The HALT Polycystic Kidney Disease Trials: Design and Implementation

被引：116

作者：

Chapman, Arlene B. ^{[1
]}

Torres, Vicente E. ^{[2
]}

Perrone, Ronald D. ^{[3
]}

Steinman, Theodore I. ^{[4
]}

Bae, Kyongtae T. ^{[5
]}

Miller, J. Philip ^{[6
]}

Miskulin, Dana C. ^{[3
]}

Oskoui, Frederic Rahbari ^{[1
]}

Masoumi, Arnirali ^{[7
]}

Hogan, Marie C. ^{[2
]}

Winklhofer, Franz T. ^{[8
]}

Braun, William ^{[9
]}

Thompson, Paul A. ^{[10
]}

Meyers, Catherine M. ^{[11
]}

Kelleher, Cass ^{[7
]}

Schrier, Robert W. ^{[7
]}

机构：

[1] Emory Univ, Sch Med, Atlanta, GA USA

[2] Mayo Coll Med, Rochester, MN USA

[3] Tufts Med Ctr, Boston, MA USA

[4] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA

[5] Univ Pittsburgh, Sch Med, Pittsburgh, PA USA

[6] Washington Univ, St Louis, MO USA

[7] Univ Colorado, Aurora, CO USA

[8] Univ Kansas, Med Ctr, Kansas City, KS 66103 USA

[9] Cleveland Clin, Cleveland, OH 44106 USA

[10] Univ S Dakota, Sioux Falls, SD USA

[11] NIDDK, NIH, Bethesda, MD USA

来源：

CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY | 2010年 / 5卷 / 01期

基金：

美国国家卫生研究院;

关键词：

CONVERTING ENZYME-INHIBITION; RENIN-ANGIOTENSIN SYSTEM; BLOOD-PRESSURE CONTROL; II RECEPTOR BLOCKER; COMBINATION THERAPY; ALDOSTERONE SYSTEM; VOLUME PROGRESSION; RENAL-DISEASE; ENALAPRIL; CREATININE;

D O I：

10.2215/CJN.04310709

中图分类号：

R5 [内科学]; R69 [泌尿科学（泌尿生殖系疾病）];

学科分类号：

1002 ; 100201 ;

摘要：

Background and objectives: Two HALT PKD trials will investigate interventions that potentially slow kidney disease progression in hypertensive autosomal dominant polycystic kidney disease (ADPKD) patients. Studies were designed in early and later stages of ADPKD to assess the impact of intensive blockade of the renin-angiotensin-aldosterone system and level of BP control on progressive renal disease. Design, settings, participants, and measurements: PKD-HALT trials are multicenter, randomized, double-blind, placebocontrolled trials studying 1018 hypertensive ADPKD patients enrolled over 3 yr with 4 to 8 yr of follow-up. In study A, 548 participants, estimated GFR (eGFR) of >60 ml/min per 1.73 m(2) were randomized to one of four arms in a 2-by-2 design: combination angiotensin converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB) therapy versus ACE monotherapy at two levels of BP control. In study B, 470 participants, eGFR of 25 to 60 ml/min per 1.73 m(2) compared ACEi/ARB therapy versus ACEi monotherapy, with BP control of 120 to 130/70 to 80 mmHg. Primary outcomes of studies A and B are MR-based percent change kidney volume and a composite endpoint of time to 50% reduction of baseline estimated eGFR, ESRD, or death, respectively. Results: This report describes design issues related to (1) novel endpoints such as kidney volume, (2) home versus office BP measures, and (3) the impact of RAAS inhibition on kidney and patient outcomes, safety, and quality of life. Conclusions: HALT PKD will evaluate potential benefits of rigorous BP control and inhibition of the renin-angiotensin-aldosterone system on kidney disease progression in ADPKD. Clin J Am Soc Nephrol 5: 102-109, 2010. doi: 10.2215/CJN.04310709

引用

页码：102 / 109

页数：8

共 45 条

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