Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients

Summary

The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a 2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The purpose of this trial is to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal (\<130 mmHg, intensive treatment) than currently recommended (\<150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80 years of old. Furthermore, this trial will also examine the effect of blood pressure APP management strategy via WeChat network on medication compliance, blood pressure control and CVD benefits.

Timeline

Start

2017-01-15

Primary completion

2020-12-31

Completion

2021-12-31

Publications

• Background Wang Y, Peng X, Nie X, Chen L, Weldon R, Zhang W, Xiao D, Cai J. Burden of hypertension in China over the past decades: Systematic analysis of prevalence, treatment and control of hypertension. Eur J Prev Cardiol. 2016 May;23(8):792-800. doi: 10.1177/2047487315617105. Epub 2015 Nov 24.
• Background SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.
• Background ACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.
• Background Probstfield JL, Applegate WB, Borhani NO, Curb JD, Cutler JA, Davis BR, Furberg CD, Hawkins CM, Lakatos E, Page LB, et al. The Systolic Hypertension in the Elderly Program (SHEP): an intervention trial on isolated systolic hypertension. SHEP Cooperative Research Group. Clin Exp Hypertens A. 1989;11(5-6):973-89. doi: 10.3109/10641968909035386.
• Background JATOS Study Group. Principal results of the Japanese trial to assess optimal systolic blood pressure in elderly hypertensive patients (JATOS). Hypertens Res. 2008 Dec;31(12):2115-27. doi: 10.1291/hypres.31.2115.
• Zhuang M, Peng X, Song Q, Bai J, Yu M, Cai J. Systolic blood pressure time-in-target range and kidney outcomes in patients with hypertension: Findings from the STEP trial. Chin Med J (Engl). 2026 Jun 20;139(12):1821-1828. doi: 10.1097/CM9.0000000000004118. Epub 2026 May 8.
• Chen S, Ji Y, Yang R, Peng X, Bai J, Fan X, Song Q, Cai J. Influence of Baseline Smoking Status on Intensive Blood Pressure Control: Results From the STEP Randomized Trial. Can J Cardiol. 2026 Apr 21:S0828-282X(26)00361-2. doi: 10.1016/j.cjca.2026.04.005. Online ahead of print.
• Ling Q, Deng Y, Dong X, Song Q, Cai J. Effect of Hypertension Duration on the Associations Between Intensive Blood Pressure Control and Cardiac, Vascular, and Kidney Organ Damage. J Am Heart Assoc. 2026 Mar 17;15(6):e041556. doi: 10.1161/JAHA.125.041556. Epub 2026 Mar 13.
• Song Q, Peng X, Bai J, Yang R, Ling Q, Chen S, Ji Y, Dong X, Wang X, Wu S, Wang TD, Yu X, Liu H, Ren J, Zhou X, Chen R, Yang L, Yang J, Tian G, Zhang H, Zhao D, Chen F, Li D, Yu J, Zhang J, Yang Z, Zhang W, Cai J. Intensive Blood Pressure Control in Older Patients With Hypertension: 6-Year Results of the STEP Trial. J Am Coll Cardiol. 2025 Oct 28;86(17):1421-1433. doi: 10.1016/j.jacc.2025.06.045. Epub 2025 Oct 17.
• Ji Y, Peng X, Chen S, Song Q, Bai J, Cai J. Evening home pulse pressure predicted cardiovascular events and mortality in older adults with hypertension: findings based on the STEP trial. Hypertens Res. 2025 Nov;48(11):2801-2810. doi: 10.1038/s41440-025-02349-y. Epub 2025 Aug 26.
• Dong X, Bai J, Ling Q, Zhao X, Cai J. Effect of intensive blood pressure control in patients with resistant hypertension: insights from the STEP trial. Eur J Prev Cardiol. 2026 May 15;33(7):1218-1226. doi: 10.1093/eurjpc/zwaf507.
• Peng X, Olsen MH, Pareek M, Bai J, Liu Y, Song Q, Cai J. Impact of antihypertensive drug classes on cardiovascular outcomes: insights from the STEP study. BMC Med. 2025 Jul 1;23(1):365. doi: 10.1186/s12916-025-04158-z.
• Ling Q, Dong X, Bai J, Deng Y, Song Q, Cai J. Impact of Hypertension Duration on the Cardiovascular Benefit of Intensive Blood Pressure Control. Hypertension. 2024 Sep;81(9):1945-1955. doi: 10.1161/HYPERTENSIONAHA.124.23439. Epub 2024 Jul 17.
• Zhang K, Song Q, Bai J, Cai J. Association of intensive blood pressure management with cardiovascular outcomes in patients using multiple classes of antihypertensive medications: a post-hoc analysis of the STEP Trial. Hypertens Res. 2024 Jul;47(7):1779-1788. doi: 10.1038/s41440-024-01647-1. Epub 2024 Apr 10.
• Zhao S, Deng Y, Wang Y, Yu S, Han J, Cai J, Zhang Y. Incidence and prognosis of cardiac conduction system diseases in hypertension: the STEP trial. Nat Aging. 2024 Apr;4(4):483-490. doi: 10.1038/s43587-024-00591-6. Epub 2024 Mar 21.
• Yang R, Zhang J, Yu X, Yang G, Cai J. Remnant cholesterol and intensive blood pressure control in older patients with hypertension: a post hoc analysis of the STEP randomized trialdagger. Eur J Prev Cardiol. 2024 Jun 3;31(8):997-1004. doi: 10.1093/eurjpc/zwae001.
• Zhang S, Zhong Y, Wu S, Wu H, Cai J, Zhang W; STEP Study Group. Intensive blood pressure control on arterial stiffness among older patients with hypertension. Chin Med J (Engl). 2024 May 5;137(9):1078-1087. doi: 10.1097/CM9.0000000000002868. Epub 2023 Nov 15.
• Yang R, Huang R, Zhang L, Li D, Luo J, Cai J. Influence of Baseline Diastolic Blood Pressure on the Effects of Intensive Blood Pressure Lowering: Results From the STEP Randomized Trial. Hypertension. 2023 Dec;80(12):2572-2580. doi: 10.1161/HYPERTENSIONAHA.123.21892. Epub 2023 Oct 10.
• Gonzalez-Vilchez F, Hernandez-Perez F, Almenar-Bonet L, Crespo-Leiro MG, Lopez-Granados A, Ortiz-Bautista C, Delgado-Jimenez JF, de Antonio-Ferrer M, Sobrino-Marquez JM, Garcia-Romero E; Spanish Heart Transplant Teams. Spanish heart transplant registry. 34th official report of the Heart Failure Association of the Spanish Society of Cardiology. Rev Esp Cardiol (Engl Ed). 2023 Nov;76(11):901-909. doi: 10.1016/j.rec.2023.06.013. Epub 2023 Sep 6. English, Spanish.
• Wang X, Feng Y, Yang L, Zhang G, Tian X, Ling Q, Tan J, Cai J. Association of baseline serum cholesterol with benefits of intensive blood pressure control. Chin Med J (Engl). 2023 Sep 5;136(17):2058-2065. doi: 10.1097/CM9.0000000000002474.
• Deng Y, Bai J, Yang X, Liu W, Guo Z, Zhang J, Huang R, Yang X, Yu C, Yu J, Guo X, Wu H, Liu P, Zhang W, Cai J. Achieved systolic blood pressure and cardiovascular outcomes in 60-80-year-old patients: the Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial. Eur J Prev Cardiol. 2023 Aug 1;30(10):1017-1027. doi: 10.1093/eurjpc/zwad142.
• Yu J, Song Q, Bai J, Wu S, Bu P, Li Y, Cai J. Visit-to-Visit Blood Pressure Variability and Cardiovascular Outcomes in Patients Receiving Intensive Versus Standard Blood Pressure Control: Insights From the STEP Trial. Hypertension. 2023 Jul;80(7):1507-1516. doi: 10.1161/HYPERTENSIONAHA.122.20376. Epub 2023 May 12.
• Yang R, Zhu Y, Xu M, Tao Y, Cong W, Cai J. Intensive blood pressure lowering and the risk of new-onset diabetes in patients with hypertension: a post-hoc analysis of the STEP randomized trial. Eur J Prev Cardiol. 2023 Aug 1;30(10):988-995. doi: 10.1093/eurjpc/zwad105.
• Fan J, Bai J, Liu W, Cai J. Effects of intensive vs. standard blood pressure control on cognitive function: Post-hoc analysis of the STEP randomized controlled trial. Front Neurol. 2023 Feb 1;14:1042637. doi: 10.3389/fneur.2023.1042637. eCollection 2023.
• Wang XQ, Tan JS, Zhang SY, Zhang WL, Cai J. Association of serum uric acid with benefits of intensive blood pressure control. Rev Esp Cardiol (Engl Ed). 2023 Aug;76(8):635-644. doi: 10.1016/j.rec.2023.01.003. Epub 2023 Jan 28. English, Spanish.
• Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
• Ling Q, Song Q, Bai J, Wu S, Zhang W, Chen M, Cai J. Temporal Relationship Between Arterial Stiffness and Systolic Blood Pressure Under Intensive or Standard Control: A Post Hoc Analysis of the STEP Trial. Hypertension. 2022 Dec;79(12):2755-2763. doi: 10.1161/HYPERTENSIONAHA.122.20022. Epub 2022 Oct 24.
• Song Q, Ling Q, Bai J, Zhang H, Bu P, Chen F, Wu S, Zhang W, Chen M, Cai J. Influence of baseline arterial stiffness on effects of intensive compared with standard blood pressure control: a post hoc analysis of the STEP trial. BMC Med. 2022 Oct 20;20(1):358. doi: 10.1186/s12916-022-02556-1.
• Fan J, Zheng W, Liu W, Xu J, Zhou L, Liu S, Bai J, Qi Y, Huang W, Liu K, Cai J. Cost-Effectiveness of Intensive Versus Standard Blood Pressure Treatment in Older Patients With Hypertension in China. Hypertension. 2022 Nov;79(11):2631-2641. doi: 10.1161/HYPERTENSIONAHA.122.20051. Epub 2022 Sep 30.
• Zhang S, Zhong Y, Wang L, Yin X, Li Y, Liu Y, Dai Q, Tong A, Li D, Zhang L, Li P, Zhang G, Huang R, Liu J, Zhao L, Yu J, Zhang X, Yang L, Cai J, Zhang W; STEP Study Group. Anxiety, home blood pressure monitoring, and cardiovascular events among older hypertension patients during the COVID-19 pandemic. Hypertens Res. 2022 May;45(5):856-865. doi: 10.1038/s41440-022-00852-0. Epub 2022 Jan 21.
• Zhang W, Zhang S, Deng Y, Wu S, Ren J, Sun G, Yang J, Jiang Y, Xu X, Wang TD, Chen Y, Li Y, Yao L, Li D, Wang L, Shen X, Yin X, Liu W, Zhou X, Zhu B, Guo Z, Liu H, Chen X, Feng Y, Tian G, Gao X, Kario K, Cai J; STEP Study Group. Trial of Intensive Blood-Pressure Control in Older Patients with Hypertension. N Engl J Med. 2021 Sep 30;385(14):1268-1279. doi: 10.1056/NEJMoa2111437. Epub 2021 Aug 30.
• Zhang S, Zhou X, Chen Y, Wang L, Zhu B, Jiang Y, Bu P, Liu W, Li D, Li Y, Tao Y, Ren J, Fu L, Li Y, Shen X, Liu H, Sun G, Xu X, Bai J, Zhang W, Cai J; STEP Study Group. Changes in Home Blood Pressure Monitored Among Elderly Patients With Hypertension During the COVID-19 Outbreak: A Longitudinal Study in China Leveraging a Smartphone-Based Application. Circ Cardiovasc Qual Outcomes. 2021 May;14(5):e007098. doi: 10.1161/CIRCOUTCOMES.120.007098. Epub 2021 May 18.
• Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.
• Zhang S, Wu S, Ren J, Chen X, Zhang X, Feng Y, Zhou X, Zhu B, Yang J, Tian G, Jiang Y, Guo Z, Li Y, Wang TD, Kario K, Zhang W, Cai J; STEP Study Group. Strategy of blood pressure intervention in the elderly hypertensive patients (STEP): Rational, design, and baseline characteristics for the main trial. Contemp Clin Trials. 2020 Feb;89:105913. doi: 10.1016/j.cct.2019.105913. Epub 2019 Dec 12.

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Indications