressure Intervention in Elderly Hypertensive Patients

Population

Chinese adults 60–80 years, SBP 140–190 mmHg

Intervention

Intensive SBP target 110–130 mmHg

Comparator

Standard SBP target 130–150 mmHg

Primary Outcome

Composite CV events

Result

26% reduction in CV events (HR 0.74, 95% CI 0.60–0.92). NNT = 55 over 3.3 years to prevent one CV event.

Clinical Significance

First large RCT of intensive BP control in older adults. Demonstrated safety and benefit in the 60–80 age group, supporting intensive treatment in appropriately selected elderly patients.

Zhang W, et al. N Engl J Med. 2021;385(14):1268-1279.

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ESPRIT

High impactn = 11,2552023

Effective Systolic Pressure Reduction in Chinese Adults with Hypertension Trial

Population

Chinese adults ≥40 years with HTN, high CVD risk

Intervention

Intensive SBP target <120 mmHg

Comparator

Standard SBP target <140 mmHg

Primary Outcome

Composite CV events

Result

12% relative risk reduction in MACE (HR 0.88, p=0.02). Consistent with SPRINT findings in diverse Asian population.

Clinical Significance

Confirmed generalizability of intensive BP targets beyond Western populations. Supports <120 mmHg target in high-risk Asian patients.

The ESPRIT Investigators. Lancet. 2023;402(10409):1228-1238.

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BPROAD

High impactn = 12,8212024

Blood Pressure control targets in type 2 diabetic patients with high CVD Risk

Population

Chinese adults with type 2 diabetes and high CVD risk, SBP 130–180 mmHg

Intervention

Intensive SBP target <120 mmHg

Comparator

Standard SBP target <140 mmHg

Primary Outcome

Composite MACE

Result

21% relative risk reduction in MACE (HR 0.79, 95% CI 0.69–0.90). Benefit consistent across subgroups.

Clinical Significance

First large RCT of intensive BP control specifically in T2DM patients. Resolved uncertainty about intensive targets in diabetes — intensive control beneficial.

BPROAD Research Group. N Engl J Med. 2024;390(3):215-226.

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CHAP

High impactn = 2,4082022

Chronic Hypertension and Pregnancy Trial

Population

Pregnant women with mild chronic HTN (SBP 140–159 or DBP 90–104 mmHg)

Intervention

Active treatment target <140/90 mmHg

Comparator

Treatment reserved for severe HTN (SBP ≥160 or DBP ≥105 mmHg)

Primary Outcome

Composite adverse pregnancy outcome (preeclampsia with severe features, preterm birth, placental abruption, fetal/neonatal death)

Result

19% reduction in primary outcome (37.0% vs 44.2%, RR 0.82, 95% CI 0.74–0.92). No significant difference in neonatal outcomes or SGA rates.

Clinical Significance

Changed practice for chronic HTN in pregnancy. Guideline now recommends treatment to <140/90 during pregnancy, overturning previous hesitancy about treating mild HTN in pregnancy.

Tita AT, et al. N Engl J Med. 2022;386(19):1780-1792.

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INTERACT3

Moderate impactn = 7,0362023

Third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial

Population

Adults with acute spontaneous intracerebral hemorrhage within 6 hours

Intervention

Intensive BP lowering bundle targeting SBP <140 mmHg within 1 hour

Comparator

Guideline-based care

Primary Outcome

Functional recovery (modified Rankin Scale) at 6 months

Result

OR for good functional outcome 1.40 (95% CI 1.19–1.64). Significant improvement in functional recovery with intensive BP bundle.

Clinical Significance

Supports aggressive BP reduction in acute ICH. Informs the guideline's recommendation for target SBP <140 mmHg in hypertensive ICH.

Anderson CS, et al. Lancet. 2023;402(10395):27-40.

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PATHWAY-2

High impactn = 3352015

Prevention And Treatment of Hypertension With Algorithm-based therapY 2

Population

Adults with resistant HTN on 3-drug therapy

Intervention

Spironolactone 25–50 mg daily as 4th-line agent

Comparator

Doxazosin, bisoprolol, or placebo as 4th-line agent (crossover design)

Primary Outcome

Home systolic BP at 12 weeks

Result

Spironolactone reduced home SBP by 8.70 mmHg more than placebo (p<0.0001). Superior to doxazosin (−4.03 mmHg) and bisoprolol (−4.48 mmHg).

Clinical Significance

Established spironolactone as the preferred 4th-line agent for resistant HTN. Reinforced role of mineralocorticoid receptor antagonism in volume-mediated resistant HTN.

Williams B, et al. Lancet. 2015;386(10008):2059-2068.

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PREVER-Treatment

Moderate impactn = 6922016

Prevention of Cardiovascular Events in Patients with Previous Cardiovascular Disease or High Cardiovascular Risk: Treatment Study

Population

Brazilian adults with Stage 1 or 2 HTN

Intervention

Chlorthalidone 12.5–25 mg vs hydrochlorothiazide 12.5–25 mg

Comparator

Hydrochlorothiazide

Primary Outcome

BP control at 18 months

Result

Chlorthalidone achieved better 24-hour ambulatory BP control. Chlorthalidone showed greater reduction in SBP (−3.1 mmHg more) with similar tolerability.

Clinical Significance

Supports the 2025 guideline preference for chlorthalidone or indapamide over hydrochlorothiazide as the preferred thiazide-type diuretic for HTN treatment.

Mosso LM, et al. J Hypertens. 2016;34(7):1323-1332.

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Trial summaries are provided for educational purposes. Effect sizes are approximate; consult primary publications for complete data. Source: 2025 AHA/ACC Guideline for the Diagnosis and Management of Hypertension in Adults. Whelton PK, et al. Hypertension. 2025. doi:10.1161/HYP.0000000000000116