Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function

PHASE3CompletedINTERVENTIONAL
Enrollment

3,445

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Cardiovascular DiseasesHeart DiseasesHeart Failure, Congestive
Interventions
DRUG

Spironolactone

Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.

DRUG

Placebo

Placebo of spironolactone

Trial Locations (270)

1425

IMAI Research, Buenos Aires

1878

Instituto de Investigaciones Clinicas de Quilmes, Quilmes

2000

Instituto de Investigaciones Clinicas de Rosario, Rosario Santa Fe

3000

Centro de Investigaciones Clinicas del Litoral SRL, Santa Fe

4600

L &J Clinic, Kutaisi

8324

Policlinico Modelo de Cipoletti, Cipolletti

10016

NYU School of Medicine, New York

10019

St. Lukes Roosevelt, New York

10457

Bronx-Lebanon Hospital Center, The Bronx

10802

Soundshore Medical Center of Westchester, New Rochelle

11215

New York Methodist Hospital, Brooklyn

11418

Jamaica Hospital Medical Center, Jamaica

11501

Winthrop Cardiology Associates, Mineola

11768

Northport VA Medical Center, Northport

11787

Lewin, Fagen, and Lown, MD, PC, Smithtown

12401

Mid Valley Cardiology, Kingston

13210

SUNY Upstate Medical Center, Syracuse

Syracuse VA Medical Center, Syracuse

14203

Research Foundation State University of New York at Buffalo, Buffalo

14215

Buffalo Heart Group, LLC, Buffalo

14618

University of Rochester Medical Center, Rochester

15240

Pittsburgh VA Healthcare System, Pittsburgh

16507

Medicor Associates, Inc, Erie

17011

Capital Area Research, Camp Hill

17033

The Milton S. Hershey Medical Center, Hershey

17603

Lancaster Heart and Stroke Foundation, Lancaster

17822

Geisinger Medical Center, Danville

19102

Drexel University College of Medicine, Philadelphia

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University Hospital- Dept. of Family and Community Health, Philadelphia

Thomas Jefferson University, Philadelphia

19140

Temple University Hospital, Philadelphia

19153

Eastwick Primary Care, Philadelphia

19611

The Reading Hospital and Medical Center, West Reading

20010

Washington Hospital Center, Washington D.C.

20422

Washington DC VA Hospital, Washington D.C.

20774

Kaiser Permanente, Largo

20910

Associates in Cardiology, PA, Silver Spring

21133

Northwest Hospital, Randallstown

21201

University of Maryland Medical Center, Baltimore

21215

Sinai Hospital of Baltimore, Baltimore

21804

Delmarva Heart Research Foundation, Salisbury

23320

Cardiovascular Associates Ltd., Chesapeake

23507

Sentara Cardiovascular Research Institute, Norfolk

25304

CAMC Health Education and Research Institute, Charleston

27157

Wake Forest University Health Sciences, Winston-Salem

27705

Durham VA Medical Center, Durham

28025

Northeast Medical Center, Concord

29401

VAMC - Charleston, SC, Charleston

30060

InnovaMed Alliance, Marietta

30303

Emory University at Grady Health System, Atlanta

30310

Morehouse School of Medicine, Atlanta

30342

Northside Cardiology Center, Atlanta

32114

Daytona Heart Group, Daytona Beach

32224

Mayo Clinic Florida, Jacksonville

32308

Tallahassee Research Institute, Tallahassee

32610

University of Florida, Gainesville

33316

M & O Clinical Research, LLC, Fort Lauderdale

34950

Florida Heart Center, Ft. Pierce

35294

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt Heart and Vascular Institute, Nashville

37955

Brevard Cardiovascular Research Associates, Inc, Rockledge

38104

Memphis VA Medical Center, Memphis

38120

Memphis Heart Clinic, Memphis

38138

The Stern Cardiovascular Center, Germantown

38163

University of Tennessee Health Science Center, Memphis

40207

Baptist Healthcare System, Inc. d/b/a Baptist Hospital East, Louisville

43205

Ohio State University Hospital East, Columbus

44106

University Hospitals of Cleveland/Case Western Reserve University, Cleveland

44109

MetroHealth Medical Center, Cleveland

44124

CCHS Clinical Research Office/ Hillcrest Hospital, Mayfield Heights

44125

CCHS Clinical Research Office/Marymount Hospital, Garfield Heights

45219

The Lindner Clinical Trial Center, Cincinnati

45267

University of Cincinnati, Cincinnati

45428

VAMC Dayton, Dayton

46260

The Care Group, LLC, Indianapolis

46321

Cardiovascular Research of Northwest Indiana, LLC, Munster

48073

William Beaumont Health Center, Royal Oak

48105

Veterans Affairs Ann Arbor Health Care System, Ann Arbor

48123

Oakwood Hospital and Medical Center, Dearborn

48201

Detroit VA Medical Center, Detroit

48202

Henry Ford Hospital, Detroit

52242

University of Iowa Hospitals and Clinics, Iowa City

53705

William S. Middleton Memorial VA Hospital, Madison

53792

University of Wisconsin-Madison, Madison

54401

Aspirus Heart and Vascular Institute, Wausau

55417

Minneapolis VA Medical Center, Minneapolis

57741

Black Hills VA Health Care System, Fort Meade

59901

Glacier View Cardiology, Kalispell

60007

Cardiovascular Research Foundation, Elk Grove Village

60612

Rush University Medical Center, Chicago

University of Illinois at Chicago Medical Center, Chicago

60657

Northwestern University, Chicago

61606

Heart, Lung and Vascular Institute, Peoria

61614

HeartCare Midwest, Peoria

64506

Heartland Regional Medical Clinic, Saint Joseph

68131

The Creighton Cardiac Center, Omaha

68506

Bryan LGH Heart Institute, Lincoln

70121

Ochsner Clinic Foundation, New Orleans

70363

Leonard J. Chabert Medical Center, Houma

72205

Central Arkansas Veterans Healthcare System, Little Rock

Heart Clinic Arkansas, Little Rock

73103

COR Clinical Research, Oklahoma City

73104

Oklahoma City VA Medical Center, Oklahoma City

73210

Oklahoma Foundation for Cardiovascular Research, Oklahoma City

74137

Oklahoma Heart Institute, Tulsa

75216

Dallas VA Medical Center, Dallas

75231

Cardiovascular Research Institute of Dallas, Dallas

75390

U.T. Southwestern Medical Center, Dallas

75701

Tyler Cardiovascular Consultants, Tyler

76014

DCT - APHC, LLC dba Discovery Clinical Trials, Arlington

77030

Michael E. DeBakey VA Medical Cntr., Houston

The Methodist Hospital Research Institute, Houston

78229

Cardiology Clinic of San Antonio, San Antonio

78236

Wilford Hall Medical Center, Lackland City

79763

Texas Tech University Health Sciences Center, Odessa

80045

University of Colorado Health Sciences Center, Aurora

80631

Cardio-Vascular Institute, Greeley

84132

University of Utah, Salt Lake City

84157

LDS Hospital, Murray

85012

Carl T. Hayden VA Medical Center, Phoenix

85306

Cardiovascular Consultants, Ltd., Glendale

90015

Clinica Medica San Miguel, Los Angeles

90048

CAPRI, Los Angeles

90073

VA Medical Center West Los Angeles, Los Angeles

91325

Mehrdad Kevin Ariani, MD, Inc., Northridge

91342

Olive View - UCLA Medial Center, Sylmar

91505

Cynthia Thaik, Burbank

92134

Naval Medical Center San Diego, San Diego

93703

Fresno VA Medical Center, Fresno

93901

Central Coast Cardiology, Salinas

95829

UC Davis Medical Center, Sacremento

97213

Providence Heart and Vascular Institute, Portland

97701

St. Charles Health System, Bend

98034

Evergreen Healthcare, Kirkland

98195

University of Washington, Seattle

98366

Sound Health Research, Port Orchard

98506

Providence St. Peter Hospital, Olympia

101990

National Research Center for Preventitive Medicine, Moscow

111539

Russian State Medical University, Hospital Therapy Department #1, Moscow

115093

State Education High Professional Education Russian State Medical University, Moscow

129090

"Federal State Institution Outpatient clinic #3 of President's Management Department of Russian Fede", Moscow

150030

City Healthcare Institution Clinical Hospital #8, Yaroslavl

150068

Yaroslavl Regional Clinical Hospital, Yaroslavl

188300

Municipal Healthcare Institution <>, Gatchina

190000

Public Institution of Health City Hospital # 28, Saint Petersburg

192242

State Institution Saint-Petersburg Dzhanelidze Scientific, Saint Petersburg

193312

"Saint-Petersburg State Healthcare Institution City Alexander's Hospital", Saint Petersburg

194017

Saint-Petersburg Clinical Hospital of RAMS, policlinic department, Saint Petersburg

194156

Almasov research institute of Cardiology, Saint Petersberg

194291

Federal State Health Care Institution, Saint Petersburg

194354

"Saint-Petersburg State Health Care Institution City Hospital of Saint George the Martyr", Saint Petersburg

195221

Non-state Health Care Institution, Saint Petersburg

196247

City Hospital #26, Saint Petersburg

City Hospital No 26, Saint Petersburg

197089

Chair and Department of Hospital Therapy, Saint Petersburg

198013

Medico- Military Academy, Navy Therapy Dept, Saint Petersburg

198205

"Saint-Petersburg State Institution of Health Protection, City Hosptial # 15", Saint Petersburg

199106

"Saint-Petersburg State Health Institution Pokrovskaya City Hospital", Saint Petersburg

236016

Kaliningrad Region Hospital, Kaliningrad

350086

"State Healthcare Institution Region Clinical Hospital #1", Krasnodar

396018

"State Health Care Institution Voronezh Regional Clinical Consultative & Diagnostic Centre", Voronezh

400001

"State Educational institution of Higher Professional Education Volgograd State Medical University o", Volgograd

410028

Federal State Institution, Saratov

410054

State Educational Institution of High Professional Education Saratov State Medical University, Saratov

630008

Novosibirsk Municipal Clinical Emergency Hosp. # 2, Novosibirsk

634012

State Institition Research Institution of Cardiology of Tomsk, Tomsk

650002

Kemerovo Cadiologiy Dispensary, Kemerovo Medical Academy, Kemerovo

650036

Nonstate Healthcare Institution, Kemerovo

656038

Altay State Medical University of federal agency of public health and social progress RF, Barnaul

656099

"Municipal Health Care Institution City Hospital #1", Barnaul

777020

Research Institute of Physico-Chemical Medicine Center for Atheosclerosis and Laboratory, Moscow

06030

University of Connecticut Health Center, Farmington

20060'

Howard University Hospital, Washington D.C.

04401

Northeast Cardiology, Bangor

02115

Brigham and Women's Hospital, Boston

02118

Boston University Medical Center, Boston

02135

Caritas St. Elizabeth's Medical Center, Boston

01824

Merrimack Valley Cardiology Associates, Chelmsford

02333

Compass Medical East Bridgewater, East Bridgewater

01830

Pentucket Medical Associates, Haverhill

01760

Charles River Medical Associates, Natick

02747

Hawthorn Medical Associates, North Dartmouth

01199

Baystate Medical Center, Springfield

01655

Umass Memorial Medical Center, Worcester

08015

Deborah Heart and Lung Center, Browns Mills

08318

Cardiovascular Associates of the Delaware Valley, Elmer

08035

Cardiovascular Associates of the Delaware Valley, Haddon Heights

07036

NJ Heart, Linden

07503

St. Joseph's Regional Medical Center, Paterson

07450

The Valley Hospital, Ridgewood

08873

Electrophysiology Research Foundation, Somerset

08755

Community Medical Center, Toms River

07052

New Jersey Cardiology Associates, West Orange

02860

Memorial Hospital Rhode Island, Pawtucket

B80001JH

Instituto de Investigaciones Clinicas de Bahia Blanca, Bahía Blanca

C1119ACN

CIPREC, Buenos Aires

C1426 ANZ

Instituto Cardiologico Ezpecializado S.R.L, Buenos Aires

J846

Clinica IMA, Buenos Aires

b7540ghd

Clinica Coronel Suarez, Coronel Suárez

B1900 AXI

Hospital Italiano de La Plata, La Plata

B7600 FZN

Instituto de Investigaciones Clinicas de Mar Del Plata, Mar del Plata

X500AAW

Clinica Privada Del Prado, Córdoba

A4406CLA

Hospital San Bernardo, Salta

T4000NIL

Centro Privado de Cardiologia, San Miguel de Tucumán

Unknown

Centro Modelo de Cardiología, San Miguel de Tucumán

Instituto de Cardiologia SRL, San Miguel de Tucumán

Sanatorio Mayo S.A., Santa Fe

Hospital Felicio Rocho, Belo Horizonte

Santa Casa De Belo Horizonte, Belo Horizonte

HMCP PUC Campinas, Campinas

Irmandade da Santa Casa de Misericordia de Curitiba, Curitiba Parana

Hospital das Clinicas da Universidade Federal de Goias, Goiás

Instituto do Coracao de Marilia, Marilia Sao Paulo

Hospital Sao Vicente de Paulo, Passo Fundo

PROCAPE, Pernambuco

Hospital Mae De Deus, Porto Alegre

Hospital Universitario Pedro Ernesto, Rio de Janeiro

Santa Casa de Misericordia do Rio de Janeiro, Rio de Janeiro

Instituto de Cardiologia de Santa Catarina, Santa Catarina

Incor Fmusp, São Paulo

Instituto de Molestias Cardiosvaculares, São Paulo

UNIFESP/Hospital Sao Paulo, São Paulo

Instituto do Coracao do Triangulo Mineiro, Uberlândia

Misericordia Hospital - Cardiac Sciences, Edmonton

CDRC Rive-Sud, Longueuil

SMBD Jewish General Hospital, Montreal

Saskatchewan Heart Centre, Saskatoon

Cardiology Clinical Trials - Surrey Memorial Hospital, Surrey

Centre Hospitalier de Trois-Rivieres, Trois-Rivières

Non State Health Care Institution Central Hospital #6 of Russian Railways JSC, Moscow

Chair of Nephrology and Dialysis of St Petersburg State Medical University, Saint Petersburg

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

T2N 4N1

University of Calgary, Calgary

V3L 3W4

Fraser Clinical Trials Inc., New Westminster

R2H2A6

St. Boniface General Hospital, Winnipeg

AIB 3V6

Health Science Centre, St. John's

B3H 3A7

Capital District Health Authority, Halifax

N1R 7R1

Dr. Saul Vizel Cardiac Research Office, Cambridge

K6H 4M4

Cornwall Clinical Trials, Cornwall

P3C 5K7

Dr. Gurcharan Syan (PP), Greater Sudbury

L8L 2X2

Hamilton Health Sciences - General Site, Hamilton

N6A 5A5

London Health Sciences Center, London

K1Y 4W7

Ottawa Heart Institute, Ottawa

M5B 1W8

St. Michael's Hospital, Toronto

M5G1X5

Mount Sinai Hospital, Toronto

J1H 5N4

CHUS - Hopital Fleurimont, Fleurimont

J2G 1T7

Service de la Recherche, Granby

H7M 3L9

Cite de la Sante de Laval, Laval

G6V 4Z5

Clinique Cardiologie Levis, Lévis

A4J 1C5

Hopital Du Sacre Coeur de Montreal, Montreal

H1T 1C8

Montreal Heart Institute, Montreal

H2W 1T8

CHUM - Hotel Dieu, Montreal

H2W IT8

Chum Hotel Dieu, Montreal

H3A 1A1

Royal Victoria Hospital, Montreal

H3G IA4

Montreal General Hospital, Montreal

G1J 1Z6

Centre de recherche clinique de Quebec, Québec

G5Y 4T8

C.S.S.S.B., Saint George

J6E 6J2

Centre Hosp Regional de Lanaudiere, Sainte Charles Borromee

GIV 4G5

Hopital Laval, Ste-Foy

J6V 2H2

CSSS du Sud de Lanaudiere (Hopital Pierre-Le Gardeur), Terrebonne

G6G 2V4

Centre De Sante et De Services Sociaux De Thetford, Thetford-Mines

0141

Cardio-Reanimation Centre, Tbilisi

0102

Tbilisi State Medical University Clinic #1, Tbilisi

0144

Cardiology Clinic, Tbilisi

0154

Multiprofile Clinical Hospital of Tbilisi #2, Tbilisi

0159

Emergency Cardiology Centre, Tbilisi

National Center of Therapy, Tbilisi

0179

Diagnostic Services Clinic, Tbilisi

0186

"Clinic of Angiocardiology ADAPTI", Tbilisi

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Carelon Research

OTHER