Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) - Full Text View

Purpose

To determine if the combined incidence of nonfatal myocardial infarction and coronary heart disease death differs between diuretic-based and each of three alternative antihypertensive pharmacological treatments. Also, to determine, in a subset of this population, if lowering serum cholesterol with a HMG CoA reductase inhibitor in older adults reduces all-cause mortality compared to a control group receiving usual care. Conducted in conjunction with the Department of Veterans' Affairs.

Condition	Intervention	Phase
Cardiovascular Diseases Coronary Disease Diabetes Mellitus Heart Diseases Hypercholesterolemia Hypertension Myocardial Infarction Myocardial Ischemia Heart Failure	Drug: Inhibitors, ACE Drug: amlodipine Drug: lisinopril Drug: doxazosin Drug: chlorthalidone Drug: pravastatin Behavioral: diet, fat-restricted	Phase III

Genetics Home Reference related topics:

Heart Diseases Vascular Diseases hypercholesterolemia

MedlinePlus related topics:

Cholesterol Diabetes Heart Attack Heart Diseases Heart Failure High Blood Pressure

ChemIDplus related topics:

Lisinopril Pravastatin Pravastatin sodium Doxazosin Doxazosin mesylate Amlodipine Amlodipine besylate Lipids Chlorthalidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:	August 1993
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

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More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

Whelton PK, Williamson JD, Louis GT, Davis BR, Cutler JA. Experimental approaches to determining the choice of first-step therapy for patients with hypertension. The ALLHAT Research Group Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Clin Exp Hypertens. 1996 Apr-May;18(3-4):569-79. Review.

Elliott WJ. ALLHAT: the largest and most important clinical trial in hypertension ever done in the USA. Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial. Am J Hypertens. 1996 Apr;9(4 Pt 1):409-11. No abstract available.

Saunders E. Recruitment of African-American patients for clinical trials--the Allhat challenges. Antihypertensive and Lipid-lowering Trial to Prevent Heart Attack. J Natl Med Assoc. 1995 Aug;87(8 Suppl):627-9. No abstract available.

Manolio TA, Cutler JA, Furberg CD, Psaty BM, Whelton PK, Applegate WB. Trends in pharmacologic management of hypertension in the United States. Arch Intern Med. 1995 Apr 24;155(8):829-37. Review.

Davis BR, Cutler JA, Gordon DJ, Furberg CD, Wright JT Jr, Cushman WC, Grimm RH, LaRosa J, Whelton PK, Perry HM, Alderman MH, Ford CE, Oparil S, Francis C, Proschan M, Pressel S, Black HR, Hawkins CM. Rationale and design for the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT Research Group. Am J Hypertens. 1996 Apr;9(4 Pt 1):342-60.

Conlin PR, Williams GH. Use of calcium channel blockers in hypertension. Adv Intern Med. 1998;43:533-62. Review.

Anderson RJ, Alonso K. The ALLHAT challenges. J Natl Med Assoc. 1996 Jun;88(6):335, 368. No abstract available.

Messerli FH. What, if anything, is controversial about calcium antagonists? Am J Hypertens. 1996 Dec;9(12 Pt 2):177S-181S. Review.

Proschan M, Davis B, Cutler J, Ford C, Furberg C, Grimm R, Oparil S. ALLHAT and calcium channel blockers. ALLHAT Research Group. Am J Hypertens. 1997 Jan;10(1):142-3. No abstract available.

Cutler JA. Calcium-channel blockers for hypertension--uncertainty continues. N Engl J Med. 1998 Mar 5;338(10):679-81. No abstract available.

SoRelle R. National Heart, Lung, and Blood Institute halts part of antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT) Circulation. 2000 Mar 28;101(12):E9025. No abstract available.

Messerli FH. Implications of discontinuation of doxazosin arm of ALLHAT. Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Lancet. 2000 Mar 11;355(9207):863-4. No abstract available.

[No authors listed] Major cardiovascular events in hypertensive patients randomized to doxazosin vs chlorthalidone: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). ALLHAT Collaborative Research Group. JAMA. 2000 Apr 19;283(15):1967-75. Erratum in: JAMA 2002 Dec 18;288(23):2976.

Lasagna L. Diuretics vs alpha-blockers for treatment of hypertension: lessons from ALLHAT. Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. JAMA. 2000 Apr 19;283(15):2013-4. No abstract available.

Pressel SL, Davis BR, Wright JT, Geraci TS, Kingry C, Ford CE, Piller LB, Bettencourt J, Kimmel B, Lusk C, Parks H, Simpson LM, Nwachuku C, Furberg CD. Operational aspects of terminating the doxazosin arm of The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Control Clin Trials. 2001 Feb;22(1):29-41.

Grimm RH Jr, Margolis KL, Papademetriou V V, Cushman WC, Ford CE, Bettencourt J, Alderman MH, Basile JN, Black HR, DeQuattro V V, Eckfeldt J, Hawkins CM, Perry HM Jr, Proschan M. Baseline Characteristics of Participants in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Hypertension. 2001 Jan;37(1):19-27.

Barzilay JI, Jones CL, Davis BR, Basile JN, Goff DC Jr, Ciocon JO, Sweeney ME, Randall OS. Baseline characteristics of the diabetic participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Diabetes Care. 2001 Apr;24(4):654-8.

Wright JT Jr, Cushman WC, Davis BR, Barzilay J, Colon P, Egan D, Lucente T, Nwachuku C, Pressel S, Leenen FH, Frolkis J, Letterer R, Walsh S, Tobin JN, Deger GE. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT): clinical center recruitment experience. Control Clin Trials. 2001 Dec;22(6):659-73.

Pressel S, Davis BR, Louis GT, Whelton P, Adrogue H, Egan D, Farber M, Payne G, Probstfield J, Ward H. Participant recruitment in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Control Clin Trials. 2001 Dec;22(6):674-86.

Cushman WC, Ford CE, Cutler JA, Margolis KL, Davis BR, Grimm RH, Black HR, Hamilton BP, Holland J, Nwachuku C, Papademetriou V, Probstfield J, Wright JT Jr, Alderman MH, Weiss RJ, Piller L, Bettencourt J, Walsh SM. Success and predictors of blood pressure control in diverse North American settings: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). J Clin Hypertens (Greenwich). 2002 Nov-Dec;4(6):393-405.

Piller LB, Davis BR, Cutler JA, Cushman WC, Wright JT Jr, Williamson JD, Leenen FH, Einhorn PT, Randall OS, Golden JS, Haywood LJ, . Validation of Heart Failure Events in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Participants Assigned to Doxazosin and Chlorthalidone. Curr Control Trials Cardiovasc Med. 2002 Nov 14 [epub ahead of print]

Pasternak RC. The ALLHAT Lipid Lowering Trial-Less Is Less. JAMA. 2002 Dec 18;288(23):3042-4. No abstract available.

Appel LJ. The verdict from ALLHAT--thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002 Dec 18;288(23):3039-42. No abstract available.

[No authors listed] Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). JAMA. 2002 Dec 18;288(23):2998-3007.

[No authors listed] Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002 Dec 18;288(23):2981-97.

Flack JM, Nasser SA. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Major outomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic. Curr Hypertens Rep. 2003 Jun;5(3):189-191. No abstract available.

Papademetriou V, Piller LB, Ford CE, Gordon D, Hartney TJ, Geraci TS, Reisin E, Sumner BM, Wong ND, Nwachuku C, Narayan P, Haywood J, Habib G; ALLHAT Collaborative Research Group. Characteristics and lipid distribution of a large, high-risk, hypertensive population: the lipid-lowering component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). J Clin Hypertens (Greenwich). 2003 Nov-Dec; 5(6): 377-84.

Rahman M, Brown CD, Coresh J, Davis BR, Eckfeldt JH, Kopyt N, Levey AS, Nwachuku C, Pressel S, Reisin E, Walworth C; Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial Collaborative Research Group. The prevalence of reduced glomerular filtration rate in older hypertensive patients and its association with cardiovascular disease: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Arch Intern Med. 2004 May 10;164(9):969-76.

Farag A, Bahtiyar G, Rothman J, McFarlane SI. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack (ALLHAT) Trial: Focus on the Diabetic Patient. Curr Hypertens Rep. 2004 Jun;6(3):212-4. No abstract available.

Barzilay JI, Davis BR, Bettencourt J, Margolis KL, Goff DC Jr, Black H, Habib G, Ellsworth A, Force RW, Wiegmann T, Ciocon JO, Basile JN; ALLHAT Collaborative Research Group. Cardiovascular outcomes using doxazosin vs. chlorthalidone for the treatment of hypertension in older adults with and without glucose disorders: a report from the ALLHAT study. J Clin Hypertens (Greenwich). 2004 Mar;6(3):116-25.

Davis BR, Furberg CD, Wright JT Jr, Cutler JA, Whelton P; ALLHAT Collaborative Research Group. ALLHAT: setting the record straight. Ann Intern Med. 2004 Jul 6;141(1):39-46.

Geraci TS, Geraci SA. What ALLHAT tells us about treating high-risk patients with hypertension and hyperlipidemia. J Cardiovasc Nurs. 2003 Nov-Dec;18(5):389-95. Review.

Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial Collaborative Research Group. Diuretic versus alpha-blocker as first-step antihypertensive therapy: final results from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Hypertension. 2003 Sep;42(3):239-46. Epub 2003 Aug 18.

Davis BR, Cutler JA, Furberg CD, Wright JT, Farber MA, Felicetta JV, Stokes JD; ALLHAT Collaborative Research Group. Relationship of antihypertensive treatment regimens and change in blood pressure to risk for heart failure in hypertensive patients randomly assigned to doxazosin or chlorthalidone: further analyses from the Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial. Ann Intern Med. 2002 Sep 3;137(5 Part 1):313-20. Summary for patients in: Ann Intern Med. 2002 Sep 3;137(5 Part 1):I38.

Wright JT Jr, Dunn JK, Cutler JA, Davis BR, Cushman WC, Ford CE, Haywood LJ, Leenen FH, Margolis KL, Papademetriou V, Probstfield JL, Whelton PK, Habib GB; ALLHAT Collaborative Research Group. Outcomes in hypertensive black and nonblack patients treated with chlorthalidone, amlodipine, and lisinopril. JAMA. 2005 Apr 6;293(13):1595-608.

Rahman M, Pressel S, Davis BR, Nwachuku C, Wright JT Jr, Whelton PK, Barzilay J, Batuman V, Eckfeldt JH, Farber M, Henriquez M, Kopyt N, Louis GT, Saklayen M, Stanford C, Walworth C, Ward H, Wiegmann T. Renal outcomes in high-risk hypertensive patients treated with an angiotensin-converting enzyme inhibitor or a calcium channel blocker vs a diuretic: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Arch Intern Med. 2005 Apr 25;165(8):936-46.

Whelton PK, Barzilay J, Cushman WC, Davis BR, Iiamathi E, Kostis JB, Leenen FH, Louis GT, Margolis KL, Mathis DE, Moloo J, Nwachuku C, Panebianco D, Parish DC, Pressel S, Simmons DL, Thadani U; ALLHAT Collaborative Research Group. Clinical outcomes in antihypertensive treatment of type 2 diabetes, impaired fasting glucose concentration, and normoglycemia: Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Arch Intern Med. 2005 Jun 27;165(12):1401-9.

Rahman M, Pressel S, Davis BR, Nwachuku C, Wright JT Jr, Whelton PK, Barzilay J, Batuman V, Eckfeldt JH, Farber MA, Franklin S, Henriquez M, Kopyt N, Louis GT, Saklayen M, Stanford C, Walworth C, Ward H, Wiegmann T; ALLHAT Collaborative Research Group. Cardiovascular outcomes in high-risk hypertensive patients stratified by baseline glomerular filtration rate. Ann Intern Med. 2006 Feb 7;144(3):172-80. Summary for patients in: Ann Intern Med. 2006 Feb 7;144(3):I33.

Publications indexed to this study:

Wright JT Jr, Harris-Haywood S, Pressel S, Barzilay J, Baimbridge C, Bareis CJ, Basile JN, Black HR, Dart R, Gupta AK, Hamilton BP, Einhorn PT, Haywood LJ, Jafri SZ, Louis GT, Whelton PK, Scott CL, Simmons DL, Stanford C, Davis BR. Clinical outcomes by race in hypertensive patients with and without the metabolic syndrome: Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Arch Intern Med. 2008 Jan 28;168(2):207-17.

Black HR, Davis B, Barzilay J, Nwachuku C, Baimbridge C, Marginean H, Wright JT Jr, Basile J, Wong ND, Whelton P, Dart RA, Thadani U; Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Metabolic and clinical outcomes in nondiabetic individuals with the metabolic syndrome assigned to chlorthalidone, amlodipine, or lisinopril as initial treatment for hypertension: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Diabetes Care. 2008 Feb;31(2):353-60. Epub 2007 Nov 13.

Margolis KL, Piller LB, Ford CE, Henriquez MA, Cushman WC, Einhorn PT, Colon PJ Sr, Vidt DG, Christian R, Wong ND, Wright JT Jr, Goff DC Jr; Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial Collaborative Research Group. Blood pressure control in Hispanics in the antihypertensive and lipid-lowering treatment to prevent heart attack trial. Hypertension. 2007 Nov;50(5):854-61. Epub 2007 Sep 10.

Davis BR, Piller LB, Cutler JA, Furberg C, Dunn K, Franklin S, Goff D, Leenen F, Mohiuddin S, Papademetriou V, Proschan M, Ellsworth A, Golden J, Colon P, Crow R; Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial Collaborative Research Group. Role of diuretics in the prevention of heart failure: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Circulation. 2006 May 9;113(18):2201-10. Epub 2006 May 1.

Study ID Numbers:	85
First Received:	October 27, 1999
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00000542
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Myocardial Ischemia

Pravastatin

Necrosis

Hypercholesterolemia

Myocardial Infarction

Dyslipidemias

Heart Failure

Metabolic Diseases

Heart Diseases

Hyperlipidemias

Lisinopril

Vascular Diseases

Diabetes Mellitus

Endocrine System Diseases

Ischemia

Doxazosin

Amlodipine

Coronary Disease

Chlorthalidone

Endocrinopathy

Additional relevant MeSH terms:

Antimetabolites

Vasodilator Agents

Molecular Mechanisms of Pharmacological Action

Cardiotonic Agents

Antilipemic Agents

Sodium Chloride Symporter Inhibitors

Diuretics

Physiological Effects of Drugs

Calcium Channel Blockers

Enzyme Inhibitors

Anticholesteremic Agents

Cardiovascular Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Antihypertensive Agents

Protective Agents

Pharmacologic Actions

Protease Inhibitors

Membrane Transport Modulators

Pathologic Processes

Natriuretic Agents

ClinicalTrials.gov processed this record on July 08, 2008

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000542


Investigator:	Barry Davis	University of Texas