AzTrials
AzTrials

Cardiovascular DiseasesPhase 3TOPCATNCT00094302

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

A Phase 3 study testing Spironolactone in people with Cardiovascular Diseases and Heart Diseases, run by Carelon Research at 270 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Spironolactone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,445 participants
Where
270 sitesin 6 countries
Study dates
Aug 2006to Jun 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Heart failure as defined by at least one of symptom (paroxysmal nocturnal dyspnea; orthopnea; or dyspnea on mild or moderate exertion) at the time of screening and at least one sign (any rales post cough; jugular venous pressure(JVP) greater than or equal to 10cm of water(H2O); lower extremity edema; or chest x-ray demonstrating pleural effusion, pulmonary congestion, or cardiomegaly) within 12 months prior to study entry:
  • left ventricular ejection fraction greater than or equal to 45% (per local reading); the ejection fraction must have been obtained within 6 months prior to randomization and after any MI or other event that would affect ejection fraction
  • Controlled systolic blood pressure(BP), defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP
  • Serum potassium less than 5.0 mmol/L prior to randomization
  • At least one hospital admission for which heart failure was a major component of the hospitalization some time within the 12 months prior to study entry OR brain natriuretic peptide (BNP) greater than or equal to 100pg/ml or N-terminal pro-BNP greater than or equal to 360pg/ml within the 60 days prior to study entry
  • Women of child-bearing potential must have a negative serum/urine pregnancy test within 72 hours prior to randomization, must not be lactating, and must agree to use an effective method of contraception during the entire course of study participation
  • Willing to comply with scheduled visits
  • Informed consent form signed by the subject prior to participation in the trial

Who cannot join

  • Severe systemic illness with an expected life expectancy of less than 3 years
  • Chronic pulmonary disease requiring home O2, oral steroid therapy, or hospitalization for exacerbation within 12 months of study entry, or significant chronic pulmonary disease in the opinion of the investigator
  • Known infiltrative or hypertrophic obstructive cardiomyopathy or known pericardial constriction
  • Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
  • Atrial fibrillation with a resting heart rate greater than 90 bpm
  • MI in the past 90 days
Show all 22Show fewer
  • Coronary artery bypass graft surgery in the past 90 days
  • Percutaneous coronary intervention in the past 30 days
  • Heart transplant recipient
  • Currently implanted left ventricular assist device
  • Stroke in past 90 days
  • Systolic BP (SBP) greater than 160 mm Hg
  • Known orthostatic hypotension
  • Gastrointestinal disorder that could interfere with study drug absorption
  • Use of any aldosterone antagonist or potassium sparing medication in the last 14 days or any known condition that would require the use of an aldosterone antagonist during study participation;
  • Known intolerance to aldosterone antagonists
  • Current lithium use
  • Current participation (including prior 30 days) in any other therapeutic trial
  • Any condition that, in the opinion of the investigator, may prevent the participant from adhering to the trial protocol
  • History of hyperkalemia (serum potassium greater than or equal to 5.5mmol/L) in the past 6 months or serum potassium greater than or equal to 5.0mmol/L within the past 2 weeks
  • Severe renal dysfunction, defined as an estimated glomerular filtration rate(GFR) less than 30ml/min. Participants with serum creatinine greater than or equal to 2.5mg/dl are also excluded even if their GFR is greater than or equal to 30ml/min
  • Known chronic hepatic disease, defined as aspartate aminotransferase(AST) and alanine aminotransferase(ALT) levels greater than 3.0 times the upper limit of normal as read at the local lab.

Trial locations and contacts

270 sites in 6 countries.

270 sites in 6 countries

United States155 sites

  • Veterans Affairs Ann Arbor Health Care System

    Ann Arbor, Michigan, 48105

  • DCT - APHC, LLC dba Discovery Clinical Trials

    Arlington, Texas, 76014

  • Emory University at Grady Health System

    Atlanta, Georgia, 30303

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

  • Northside Cardiology Center

    Atlanta, Georgia, 30342

  • University of Colorado Health Sciences Center

    Aurora, Colorado, 80045

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Northeast Cardiology

    Bangor, Maine, 04401

  • St. Charles Health System

    Bend, Oregon, 97701

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Caritas St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Research Foundation State University of New York at Buffalo

    Buffalo, New York, 14203

  • Buffalo Heart Group, LLC

    Buffalo, New York, 14215

  • Cynthia Thaik

    Burbank, California, 91505

  • Capital Area Research

    Camp Hill, Pennsylvania, 17011

  • VAMC - Charleston, SC

    Charleston, South Carolina, 29401

  • CAMC Health Education and Research Institute

    Charleston, West Virginia, 25304

  • Merrimack Valley Cardiology Associates

    Chelmsford, Massachusetts, 01824

  • Cardiovascular Associates Ltd.

    Chesapeake, Virginia, 23320

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago Medical Center

    Chicago, Illinois, 60612

  • Northwestern University

    Chicago, Illinois, 60657

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University Hospitals of Cleveland/Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Ohio State University Hospital East

    Columbus, Ohio, 43205

  • Northeast Medical Center

    Concord, North Carolina, 28025

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Cardiovascular Research Institute of Dallas

    Dallas, Texas, 75231

  • U.T. Southwestern Medical Center

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • VAMC Dayton

    Dayton, Ohio, 45428

  • Daytona Heart Group

    Daytona Beach, Florida, 32114

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123

  • Detroit VA Medical Center

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • Compass Medical East Bridgewater

    East Bridgewater, Massachusetts, 02333

  • Cardiovascular Research Foundation

    Elk Grove Village, Illinois, 60007

  • Cardiovascular Associates of the Delaware Valley

    Elmer, New Jersey, 08318

  • Medicor Associates, Inc

    Erie, Pennsylvania, 16507

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

  • M & O Clinical Research, LLC

    Fort Lauderdale, Florida, 33316

  • Black Hills VA Health Care System

    Fort Meade, South Dakota, 57741

  • Fresno VA Medical Center

    Fresno, California, 93703

  • Florida Heart Center

    Ft. Pierce, Florida, 34950

  • University of Florida

    Gainesville, Florida, 32610

  • CCHS Clinical Research Office/Marymount Hospital

    Garfield Heights, Ohio, 44125

  • The Stern Cardiovascular Center

    Germantown, Tennessee, 38138

  • Cardiovascular Consultants, Ltd.

    Glendale, Arizona, 85306

  • Cardio-Vascular Institute

    Greeley, Colorado, 80631

  • Cardiovascular Associates of the Delaware Valley

    Haddon Heights, New Jersey, 08035

  • Pentucket Medical Associates

    Haverhill, Massachusetts, 01830

  • The Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Leonard J. Chabert Medical Center

    Houma, Louisiana, 70363

  • Michael E. DeBakey VA Medical Cntr.

    Houston, Texas, 77030

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • The Care Group, LLC

    Indianapolis, Indiana, 46260

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418

  • Glacier View Cardiology

    Kalispell, Montana, 59901

  • Mid Valley Cardiology

    Kingston, New York, 12401

  • Evergreen Healthcare

    Kirkland, Washington, 98034

  • Wilford Hall Medical Center

    Lackland City, Texas, 78236

  • Lancaster Heart and Stroke Foundation

    Lancaster, Pennsylvania, 17603

  • Kaiser Permanente

    Largo, Maryland, 20774

  • Bryan LGH Heart Institute

    Lincoln, Nebraska, 68506

  • NJ Heart

    Linden, New Jersey, 07036

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas, 72205

  • Heart Clinic Arkansas

    Little Rock, Arkansas, 72205

  • Clinica Medica San Miguel

    Los Angeles, California, 90015

  • CAPRI

    Los Angeles, California, 90048

  • VA Medical Center West Los Angeles

    Los Angeles, California, 90073

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

    Louisville, Kentucky, 40207

  • William S. Middleton Memorial VA Hospital

    Madison, Wisconsin, 53705

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792

  • InnovaMed Alliance

    Marietta, Georgia, 30060

  • CCHS Clinical Research Office/ Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Memphis VA Medical Center

    Memphis, Tennessee, 38104

  • Memphis Heart Clinic

    Memphis, Tennessee, 38120

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38163

  • Winthrop Cardiology Associates

    Mineola, New York, 11501

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • Cardiovascular Research of Northwest Indiana, LLC

    Munster, Indiana, 46321

  • LDS Hospital

    Murray, Utah, 84157

  • Vanderbilt Heart and Vascular Institute

    Nashville, Tennessee, 37232

  • Charles River Medical Associates

    Natick, Massachusetts, 01760

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Soundshore Medical Center of Westchester

    New Rochelle, New York, 10802

  • NYU School of Medicine

    New York, New York, 10016

  • St. Lukes Roosevelt

    New York, New York, 10019

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507

  • Hawthorn Medical Associates

    North Dartmouth, Massachusetts, 02747

  • Northport VA Medical Center

    Northport, New York, 11768

  • Mehrdad Kevin Ariani, MD, Inc.

    Northridge, California, 91325

  • Texas Tech University Health Sciences Center

    Odessa, Texas, 79763

  • COR Clinical Research

    Oklahoma City, Oklahoma, 73103

  • Oklahoma City VA Medical Center

    Oklahoma City, Oklahoma, 73104

  • Oklahoma Foundation for Cardiovascular Research

    Oklahoma City, Oklahoma, 73210

  • Providence St. Peter Hospital

    Olympia, Washington, 98506

  • The Creighton Cardiac Center

    Omaha, Nebraska, 68131

  • St. Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • Memorial Hospital Rhode Island

    Pawtucket, Rhode Island, 02860

  • Heart, Lung and Vascular Institute

    Peoria, Illinois, 61606

  • HeartCare Midwest

    Peoria, Illinois, 61614

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

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

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Eastwick Primary Care

    Philadelphia, Pennsylvania, 19153

  • Carl T. Hayden VA Medical Center

    Phoenix, Arizona, 85012

  • Pittsburgh VA Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • Sound Health Research

    Port Orchard, Washington, 98366

  • Providence Heart and Vascular Institute

    Portland, Oregon, 97213

  • Northwest Hospital

    Randallstown, Maryland, 21133

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • University of Rochester Medical Center

    Rochester, New York, 14618

  • Brevard Cardiovascular Research Associates, Inc

    Rockledge, Florida, 37955

  • William Beaumont Health Center

    Royal Oak, Michigan, 48073

  • UC Davis Medical Center

    Sacremento, California, 95829

  • Heartland Regional Medical Clinic

    Saint Joseph, Missouri, 64506

  • Central Coast Cardiology

    Salinas, California, 93901

  • Delmarva Heart Research Foundation

    Salisbury, Maryland, 21804

  • University of Utah

    Salt Lake City, Utah, 84132

  • Cardiology Clinic of San Antonio

    San Antonio, Texas, 78229

  • Naval Medical Center San Diego

    San Diego, California, 92134

  • University of Washington

    Seattle, Washington, 98195

  • Associates in Cardiology, PA

    Silver Spring, Maryland, 20910

  • Lewin, Fagen, and Lown, MD, PC

    Smithtown, New York, 11787

  • Electrophysiology Research Foundation

    Somerset, New Jersey, 08873

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Olive View - UCLA Medial Center

    Sylmar, California, 91342

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210

  • Syracuse VA Medical Center

    Syracuse, New York, 13210

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • Bronx-Lebanon Hospital Center

    The Bronx, New York, 10457

  • Community Medical Center

    Toms River, New Jersey, 08755

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74137

  • Tyler Cardiovascular Consultants

    Tyler, Texas, 75701

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Howard University Hospital

    Washington D.C., District of Columbia, 20060'

  • Washington DC VA Hospital

    Washington D.C., District of Columbia, 20422

  • Aspirus Heart and Vascular Institute

    Wausau, Wisconsin, 54401

  • New Jersey Cardiology Associates

    West Orange, New Jersey, 07052

  • The Reading Hospital and Medical Center

    West Reading, Pennsylvania, 19611

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Umass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Russia36 sites

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

    Barnaul, 656038

  • Municipal Health Care Institution "City Hospital #1"

    Barnaul, 656099

  • Municipal Healthcare Institution <>

    Gatchina, Leningradskaya Oblast', 188300

  • Kaliningrad Region Hospital

    Kaliningrad, Kaliningrad Oblast, 236016

  • Kemerovo Cadiologiy Dispensary, Kemerovo Medical Academy

    Kemerovo, 650002

  • Nonstate Healthcare Institution

    Kemerovo, 650036

  • State Healthcare Institution "Region Clinical Hospital #1

    Krasnodar, 350086

  • National Research Center for Preventitive Medicine

    Moscow, 101990

  • Russian State Medical University, Hospital Therapy Department #1

    Moscow, 111539

  • State Education High Professional Education Russian State Medical University

    Moscow, 115093

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

    Moscow, 129090

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

    Moscow, 777020

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

    Moscow

  • Novosibirsk Municipal Clinical Emergency Hosp. # 2

    Novosibirsk, 630008

  • Almasov research institute of Cardiology

    Saint Petersberg, 194156

  • Public Institution of Health City Hospital # 28

    Saint Petersburg, 190000

  • State Institution Saint-Petersburg Dzhanelidze Scientific

    Saint Petersburg, 192242

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

    Saint Petersburg, 193312

  • Saint-Petersburg Clinical Hospital of RAMS, policlinic department

    Saint Petersburg, 194017

  • Federal State Health Care Institution

    Saint Petersburg, 194291

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

    Saint Petersburg, 194354

  • Non-state Health Care Institution

    Saint Petersburg, 195221

  • City Hospital #26

    Saint Petersburg, 196247

  • City Hospital No 26

    Saint Petersburg, 196247

  • Chair and Department of Hospital Therapy

    Saint Petersburg, 197089

  • Medico- Military Academy, Navy Therapy Dept

    Saint Petersburg, 198013

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

    Saint Petersburg, 198205

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

    Saint Petersburg, 199106

  • Chair of Nephrology and Dialysis of St Petersburg State Medical University

    Saint Petersburg

  • Federal State Institution

    Saratov, Saratov Oblast, 410028

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

    Saratov, 410054

  • State Institition Research Institution of Cardiology of Tomsk

    Tomsk, 634012

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

    Volgograd, 400001

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

    Voronezh, 396018

  • City Healthcare Institution Clinical Hospital #8

    Yaroslavl, Yaroslavl Oblast, 150030

  • Yaroslavl Regional Clinical Hospital

    Yaroslavl, Yaroslavl Oblast, 150068

Other trials in Russia

Canada35 sites

  • University of Calgary

    Calgary, Alberta, T2N 4N1

  • Dr. Saul Vizel Cardiac Research Office

    Cambridge, Ontario, N1R 7R1

  • Cornwall Clinical Trials

    Cornwall, Ontario, K6H 4M4

  • Misericordia Hospital - Cardiac Sciences

    Edmonton

  • CHUS - Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Service de la Recherche

    Granby, Quebec, J2G 1T7

  • Dr. Gurcharan Syan (PP)

    Greater Sudbury, Ontario, P3C 5K7

  • Capital District Health Authority

    Halifax, Nova Scotia, B3H 3A7

  • Hamilton Health Sciences - General Site

    Hamilton, Ontario, L8L 2X2

  • Cite de la Sante de Laval

    Laval, Quebec, H7M 3L9

  • Clinique Cardiologie Levis

    Lévis, Quebec, G6V 4Z5

  • London Health Sciences Center

    London, Ontario, N6A 5A5

  • CDRC Rive-Sud

    Longueuil

  • Hopital Du Sacre Coeur de Montreal

    Montreal, Quebec, A4J 1C5

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • CHUM - Hotel Dieu

    Montreal, Quebec, H2W 1T8

  • Chum Hotel Dieu

    Montreal, Quebec, H2W IT8

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G IA4

  • SMBD Jewish General Hospital

    Montreal

  • Fraser Clinical Trials Inc.

    New Westminster, British Columbia, V3L 3W4

  • Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Centre de recherche clinique de Quebec

    Québec, Quebec, G1J 1Z6

  • C.S.S.S.B.

    Saint George, Quebec, G5Y 4T8

  • Centre Hosp Regional de Lanaudiere

    Sainte Charles Borromee, Quebec, J6E 6J2

  • Saskatchewan Heart Centre

    Saskatoon

  • Health Science Centre

    St. John's, Newfoundland and Labrador, AIB 3V6

  • Hopital Laval

    Ste-Foy, Quebec, GIV 4G5

  • Cardiology Clinical Trials - Surrey Memorial Hospital

    Surrey

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

    Terrebonne, Quebec, J6V 2H2

  • Centre De Sante et De Services Sociaux De Thetford

    Thetford-Mines, Quebec, G6G 2V4

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital

    Toronto, Ontario, M5G1X5

  • Centre Hospitalier de Trois-Rivieres

    Trois-Rivières

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H2A6

Other trials in Canada

Argentina18 sites

  • Instituto de Investigaciones Clinicas de Bahia Blanca

    Bahía Blanca, Buenos Aires, B80001JH

  • IMAI Research

    Buenos Aires, Buenos Aires, 1425

  • CIPREC

    Buenos Aires, Buenos Aires, C1119ACN

  • Instituto Cardiologico Ezpecializado S.R.L

    Buenos Aires, Buenos Aires, C1426 ANZ

  • Clinica IMA

    Buenos Aires, Buenos Aires, J846

  • Policlinico Modelo de Cipoletti

    Cipolletti, Río Negro Province, 8324

  • Clinica Privada Del Prado

    Córdoba, Córdoba Province, X500AAW

  • Clinica Coronel Suarez

    Coronel Suárez, Buenos Aires, b7540ghd

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, B1900 AXI

  • Instituto de Investigaciones Clinicas de Mar Del Plata

    Mar del Plata, Buenos Aires, B7600 FZN

  • Instituto de Investigaciones Clinicas de Quilmes

    Quilmes, Buenos Aires, 1878

  • Instituto de Investigaciones Clinicas de Rosario

    Rosario Santa Fe, 2000

  • Hospital San Bernardo

    Salta, Salta Province, A4406CLA

  • Centro Privado de Cardiologia

    San Miguel de Tucumán, Tucumán Province, T4000NIL

  • Centro Modelo de Cardiología

    San Miguel de Tucumán

  • Instituto de Cardiologia SRL

    San Miguel de Tucumán

  • Centro de Investigaciones Clinicas del Litoral SRL

    Santa Fe, Santa Fe Province, 3000

  • Sanatorio Mayo S.A.

    Santa Fe

Other trials in Argentina

Brazil17 sites

  • 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 de Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • 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

Other trials in Brazil

Georgia9 sites

  • L &J Clinic

    Kutaisi, 4600

  • Cardio-Reanimation Centre

    Tbilisi, K'alak'i T'bilisi, 0141

  • Tbilisi State Medical University Clinic #1

    Tbilisi, 0102

  • Cardiology Clinic

    Tbilisi, 0144

  • Multiprofile Clinical Hospital of Tbilisi #2

    Tbilisi, 0154

  • Emergency Cardiology Centre

    Tbilisi, 0159

  • National Center of Therapy

    Tbilisi, 0159

  • Diagnostic Services Clinic

    Tbilisi, 0179

  • Clinic of Angiocardiology "ADAPTI"

    Tbilisi, 0186

Other trials in Georgia

About this study

Official title: Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT)

The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function.

Read the detailed description

BACKGROUND:

Heart failure (HF) is a major cause of morbidity and mortality, particularly in older people. Indeed, it is the most common discharge diagnosis in patients older than 65 years. As the United States population ages, heart failure will continue to grow as a public health concern. Therapeutic trials of heart failure have dealt almost exclusively with patients who have systolic dysfunction. However, there is now an emerging awareness that nearly half of the patients with heart failure have preserved systolic function and that the survival of these patients is adversely affected. This study is a randomized clinical trial of a novel therapeutic approach, specifically the use of spironolactone, an aldosterone antagonist, in treating these patients. While this treatment has been shown to be useful in treating heart failure with reduced systolic function, it has not been studied in patients with preserved systolic function.

Patients with heart failure and preserved systolic function have a poor prognosis. The annual mortality rate is intermediate between the prognosis for those without heart failure and for those with heart failure and reduced systolic function. For instance, Family Health Study participants with heart failure and preserved systolic function had a mortality rate of 9% compared to 3% for their age- and gender-matched controls. The mortality rate was 19% in heart failure patients with reduced systolic function heart failure compared to 4% for their matched controls.

As heart failure develops, neurohormones are released that initially improve cardiac output but ultimately contribute to progression of left ventricular dysfunction. The renin-angiotensin-aldosterone system is an important part of this compensatory response. Aldosterone levels may rise to 20 times normal levels in heart failure and aldosterone contributes to the development of myocardial fibrosis. Spironolactone is a potassium-sparing diuretic that acts on the distal tubule, inhibiting sodium and potassium ion exchange. There are several potential beneficial actions, including prevention of cardiac fibrosis. A recent trial evaluated spironolactone in patients with systolic dysfunction heart failure. Spironolactone treatment caused a 30% reduction in mortality compared to placebo (p< 0.001). The improvement resulted from a reduction in all cause mortality. More recently, the Eplerenone Post-Myocardial Infarction (MI) study showed that this aldosterone antagonist significantly reduces mortality despite background treatment with an angiotensin-converting enzyme (ACE) inhibitor and beta-blocker. Advantages of using spironolactone in this study are that it is commercially available, inexpensive, and no longer under patent (therefore this study will not be done by industry). Also, there is a clear physiologic rationale for its use, and the side effect profile is well understood. The study enrolled subjects who had preserved systolic function with heart failure and who met clearly defined eligibility criteria that were selected to make the results widely generalizable to clinical practice.

DESIGN NARRATIVE:

This is a randomized, double-blinded, placebo-controlled trial of aldosterone antagonist therapy (15 mg dose spironolactone or placebo; titrated up to 30 or 45 mg/day) in 3,445 adult patients with heart failure and preserved systolic function. Patients were recruited from August 2006 through January 2012, treated, and will be followed through June 2013. Approximately 270 clinical sites in six countries were subcontracted by the clinical trial coordinating center. Subject visits to a clinical center will occur every four or six months. Data collected include demographic and clinical data, including the results of history and physical exams, laboratory and imaging data, repository specimens for special physiology studies, and genetic studies. Additionally, data regarding quality of life and compliance with assigned treatment will also be collected and assessed.

Being tested
Spironolactone, Placebo
Keywords
Heart Failure, Diastolic Heart Failure, Preserved Ejection Fraction
Medical subject headings
Cardiovascular Diseases, Heart Diseases, Heart Failure, Heart Failure, Diastolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpironolactoneDrug

    Also called aldosterone antagonist

    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.

  • PlaceboDrug

    Placebo of spironolactone

Study groups in NCT00094302
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo of spironolactone
Receives: Drug: Placebo
SpironolactoneExperimentalSpironolactone (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.
Receives: Drug: Spironolactone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Secondary outcomes (24)

  1. Cardiovascular Mortality

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  2. Aborted Cardiac Arrest

    First incidence of aborted cardiac arrest

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  3. Hospitalization for the Management of Heart Failure

    First incidence of a hospitalization for the management of heart failure

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  4. All-cause Mortality

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  5. Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  6. Cardiovascular-related Hospitalization

    Hospitalization for MI, stroke or the management of heart failure, whichever occurred first

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  7. Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  8. Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  9. New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline.

    First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline.

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  10. Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline.

    First incidence of atrial fibrillation among subjects without a history of atrial fibrillation at baseline

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  11. Myocardial Infarction

    First incidence of myocardial infarction

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  12. Stroke

    First incidence of stroke

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  13. Deterioration of Renal Function

    First incidence of a deterioration of renal function. The TOPCAT protocol defines deterioration of renal function as occurring if a subject has a serum creatinine value which is at least double the baseline value for that subject, and is also above the upper limit of normal (assumed to be 1.0 mg/dL for females and 1.2 mg/dL for males.)

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  14. Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  15. Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire.

    Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

    The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The KCCQ was administered at the following study visits: baseline, month 4, month 12 and annually thereafter.

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  16. Quality of Life, as Measured by the EuroQOL Visual Analog Scale.

    Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

    The EuroQOL visual analog scale (EQ5D) is a single-item, self-administered instrument that quantifies current health status. Scores can range from 0-100, in which higher scores reflect better health status. The EQ5D was administered at the following study visits: baseline, month 4, month 12 and annually thereafter.

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  17. Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire.

    Average post-baseline quality of life, taking into consideration baseline quality of life and treatment group.

    The McMaster Overall Treatment Evaluation questionnaire is a self-administered 3-item instrument that measures a patient's perception of change in their health-related quality of life since the start of therapy. The questionnaire consists of a single question - "Since treatment started, has there been any change in your activity limitation, symptoms and/or feelings related to your heart condition?" Scores can range from -7 to +7, and higher scores reflect better health status. The questionnaire was administered at the following study visits: month 4 and month 12. Valid translations of this questionnaire were only available for subjects enrolled in the United States, Canada and Argentina.

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  18. Depression Symptoms, as Measured by Patient Health Questionnaire.

    Average post-baseline depression, taking into consideration baseline depression, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

    The Patient Health Questionnaire (PHQ) is a 10-item, self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores can range from 0-27, in which lower scores reflect better mental health status. The PH-Q was administered at the following study visits: baseline, month 12 and annually thereafter. Valid translations of this questionnaire were only available for subjects enrolled in the United States and Canada.

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  19. Hospitalization for Any Reason

    First incidence of a hospitalization for any reason

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  20. Potassium

    Average post-baseline Potassium, taking into consideration baseline Potassium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  21. Serum Creatinine

    Average post-baseline serum creatinine, taking into consideration baseline serum creatinine, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  22. Sodium

    Average post-baseline Sodium, taking into consideration baseline Sodium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  23. Chloride

    Average post-baseline Chloride, taking into consideration baseline Chloride, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

  24. Estimated Glomerular Filtration Rate (GFR)

    Average post-baseline GFR, taking into consideration baseline GFR, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.

    Measured: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2004 (estimated)
  2. Study startAug 2006
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
3,445 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00094302
Sponsor's protocol ID
160
Other IDs
HHSN268200425207C
Acronym
TOPCAT
Status last verified
Jan 2014
First submitted
15 Oct 2004
Last updated
2 Mar 2015
Data monitoring committee
Yes

Publications

  • Desai AS, Lewis EF, Li R, Solomon SD, Assmann SF, Boineau R, Clausell N, Diaz R, Fleg JL, Gordeev I, McKinlay S, O'Meara E, Shaburishvili T, Pitt B, Pfeffer MA. Rationale and design of the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial: a randomized, controlled study of spironolactone in patients with symptomatic heart failure and preserved ejection fraction. Am Heart J. 2011 Dec;162(6):966-972.e10. doi: 10.1016/j.ahj.2011.09.007. Epub 2011 Nov 8.

    PubMed 22137068

  • Shah SJ, Heitner JF, Sweitzer NK, Anand IS, Kim HY, Harty B, Boineau R, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Lewis EF, Markov V, O'Meara E, Kobulia B, Shaburishvili T, Solomon SD, Pitt B, Pfeffer MA, Li R. Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial. Circ Heart Fail. 2013 Mar;6(2):184-92. doi: 10.1161/CIRCHEARTFAILURE.112.972794. Epub 2012 Dec 20.

    PubMed 23258572

  • Shah AM, Shah SJ, Anand IS, Sweitzer NK, O'Meara E, Heitner JF, Sopko G, Li G, Assmann SF, McKinlay SM, Pitt B, Pfeffer MA, Solomon SD; TOPCAT Investigators. Cardiac structure and function in heart failure with preserved ejection fraction: baseline findings from the echocardiographic study of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial. Circ Heart Fail. 2014 Jan;7(1):104-15. doi: 10.1161/CIRCHEARTFAILURE.113.000887. Epub 2013 Nov 18.

    PubMed 24249049

  • Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014 Apr 10;370(15):1383-92. doi: 10.1056/NEJMoa1313731.

    PubMed 24716680

  • Shah AM, Claggett B, Sweitzer NK, Shah SJ, Anand IS, O'Meara E, Desai AS, Heitner JF, Li G, Fang J, Rouleau J, Zile MR, Markov V, Ryabov V, Reis G, Assmann SF, McKinlay SM, Pitt B, Pfeffer MA, Solomon SD. Cardiac structure and function and prognosis in heart failure with preserved ejection fraction: findings from the echocardiographic study of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) Trial. Circ Heart Fail. 2014 Sep;7(5):740-51. doi: 10.1161/CIRCHEARTFAILURE.114.001583. Epub 2014 Aug 13.

    PubMed 25122186

  • Pfeffer MA, Claggett B, Assmann SF, Boineau R, Anand IS, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Heitner JF, Lewis EF, O'Meara E, Rouleau JL, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, McKinlay SM, Pitt B. Regional variation in patients and outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial. Circulation. 2015 Jan 6;131(1):34-42. doi: 10.1161/CIRCULATIONAHA.114.013255. Epub 2014 Nov 18.

    PubMed 25406305

  • Lu H, Claggett BL, Ostrominski JW, Pfeffer MA, Pitt B, Jhund PS, McMurray JJV, Solomon SD, Desai AS, Vaduganathan M. Time in blood pressure range and cardiovascular outcomes in HFmrEF/HFpEF: a pooled participant-level analysis of four large-scale trials. Eur J Heart Fail. 2026 Aug 30:xuag245. doi: 10.1093/ejhf/xuag245. Online ahead of print.

    PubMed 42669134

  • Nguyen DV, Nguyen HTT. Spironolactone and New-Onset Diabetes in Heart Failure: A Post Hoc Analysis of the TOPCAT Trial. JACC Asia. 2026 Jun 3:S2772-3747(26)00267-X. doi: 10.1016/j.jacasi.2026.04.010. Online ahead of print.

    PubMed 42283669

  • Beldhuis IE, Claggett BL, Neuen BL, Chatur S, Mc Causland FR, Voors AA, Desai AS, Lewis EF, Pitt B, Pfeffer MA, Solomon SD, Vaduganathan M. Spironolactone, early acute eGFR changes, and clinical outcomes in patients with heart failure with preserved ejection fraction: insights from TOPCAT Americas. Eur J Heart Fail. 2026 Sep 15;28(3):538-545. doi: 10.1093/ejhf/xuag099.

    PubMed 41961632

  • Zhu W, Guo L, Chen X, Ye M. Prognostic Utility of the HFpEF-ABA Score for HFpEF Patients: Insights From the TOPCAT Trial. JACC Adv. 2026 Mar;5(3):102632. doi: 10.1016/j.jacadv.2026.102632. Epub 2026 Feb 25.

    PubMed 41740242

  • Tang Y, Li W, Wang Z, Chu SH, Wu Y, Jia Z, Hua C, Zhang H, Liu X, Lv Q, Jiang C, Dong JZ, Ma CS, Du X. Changes in frailty based on minimally important difference and the impact of spironolactone on frailty in heart failure with preserved ejection fraction: insights from the TOPCAT trial. Open Heart. 2025 Oct 22;12(2):e003487. doi: 10.1136/openhrt-2025-003487.

    PubMed 41125402

  • Ferreira JP, Mendonca L, Marques P, Neves JS, Zannad F, Packer M. Albuminuria Is the Key Driver of Kidney Benefit with Aldosterone Receptor Antagonists in Type 2 Diabetes. J Am Soc Nephrol. 2026 Feb 1;37(2):390-393. doi: 10.1681/ASN.0000000877. Epub 2025 Sep 2. No abstract available.

    PubMed 40892478

  • Xu W, Xiao Z, Tang Y, Li Y, Chen X, He F, Huang H, Li C, Liu Y, Zhou J, Wang Y, Bin J, Chen Y. Association of serum potassium time in target range with cardiovascular outcomes in patients with HFpEF. Open Heart. 2025 Aug 21;12(2):e003439. doi: 10.1136/openhrt-2025-003439.

    PubMed 40841122

  • Ferreira JP, Zannad F. Screening for Undiagnosed Heart Failure: A Viewpoint. J Card Fail. 2025 Aug;31(8):1339-1344. doi: 10.1016/j.cardfail.2025.04.016. Epub 2025 May 23.

    PubMed 40414280

  • Xing F, Gao M, Wu Y, Liang W, Jiang J, Dong YG, Li Y, Dong B, Liu C. Influence of depression trajectories in heart failure patients with preserved ejection fractions: a secondary analysis of adverse outcomes in the TOPCAT trial. Heart. 2025 Jul 14;111(15):733-740. doi: 10.1136/heartjnl-2024-324505.

    PubMed 40089312

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Spironolactone in people with Cardiovascular Diseases and Heart Diseases, run by Carelon Research at 270 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 270 sites in United States, Russia, Canada, Argentina, Brazil and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First (time frame: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00094302, which also lists 80 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.

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