The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: the Systolic Blood Pressure Intervention Trial (SPRINT).
The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: the Systolic Blood Pressure Intervention Trial (SPRINT).
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DOI：
10.1177/1740774514537404
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发表时间：
2014-10
期刊：
影响因子：
--
通讯作者：
SPRINT Study Research Group
中科院分区：
文献类型：
--
作者：
Ambrosius WT;Sink KM;Foy CG;Berlowitz DR;Cheung AK;Cushman WC;Fine LJ;Goff DC Jr;Johnson KC;Killeen AA;Lewis CE;Oparil S;Reboussin DM;Rocco MV;Snyder JK;Williamson JD;Wright JT Jr;Whelton PK;SPRINT Study Research Group
高血压是一个重要的公共卫生问题，因为它非常普遍，是不良健康后果的危险因素，包括冠心病、中风、失代偿性心力衰竭、慢性肾脏疾病和认知功能下降。观察性研究表明，血压高于115/75毫米汞柱的风险会逐渐增加。先前的研究表明，降低升高的收缩压可以降低心血管疾病后续临床并发症的风险。然而，降低血压相关不良后果的最佳收缩压尚不清楚，而且将收缩压控制在远低于140毫米汞柱的水平的益处尚未在大型、明确的临床试验中得到证实。描述收缩压干预试验(Sprint)的设计考虑因素和试验参与者的基线特征。Sprint是一项多中心、随机、对照试验，比较了两种治疗收缩压的策略：一种以140毫米汞柱的标准目标为目标，另一种以更密集的120毫米汞为目标。招募的志愿者集中在年龄为≥50岁(无上限)、平均基线收缩压≥为130 mm Hg、有心血管疾病、慢性肾脏疾病、10年Framingham心血管疾病风险评分≥15%或年龄≥75岁的志愿者。Sprint Recruitment还瞄准了三个预先指定的亚组：患有慢性肾脏疾病的参与者(估计的肾小球滤过率；60毫升/分钟/1.73平方米)，有心血管疾病病史的参与者，以及75岁或以上的参与者。主要结果是首次出现心肌梗死、急性冠脉综合征、中风、心力衰竭或心血管疾病死亡。次要结果包括全因死亡率、肾功能下降或发展为终末期肾脏疾病、偶发痴呆、认知功能下降和小血管脑缺血疾病。在2010年11月11日至2013年3月15日期间，Sprint在102家诊所招募并随机抽取了9,361人，其中包括3,333名女性、2,648名慢性肾病患者、1,877名有心血管疾病史的患者、3,962名少数民族以及2,636名75岁的≥。虽然实现了总体招聘目标，但高风险分组的招聘人数低于计划。Sprint将在不同的高危参与者样本中提供关于强化血压治疗目标的风险和好处的重要信息，这些参与者包括那些既往患有心血管疾病、慢性肾脏疾病的人和那些≥75岁的人。
High blood pressure is an important public health concern because it is highly prevalent and a risk factor for adverse health outcomes, including coronary heart disease, stroke, decompensated heart failure, chronic kidney disease, and decline in cognitive function. Observational studies show a progressive increase in risk associated with blood pressure above 115/75 mm Hg. Prior research has shown that reducing elevated systolic blood pressure lowers the risk of subsequent clinical complications from cardiovascular disease. However, the optimal systolic blood pressure to reduce blood pressure-related adverse outcomes is unclear, and the benefit of treating to a level of systolic blood pressure well below 140 mm Hg has not been proven in a large, definitive clinical trial. To describe the design considerations of the Systolic Blood Pressure Intervention Trial (SPRINT) and the baseline characteristics of trial participants. SPRINT is a multi-center, randomized, controlled trial that compares two strategies for treating systolic blood pressure: one targets the standard target of <140 mm Hg, and the other targets a more intensive target of <120 mm Hg. Enrollment focused on volunteers of age ≥50 years (no upper limit) with an average baseline systolic blood pressure ≥130 mm Hg and evidence of cardiovascular disease, chronic kidney disease, 10-year Framingham cardiovascular disease risk score ≥15%, or age ≥75 years. SPRINT recruitment also targeted three pre-specified subgroups: participants with chronic kidney disease (estimated glomerular filtration rate <60 ml/min/1.73m2), participants with a history of cardiovascular disease, and participants 75 years of age or older. The primary outcome is first occurrence of a myocardial infarction, acute coronary syndrome, stroke, heart failure, or cardiovascular disease death. Secondary outcomes include all-cause mortality, decline in kidney function or development of end-stage renal disease, incident dementia, decline in cognitive function, and small-vessel cerebral ischemic disease. Between November 11, 2010 and March 15, 2013 SPRINT recruited and randomized 9361 people at 102 clinics, including 3333 women, 2648 with chronic kidney disease, 1877 with a history of cardiovascular disease, 3962 minorities, and 2636 ≥75 years of age. Although the overall recruitment target was met, the numbers recruited in the high-risk subgroups were lower than planned. SPRINT will provide important information on the risks and benefits of intensive blood pressure treatment targets in a diverse sample of high-risk participants, including those with prior cardiovascular disease, chronic kidney disease, and those aged ≥75 years.
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影响因子：
8.3
作者：
Ay, Hakan;Benner, Thomas;Sorensen, A. Gregory
通讯作者：
Sorensen, A. Gregory
影响因子：
168.9
作者：
COLLINS, R;PETO, R;HENNEKENS, CH
通讯作者：
HENNEKENS, CH
影响因子：
9.9
作者：
GORDON, DL;BENDIXEN, BH;GORDON, DL
通讯作者：
GORDON, DL
影响因子：
158.5
作者：
Beckett, Nigel S.;Peters, Ruth;Bulpitt, Christopher J.
通讯作者：
Bulpitt, Christopher J.
影响因子：
168.9
作者：
Benavente, O. R.;Coffey, C. S.;Conwit, R.;Hart, R. G.;McClure, L. A.;Pearce, L. A.;Pergola, P. E.;Szychowski, J. M.;Benavente, O. R.;Hart, R. G.;Pergola, P. E.;Palacio, S.;Castro, I.;Farias, A.;Roldan, A.;Kase, C.;Gavras, I.;Lau, H.;Ogrodnik, M.;Allen, N.;Meissner, I.;Graves, J.;Herzig, D.;Covalt, J.;Meyer, B.;Jackson, C.;Gamble, P.;Kelly, N.;Warner, J.;Bell, J.;Demaerschalk, B.;Hogan, M.;Wochos, D.;Wieser, J.;Cleary, B.;Wood, L.;Hanna, J.;Zipp, T.;Bailey, S.;Cook, D.;Liskay, A.;Simcox, D.;Kappler, J.;Anderson, D.;Grimm, R.;Brauer, D.;Pettigrew, C.;Vaishnov, A.;Sawaya, P.;Fowler, A.;Hughes, N.;Rice, J.;Vanderpool, K.;Cruz-Flores, S.;Walden, H. D.;Holzemer, E.;Santhakumar, S.;Van Stavern, R.;Chatuverdi, S.;Flack, J.;Mada, F.;Wiseman, D.;Berlow, E.;Klinker, J.;Chiu, D.;Taylor, A.;Katz, L.;Coull, B.;Howard, L.;Malekniazi, M.;VanSkiver, M.;Bruck, D.;Redman, S.;Logan, W.;Carpenter, D.;Schroer, S.;Katramados, A.;Silver, B.;Yee, J.;Aiello, K.;Wilson, K.;McCarthy, S.;Dandapani, B.;Spies, C. P.;Vasile, C.;Anthony, B.;Ferguson, J.;Krubel, S.;Synman, A.;Andrews, N.;Kirshner, H.;Sussman, C.;Brown, D.;Elkind, M.;Crew, R. J.;Radhakrishan, J.;Corporan, T. E.;Diaz, J.;Aragon, R.;Slivka, A.;Spetie, Dan;Agriesti, J.;Notstein, P.;Naritoku, D.;Zweifler, R.;Culpepper, M.;Parnell, M.;Yunker, R.;Boots, K.;Drinkard, R.;Backlin, R.;Benesch, C.;Bisognano, J.;Leonhardt, A.;Zentner, J.;Hildreth, M.;Johnson, M.;Liu, Y.;Goldsteen, R.;Blair, A.;Wright, G.;Gathua, N.;Book, D.;Eapen, S.;Grimm, C.;Blaney, B.;Rozman, S.;Gaertner, L.;Bradenburg, E.;Loomis, L.;Monarch-Cotton, J.;Ravavelli-Meyer, J.;Golembieski, A.;Burgin, S. W.;Hollander, J.;Polashenski, W.;Wallace, P.;Weber, C.;Lutsep, H.;Girard, D.;Seisler, K.;Cingel, M.;Ross, M.;Stone, R.;Larsen, D.;Doherty, A.;David, L.;Levy, P.;Buchheimer, N.;Vaughn, S.;Smith, E.;Satterfield, J.;Tirschwell, D.;Logar, C.;Ryan, M.;Schubert, G.;Tanzai, P.;Mirsen, T.;McAllister, S.;Bastien, A.;Niblack, P.;Frey, J.;Darbonne, C.;Karanjia, P.;Murali, N.;Dart, R.;Mancl, K.;Atkinson, R.;Lieberman, R.;Carter, T.;Zrelak, P.;Kenney, N.;Jacoby, M.;Jones, D.;DeFrancisco, J.;Hamm, T.;Romano, J.;Ortiz, G.;Lichtenberger, M. del Carmen;Linas, R.;Kravet, S.;Alt, J.;Sundararajan, S.;Rahman, M.;Horvath, T.;Korosec, D.;Murphy, C.;Greenberg, J.;Lennihan, L.;King, M.;Tenteromano, L.;Frankel, M.;Doyle, J.;Braimah, J.;Pereira, L.;Ching, M.;Sawyer, R.;Parkes, K.;Conover, C.;Albakri, E.;Ramirez, G.;Segal, S.;Taylor, K.;Jackson, J.;Helgason, K.;Hillmann, M.;Ringel, R.;Fleming, N.;Mckown, B.;Cohen, S.;Jenders, R.;Singh, R.;La, M-T;Trinh, K.;Weinberger, J.;Wright, L.;Burch, D.;Horowitz, R.;Atlas, S.;Augustine, S.;Van Stavern, R.;Brown, A.;Serna, J.;Newgent, J.;Naylor, J.;Carpenter, L.;Warwick, T.;Stoltz, S.;Garcia, R.;Scheck, M.;Chadwick, L.;Fleck, J.;Weinberger, M.;Sears, A.;Fanale, C.;Neeper, L.;Fisk, P.;Cohen, S.;Sabry, D.;Phoenix, R.;Tong, D.;Garcia, M.;Mackey, A.;Morin, J.;Hache, A.;Lessard, C.;Cote, R.;Green, L.;Wadup, L.;Fontaine, A-M;Gubitz, G.;Rebello, R.;Dean, T.;Reidy, Y.;Sharma, M.;Stotts, G.;Clark, H.;Mortensen, M.;Sauve, J.;Sharma, D.;Savage, M.;Minuk, J.;Trudeau, L.;Schanz, C.;Berger, L.;Brunet, S.;Pontbriand, J.;Mainville, M.;Racicot, D.;Hill, M.;Fischer, K.;Cole-Kaskayne, A.;Keeney, C.;Shuab, A.;Khan, K.;Dean, N.;Herbert, F.;Kastelic, K.;Pretell, E. J.;Valdivia, J.;Pretell, M.;del Brutto, O.;Santibanez, R.;Lara, J.;Zambrano, M.;Arauz, A.;Cervantes, G. A.;Leyva, A.;Camacho, I.;Sandoval, J. L. Ruiz;Vasquez, E. Salcido;Ruiz, C.;Brito, C. Cantu;Fernandez, M.;Gongora-Rivera, J. F.;Escamilla, J. M.;Moxica, J.;Arciniega, G.;Gonzalez, W. J.;Matamala, G.;Goecke, H.;Parra, M.;Pozo, J.;Tapia, J.;Godoy, I. E.;Valdes, M.;Estol, C.;Peralta, C.;Ellenberg, A.;Chezzio, D.;Pardal, M. M. Fernandez;Trimachi, H.;Bonardo, P.;Mazziotti, J.;Rey, R. C.;Caruso, G.;Melamud, L.;Lepera, S.;Stilman, A. P.;Ameriso, S.;Sanchez, R.;Bruera, G.;Moschini, J.;Ramirez, M. J.;Bueri, J. A.;Sevilla, S.;de Ambrosi, B.;Marinsalta, G.;Rubio, F.;Krupinski, Y.;Carvajal, A.;Roquer, J.;Serrano, A. Oliveras;Conde, J. Jimenez;Rodriguez, A.;Romeral, G.;Arboix, A.;Pelegri, A.;Blanco, L.;Verge, D. Canovas;Herrero, J. Estela;Gomez, A.;Blanco, L.;Leal, J. S.;Castellanos, M.;Cruz, V.;Cepeda, M.;Gomis, M.;Arenillas, J.;Davalos, A.;Sunol, A.;Reverte, S.;Lluis, J.;Sergio, M. V.;Marin, M. R.;Sanchez, J. Castillo;Blanco, M.;Rodriguez, G. Manuel;Jimenez, I.;Rodriguez, J.;Tejedor, E. Diez;Martinez, P.;Fuentes, B.;Singla, L. Soler;Balaguer, E.;Izquierdo, J.;Soler, C.;Armenteros, M.;Benavente, O. R.;Hart, R. G.;Pergola, P. E.;Shepherd, A.;Roldan, A.;Benavente, M-F;White, C.;Robu, C.;Kelly, C.;Talbert, R.;Martinez, E.;Bazan, C.;Pergola, G.;Pearce, L. A.;Costello, R.;Jacova, C.;Camelia, L.;Mendoza, C.;Pratt, B.;Kin, B.;Holliday, S.;McClure, L. A.;Coffey, C.;Szychowski, M.;Howard, G.;Katholi, C.;Zhang, Yu;Peri, K.;Allcorn, C.;Mailhot, R.;Irby, L.;Guyton, F.;Sewell, M. J.;Ringer, R.;Raisch, D.;Hunt, D.;Rubio, F.;Rosso, C. M.;Martin, A.;Sanllorente, M.;Arabetti, C.;Fernandez, J. Luis;Cremona, M. J.;Capece, A.;Benavente, O. R.;Hart, R. G.;Benavente, M-F;Coffey, C.;Conwit, R.;McClure, L. A.;Pergola, P. E.;Roldan, A.;Szychowski, J. M.;Talbert, R.;Benavente, O. R.;Anderson, D.;Arauz, A.;Benavente, M-F;Coffey, C.;Conwit, R.;Cote, R.;Demaerschalk, B.;del Brutto, O.;Elkind, M.;Hart, R. G.;Kase, C.;McClure, L. A.;Moy, C.;Pergola, P. E.;Roldan, A.;Sharma, M.;Szychowski, J. M.;Talbert, R.;White, C.;White, C.;Benavente, O. R.;Benesch, C.;Coffey, C.;Conwit, R.;Graves, J.;Grimm, R.;Gubitz, G.;Holliday, S.;Lau, H.;Moy, C.;Pearce, L. A.;Szychowski, J. M.;Aguilar, M.;Sherman, D.;Nasco, E.;Blackshear, J.;Chung, M.;Fayad, P.;Gage, B.;Johnston, C.;Kernan, W.;Leira, E.;Merino, J.;Roman, G.;Sila, C.;Sung, G.;van Walraven, C.;Zweifler, R.;Stern, B.;Conwit, R.;Moy, C.;Welch, K. M.;Clarke, W.;Cutler, J.;Furie, K.;Johnston, K.;Mayo, M.
通讯作者：
Mayo, M.