Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function
TOPCAT
Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT)
2 other identifiers
interventional
3,445
6 countries
270
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 cardiovascular-diseases
Started Aug 2006
Typical duration for phase_3 cardiovascular-diseases
270 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2004
CompletedFirst Posted
Study publicly available on registry
October 15, 2004
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
March 2, 2015
CompletedMarch 2, 2015
January 1, 2014
6.8 years
October 15, 2004
December 1, 2014
February 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First
Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
Secondary Outcomes (24)
Cardiovascular Mortality
Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
Aborted Cardiac Arrest
Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
Hospitalization for the Management of Heart Failure
Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
All-cause Mortality
Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
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
Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
- +19 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo of spironolactone
Spironolactone
EXPERIMENTALSpironolactone (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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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;
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (270)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Cardiovascular Consultants, Ltd.
Glendale, Arizona, 85306, United States
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012, United States
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205, United States
Heart Clinic Arkansas
Little Rock, Arkansas, 72205, United States
Cynthia Thaik
Burbank, California, 91505, United States
Fresno VA Medical Center
Fresno, California, 93703, United States
Clinica Medica San Miguel
Los Angeles, California, 90015, United States
CAPRI
Los Angeles, California, 90048, United States
VA Medical Center West Los Angeles
Los Angeles, California, 90073, United States
Mehrdad Kevin Ariani, MD, Inc.
Northridge, California, 91325, United States
UC Davis Medical Center
Sacremento, California, 95829, United States
Central Coast Cardiology
Salinas, California, 93901, United States
Naval Medical Center San Diego
San Diego, California, 92134, United States
Olive View - UCLA Medial Center
Sylmar, California, 91342, United States
University of Colorado Health Sciences Center
Aurora, Colorado, 80045, United States
Cardio-Vascular Institute
Greeley, Colorado, 80631, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Howard University Hospital
Washington D.C., District of Columbia, 20060', United States
Washington DC VA Hospital
Washington D.C., District of Columbia, 20422, United States
Daytona Heart Group
Daytona Beach, Florida, 32114, United States
M & O Clinical Research, LLC
Fort Lauderdale, Florida, 33316, United States
Florida Heart Center
Ft. Pierce, Florida, 34950, United States
University of Florida
Gainesville, Florida, 32610, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Brevard Cardiovascular Research Associates, Inc
Rockledge, Florida, 37955, United States
Tallahassee Research Institute
Tallahassee, Florida, 32308, United States
Emory University at Grady Health System
Atlanta, Georgia, 30303, United States
Morehouse School of Medicine
Atlanta, Georgia, 30310, United States
Northside Cardiology Center
Atlanta, Georgia, 30342, United States
InnovaMed Alliance
Marietta, Georgia, 30060, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois at Chicago Medical Center
Chicago, Illinois, 60612, United States
Northwestern University
Chicago, Illinois, 60657, United States
Cardiovascular Research Foundation
Elk Grove Village, Illinois, 60007, United States
Heart, Lung and Vascular Institute
Peoria, Illinois, 61606, United States
HeartCare Midwest
Peoria, Illinois, 61614, United States
The Care Group, LLC
Indianapolis, Indiana, 46260, United States
Cardiovascular Research of Northwest Indiana, LLC
Munster, Indiana, 46321, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Baptist Healthcare System, Inc. d/b/a Baptist Hospital East
Louisville, Kentucky, 40207, United States
Leonard J. Chabert Medical Center
Houma, Louisiana, 70363, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Northeast Cardiology
Bangor, Maine, 04401, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Kaiser Permanente
Largo, Maryland, 20774, United States
Northwest Hospital
Randallstown, Maryland, 21133, United States
Delmarva Heart Research Foundation
Salisbury, Maryland, 21804, United States
Associates in Cardiology, PA
Silver Spring, Maryland, 20910, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
Merrimack Valley Cardiology Associates
Chelmsford, Massachusetts, 01824, United States
Compass Medical East Bridgewater
East Bridgewater, Massachusetts, 02333, United States
Pentucket Medical Associates
Haverhill, Massachusetts, 01830, United States
Charles River Medical Associates
Natick, Massachusetts, 01760, United States
Hawthorn Medical Associates
North Dartmouth, Massachusetts, 02747, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Umass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Veterans Affairs Ann Arbor Health Care System
Ann Arbor, Michigan, 48105, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123, United States
Detroit VA Medical Center
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
William Beaumont Health Center
Royal Oak, Michigan, 48073, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417, United States
Heartland Regional Medical Clinic
Saint Joseph, Missouri, 64506, United States
Glacier View Cardiology
Kalispell, Montana, 59901, United States
Bryan LGH Heart Institute
Lincoln, Nebraska, 68506, United States
The Creighton Cardiac Center
Omaha, Nebraska, 68131, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015, United States
Cardiovascular Associates of the Delaware Valley
Elmer, New Jersey, 08318, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035, United States
NJ Heart
Linden, New Jersey, 07036, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Electrophysiology Research Foundation
Somerset, New Jersey, 08873, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
New Jersey Cardiology Associates
West Orange, New Jersey, 07052, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Research Foundation State University of New York at Buffalo
Buffalo, New York, 14203, United States
Buffalo Heart Group, LLC
Buffalo, New York, 14215, United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418, United States
Mid Valley Cardiology
Kingston, New York, 12401, United States
Winthrop Cardiology Associates
Mineola, New York, 11501, United States
Soundshore Medical Center of Westchester
New Rochelle, New York, 10802, United States
NYU School of Medicine
New York, New York, 10016, United States
St. Lukes Roosevelt
New York, New York, 10019, United States
Northport VA Medical Center
Northport, New York, 11768, United States
University of Rochester Medical Center
Rochester, New York, 14618, United States
Lewin, Fagen, and Lown, MD, PC
Smithtown, New York, 11787, United States
SUNY Upstate Medical Center
Syracuse, New York, 13210, United States
Syracuse VA Medical Center
Syracuse, New York, 13210, United States
Bronx-Lebanon Hospital Center
The Bronx, New York, 10457, United States
Northeast Medical Center
Concord, North Carolina, 28025, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University Hospitals of Cleveland/Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Ohio State University Hospital East
Columbus, Ohio, 43205, United States
VAMC Dayton
Dayton, Ohio, 45428, United States
CCHS Clinical Research Office/Marymount Hospital
Garfield Heights, Ohio, 44125, United States
CCHS Clinical Research Office/ Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
COR Clinical Research
Oklahoma City, Oklahoma, 73103, United States
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73210, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74137, United States
St. Charles Health System
Bend, Oregon, 97701, United States
Providence Heart and Vascular Institute
Portland, Oregon, 97213, United States
Capital Area Research
Camp Hill, Pennsylvania, 17011, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Medicor Associates, Inc
Erie, Pennsylvania, 16507, United States
The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Lancaster Heart and Stroke Foundation
Lancaster, Pennsylvania, 17603, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital- Dept. of Family and Community Health
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Eastwick Primary Care
Philadelphia, Pennsylvania, 19153, United States
Pittsburgh VA Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
The Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611, United States
Memorial Hospital Rhode Island
Pawtucket, Rhode Island, 02860, United States
VAMC - Charleston, SC
Charleston, South Carolina, 29401, United States
Black Hills VA Health Care System
Fort Meade, South Dakota, 57741, United States
The Stern Cardiovascular Center
Germantown, Tennessee, 38138, United States
Memphis VA Medical Center
Memphis, Tennessee, 38104, United States
Memphis Heart Clinic
Memphis, Tennessee, 38120, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, 37232, United States
DCT - APHC, LLC dba Discovery Clinical Trials
Arlington, Texas, 76014, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Cardiovascular Research Institute of Dallas
Dallas, Texas, 75231, United States
U.T. Southwestern Medical Center
Dallas, Texas, 75390, United States
Michael E. DeBakey VA Medical Cntr.
Houston, Texas, 77030, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
Wilford Hall Medical Center
Lackland City, Texas, 78236, United States
Texas Tech University Health Sciences Center
Odessa, Texas, 79763, United States
Cardiology Clinic of San Antonio
San Antonio, Texas, 78229, United States
Tyler Cardiovascular Consultants
Tyler, Texas, 75701, United States
LDS Hospital
Murray, Utah, 84157, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Cardiovascular Associates Ltd.
Chesapeake, Virginia, 23320, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507, United States
Evergreen Healthcare
Kirkland, Washington, 98034, United States
Providence St. Peter Hospital
Olympia, Washington, 98506, United States
Sound Health Research
Port Orchard, Washington, 98366, United States
University of Washington
Seattle, Washington, 98195, United States
CAMC Health Education and Research Institute
Charleston, West Virginia, 25304, United States
William S. Middleton Memorial VA Hospital
Madison, Wisconsin, 53705, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53792, United States
Aspirus Heart and Vascular Institute
Wausau, Wisconsin, 54401, United States
Instituto de Investigaciones Clinicas de Bahia Blanca
Bahía Blanca, Buenos Aires, B80001JH, Argentina
IMAI Research
Buenos Aires, Buenos Aires, 1425, Argentina
CIPREC
Buenos Aires, Buenos Aires, C1119ACN, Argentina
Instituto Cardiologico Ezpecializado S.R.L
Buenos Aires, Buenos Aires, C1426 ANZ, Argentina
Clinica IMA
Buenos Aires, Buenos Aires, J846, Argentina
Clinica Coronel Suarez
Coronel Suárez, Buenos Aires, b7540ghd, Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires, B1900 AXI, Argentina
Instituto de Investigaciones Clinicas de Mar Del Plata
Mar del Plata, Buenos Aires, B7600 FZN, Argentina
Instituto de Investigaciones Clinicas de Quilmes
Quilmes, Buenos Aires, 1878, Argentina
Clinica Privada Del Prado
Córdoba, Córdoba Province, X500AAW, Argentina
Policlinico Modelo de Cipoletti
Cipolletti, Río Negro Province, 8324, Argentina
Hospital San Bernardo
Salta, Salta Province, A4406CLA, Argentina
Centro de Investigaciones Clinicas del Litoral SRL
Santa Fe, Santa Fe Province, 3000, Argentina
Centro Privado de Cardiologia
San Miguel de Tucumán, Tucumán Province, T4000NIL, Argentina
Instituto de Investigaciones Clinicas de Rosario
Rosario Santa Fe, 2000, Argentina
Centro Modelo de Cardiología
San Miguel de Tucumán, Argentina
Instituto de Cardiologia SRL
San Miguel de Tucumán, Argentina
Sanatorio Mayo S.A.
Santa Fe, Argentina
Hospital Felicio Rocho
Belo Horizonte, Brazil
Santa Casa De Belo Horizonte
Belo Horizonte, Brazil
HMCP PUC Campinas
Campinas, Brazil
Irmandade da Santa Casa de Misericordia de Curitiba
Curitiba Parana, Brazil
Hospital das Clinicas da Universidade Federal de Goias
Goiás, Brazil
Instituto do Coracao de Marilia
Marilia Sao Paulo, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, Brazil
PROCAPE
Pernambuco, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Hospital Mae De Deus
Porto Alegre, Brazil
Hospital Universitario Pedro Ernesto
Rio de Janeiro, Brazil
Santa Casa de Misericordia do Rio de Janeiro
Rio de Janeiro, Brazil
Instituto de Cardiologia de Santa Catarina
Santa Catarina, Brazil
Incor Fmusp
São Paulo, Brazil
Instituto de Molestias Cardiosvaculares
São Paulo, Brazil
UNIFESP/Hospital Sao Paulo
São Paulo, Brazil
Instituto do Coracao do Triangulo Mineiro
Uberlândia, Brazil
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
Fraser Clinical Trials Inc.
New Westminster, British Columbia, V3L 3W4, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, R2H2A6, Canada
Health Science Centre
St. John's, Newfoundland and Labrador, AIB 3V6, Canada
Capital District Health Authority
Halifax, Nova Scotia, B3H 3A7, Canada
Dr. Saul Vizel Cardiac Research Office
Cambridge, Ontario, N1R 7R1, Canada
Cornwall Clinical Trials
Cornwall, Ontario, K6H 4M4, Canada
Dr. Gurcharan Syan (PP)
Greater Sudbury, Ontario, P3C 5K7, Canada
Hamilton Health Sciences - General Site
Hamilton, Ontario, L8L 2X2, Canada
London Health Sciences Center
London, Ontario, N6A 5A5, Canada
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G1X5, Canada
CHUS - Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4, Canada
Service de la Recherche
Granby, Quebec, J2G 1T7, Canada
Cite de la Sante de Laval
Laval, Quebec, H7M 3L9, Canada
Clinique Cardiologie Levis
Lévis, Quebec, G6V 4Z5, Canada
Hopital Du Sacre Coeur de Montreal
Montreal, Quebec, A4J 1C5, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
CHUM - Hotel Dieu
Montreal, Quebec, H2W 1T8, Canada
Chum Hotel Dieu
Montreal, Quebec, H2W IT8, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Montreal General Hospital
Montreal, Quebec, H3G IA4, Canada
Centre de recherche clinique de Quebec
Québec, Quebec, G1J 1Z6, Canada
C.S.S.S.B.
Saint George, Quebec, G5Y 4T8, Canada
Centre Hosp Regional de Lanaudiere
Sainte Charles Borromee, Quebec, J6E 6J2, Canada
Hopital Laval
Ste-Foy, Quebec, GIV 4G5, Canada
CSSS du Sud de Lanaudiere (Hopital Pierre-Le Gardeur)
Terrebonne, Quebec, J6V 2H2, Canada
Centre De Sante et De Services Sociaux De Thetford
Thetford-Mines, Quebec, G6G 2V4, Canada
Misericordia Hospital - Cardiac Sciences
Edmonton, Canada
CDRC Rive-Sud
Longueuil, Canada
SMBD Jewish General Hospital
Montreal, Canada
Saskatchewan Heart Centre
Saskatoon, Canada
Cardiology Clinical Trials - Surrey Memorial Hospital
Surrey, Canada
Centre Hospitalier de Trois-Rivieres
Trois-Rivières, Canada
Cardio-Reanimation Centre
Tbilisi, K'alak'i T'bilisi, 0141, Georgia
L &J Clinic
Kutaisi, 4600, Georgia
Tbilisi State Medical University Clinic #1
Tbilisi, 0102, Georgia
Cardiology Clinic
Tbilisi, 0144, Georgia
Multiprofile Clinical Hospital of Tbilisi #2
Tbilisi, 0154, Georgia
Emergency Cardiology Centre
Tbilisi, 0159, Georgia
National Center of Therapy
Tbilisi, 0159, Georgia
Diagnostic Services Clinic
Tbilisi, 0179, Georgia
Clinic of Angiocardiology "ADAPTI"
Tbilisi, 0186, Georgia
Kaliningrad Region Hospital
Kaliningrad, Kaliningrad Oblast, 236016, Russia
Municipal Healthcare Institution <>
Gatchina, Leningradskaya Oblast', 188300, Russia
Federal State Institution
Saratov, Saratov Oblast, 410028, Russia
City Healthcare Institution Clinical Hospital #8
Yaroslavl, Yaroslavl Oblast, 150030, Russia
Yaroslavl Regional Clinical Hospital
Yaroslavl, Yaroslavl Oblast, 150068, Russia
Altay State Medical University of federal agency of public health and social progress RF
Barnaul, 656038, Russia
Municipal Health Care Institution "City Hospital #1"
Barnaul, 656099, Russia
Kemerovo Cadiologiy Dispensary, Kemerovo Medical Academy
Kemerovo, 650002, Russia
Nonstate Healthcare Institution
Kemerovo, 650036, Russia
State Healthcare Institution "Region Clinical Hospital #1
Krasnodar, 350086, Russia
National Research Center for Preventitive Medicine
Moscow, 101990, Russia
Russian State Medical University, Hospital Therapy Department #1
Moscow, 111539, Russia
State Education High Professional Education Russian State Medical University
Moscow, 115093, Russia
Federal State Institution "Outpatient clinic #3 of President's Management Department of Russian Fede
Moscow, 129090, Russia
Research Institute of Physico-Chemical Medicine Center for Atheosclerosis and Laboratory
Moscow, 777020, Russia
Non State Health Care Institution Central Hospital #6 of Russian Railways JSC
Moscow, Russia
Novosibirsk Municipal Clinical Emergency Hosp. # 2
Novosibirsk, 630008, Russia
Almasov research institute of Cardiology
Saint Petersberg, 194156, Russia
Public Institution of Health City Hospital # 28
Saint Petersburg, 190000, Russia
State Institution Saint-Petersburg Dzhanelidze Scientific
Saint Petersburg, 192242, Russia
Saint-Petersburg State Healthcare Institution "City Alexander's Hospital"
Saint Petersburg, 193312, Russia
Saint-Petersburg Clinical Hospital of RAMS, policlinic department
Saint Petersburg, 194017, Russia
Federal State Health Care Institution
Saint Petersburg, 194291, Russia
Saint-Petersburg State Health Care Institution "City Hospital of Saint George the Martyr"
Saint Petersburg, 194354, Russia
Non-state Health Care Institution
Saint Petersburg, 195221, Russia
City Hospital #26
Saint Petersburg, 196247, Russia
City Hospital No 26
Saint Petersburg, 196247, Russia
Chair and Department of Hospital Therapy
Saint Petersburg, 197089, Russia
Medico- Military Academy, Navy Therapy Dept
Saint Petersburg, 198013, Russia
Saint-Petersburg State Institution of Health Protection, "City Hosptial # 15"
Saint Petersburg, 198205, Russia
Saint-Petersburg State Health Institution "Pokrovskaya City Hospital"
Saint Petersburg, 199106, Russia
Chair of Nephrology and Dialysis of St Petersburg State Medical University
Saint Petersburg, Russia
State Educational Institution of High Professional Education Saratov State Medical University
Saratov, 410054, Russia
State Institition Research Institution of Cardiology of Tomsk
Tomsk, 634012, Russia
State Educational institution of Higher Professional Education "Volgograd State Medical University o
Volgograd, 400001, Russia
State Health Care Institution "Voronezh Regional Clinical Consultative & Diagnostic Centre"
Voronezh, 396018, Russia
Related Publications (75)
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.
PMID: 22137068BACKGROUNDShah 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.
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PMID: 24249049RESULTPitt 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.
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PMID: 31214914DERIVEDKristensen SL, Mogensen UM, Jhund PS, Rorth R, Anand IS, Carson PE, Desai AS, Pitt B, Pfeffer MA, Solomon SD, Zile MR, Kober L, McMurray JJV. N-Terminal Pro-B-Type Natriuretic Peptide Levels for Risk Prediction in Patients With Heart Failure and Preserved Ejection Fraction According to Atrial Fibrillation Status. Circ Heart Fail. 2019 Mar;12(3):e005766. doi: 10.1161/CIRCHEARTFAILURE.118.005766.
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PMID: 26475142DERIVEDSolomon SD, Claggett B, Lewis EF, Desai A, Anand I, Sweitzer NK, O'Meara E, Shah SJ, McKinlay S, Fleg JL, Sopko G, Pitt B, Pfeffer MA; TOPCAT Investigators. Influence of ejection fraction on outcomes and efficacy of spironolactone in patients with heart failure with preserved ejection fraction. Eur Heart J. 2016 Feb 1;37(5):455-62. doi: 10.1093/eurheartj/ehv464. Epub 2015 Sep 15.
PMID: 26374849DERIVEDShah AM, Claggett B, Sweitzer NK, Shah SJ, Anand IS, Liu L, Pitt B, Pfeffer MA, Solomon SD. Prognostic Importance of Impaired Systolic Function in Heart Failure With Preserved Ejection Fraction and the Impact of Spironolactone. Circulation. 2015 Aug 4;132(5):402-14. doi: 10.1161/CIRCULATIONAHA.115.015884. Epub 2015 Jun 30.
PMID: 26130119DERIVEDBorlaug BA, Lewis GD, McNulty SE, Semigran MJ, LeWinter M, Chen H, Lin G, Deswal A, Margulies KB, Redfield MM. Effects of sildenafil on ventricular and vascular function in heart failure with preserved ejection fraction. Circ Heart Fail. 2015 May;8(3):533-41. doi: 10.1161/CIRCHEARTFAILURE.114.001915. Epub 2015 Mar 17.
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PMID: 25648577DERIVEDMak GJ, Ledwidge MT, Watson CJ, Phelan DM, Dawkins IR, Murphy NF, Patle AK, Baugh JA, McDonald KM. Natural history of markers of collagen turnover in patients with early diastolic dysfunction and impact of eplerenone. J Am Coll Cardiol. 2009 Oct 27;54(18):1674-82. doi: 10.1016/j.jacc.2009.08.021.
PMID: 19850207DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brian Harty
- Organization
- New England Research Institutes
Study Officials
- PRINCIPAL INVESTIGATOR
Sonja M. McKinlay, PhD
New England Research Institutes, Inc.
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2004
First Posted
October 15, 2004
Study Start
August 1, 2006
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
March 2, 2015
Results First Posted
March 2, 2015
Record last verified: 2014-01