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Heart Diseases |
Cardiac Arrest; Cardiac Diseases; Endocarditis; Heart Disease; Heart Disease and the Mind-Body Constitution; Heart Disease, Congenital; Heart Diseases (General); Heart Diseases--Prevention; Heart Infection, Endocarditis |
Clinical Trial: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training
This study is currently recruiting patients.
Purpose
To determine the long-term safety and effectiveness of exercise training for congestive heart failure patients.
| Condition | Treatment or Intervention |
|---|---|
| Cardiovascular Diseases Heart Diseases Heart Failure | Behavior: exercise |
MedlinePlus related topics: Cardiomyopathy; Heart Diseases; Heart Diseases--Prevention; Vascular Diseases
Study Type: Interventional
Study Design: Prevention
Further Study Details:
Study start: September 2002; Expected completion: July 2006
BACKGROUND: Congestive heart failure afflicts approximately five million Americans and is the number one cause of hospital admission in persons over the age of 65. Although exercise training improves several correlates of survival in patients with heart failure (e.g., peak VO2, heart rate variability, and plasma norepinephrine levels) it is not known whether exercise training reduces mortality in subjects with congestive heart failure.
DESIGN NARRATIVE: A multicenter randomized clinical trial to determine if exercise training reduces mortality and hospitalizations in persons with moderate to severe heart failure. The secondary objective is to evaluate to what extent an exercise program designed for heart failure patients improves quality of life and functioning, is economically advantageous, and avoids medical complications.
Heart failure afflicts approximately five million Americans and is the number one cause of hospital admission in persons over the age of 65. Although exercise training seems to improve health status as measured through several physiologic indicators, it is not known whether exercise training also reduces mortality and hospitalizations in persons with heart failure.
The trial plans to randomly assign 3,000 patients with moderate to severe heart failure to either standard medical therapy and education alone, or standard medical therapy and education plus a supervised exercise training program. The exercise training will include 36 supervised clinic-based training sessions followed by home-based exercise and periodic supervised sessions for reinforcement. Patients randomized to the training arm of the study will train by either treadmill or stationary bicycle. A treadmill or exercise bicycle will be provided to each training patient.
The trial will take place over 5 years, with an initial 6 months for planning, training, and implementation. Recruitment began in the Spring of 2003.
Eligibility
Genders Eligible for Study: Both
Criteria
No eligibility criteria
Location and Contact Information
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States; Recruiting
Meredith Fitz-Gerald, RN 205-975-8088 mfitzgerald@cardio.dom.uab.edu
Vera A. Bittner, Study Chair
Vera A. Bittner, Study Chair
California
University of California Los Angeles, Los Angeles, California, 90095, United States; Recruiting
Virginia Erickson, RN 310-825-8816 verickson@mednet.ucla.edu
Gregg C. Fonarow, Study Chair
Gregg C. Fonarow, Study Chair
University of California at San Diego Medical Center, San Diego, California, 92103, United States; Recruiting
Marcy Sagerian, RN 619-543-7723 msagerian@ucsd.edu
Denise Hermann, Principal Investigator
Denise Hermann, Principal Investigator
Colorado
University of Colorado Health Sciences Center, Denver, Colorado, 80262, United States; Recruiting
Mona Cantu, RN 303-372-0730 Mona.cantu@uchsc.edu
Eugene Wolfel, Study Chair
Eugene Wolfel, Study Chair
Connecticut
Hartford Hospital, Hartford, Connecticut, 06102, United States; Recruiting
Cherie Bilbie 860-545-1558 cbilbie@harthosp.org
Paul Thompson, Principal Investigator
Paul Thompson, Principal Investigator
District of Columbia
VA Medical Center, Washington, District of Columbia, 20422, United States; Recruiting
Cindi Rauert 202-745-8000 Cynthia.Rauert@med.va.gov
Peter Kokkinos, Principal Investigator
Peter Kokkinos, Principal Investigator
Florida
Shands Hospital, Gainesville, Florida, 32610, United States; Recruiting
Cynthia Williams, RN 352-392-6078 willicm@medicine.ufl.edu
James Hill, Principal Investigator
James Hill, Principal Investigator
Mayo Clinic, Jacksonville, Florida, 32216, United States; Recruiting
Barbara Berg 904-953-7988 berg.barbara2@mayo.edu
Gerald Fletcher, Principal Investigator
Gerald Fletcher, Principal Investigator
Georgia
Emory University Hospital, Atlanta, Georgia, 30322, United States; Recruiting
Gail Snell, RN 404-712-0531 gail_snell@emoryhealthcare.org
Andrew L. Smith, Study Chair
Andrew L. Smith, Study Chair
Cardiovascular Associates of Augusta, Augusta, Georgia, 30901, United States; Recruiting
Shanda Browning, RN 706-724-2463 shandabrowning@mindspring.com
A. Bleakley Chandler, Principal Investigator
A. Bleakley Chandler, Principal Investigator
Morehouse School of Medicine, Atlanta, Georgia, 30310, United States; Recruiting
Sunday Nkemdiche, MD 404-756-5051 snkemdic@msm.edu
Elizabeth Ofili, Principal Investigator
Elizabeth Ofili, Principal Investigator
Illinois
Northwestern University Medical Center, Chicago, Illinois, 60611, United States; Recruiting
Terry Strzelczyk, RN 312-926-1583 t-strzelczyk@northwestern.edu
Mihai Gheorghiade, Principal Investigator
Mihai Gheorghiade, Principal Investigator
Iowa
University of Iowa Hospital and Clinics, Iowa City, Iowa, 52242-1081, United States; Recruiting
Page Scovel, RN 319-384-8005 scovel@uiowa.edu
Ron Oren, Principal Investigator
Ron Oren, Principal Investigator
Kentucky
University of Louisville, Louisville, Kentucky, 40292, United States; Recruiting
John Manire 502-852-3068 jtmani01@athena.louisville.edu
Ann Swank, Principal Investigator
Ann Swank, Principal Investigator
Louisiana
Cardiac Centers of Louisiana, LLC, Shreveport, Louisiana, 71135, United States; Recruiting
Carrie Gaskin, RN 318-795-4025 cgaskin@arklatexcardio.net
Jalal Ghali, Principal Investigator
Jalal Ghali, Principal Investigator
Ochsner Clinic Foundation, New Orleans, Louisiana, 70121, United States; Recruiting
Bobbett Harris, RN 504-842-1134 bharris@ochsner.org
Mandeep Mehra, Principal Investigator
Mandeep Mehra, Principal Investigator
Massachusetts
Boston University Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Nancy Lim, RN 617-638-8060 nancy.zuech@bmc.org
Daniel E. Forman, Study Chair
Daniel E. Forman, Study Chair
Michigan
Henry Ford Hospital, Detroit, Michigan, 48202, United States; Recruiting
Matthew Saval 313-972-4018 msaval1@hfhs.org
Steven Keteyian, Study Chair
Steven Keteyian, Study Chair
Saint John Hospital and Medical Center, Detroit, Michigan, 48236, United States; Recruiting
Sharon SKlar, LPN 313-343-4170 sharon.sklar@stjohn.org
Julius Gardin, Principal Investigator
Julius Gardin, Principal Investigator
Beaumont Health Center, Royal Oak, Michigan, 48073, United States; Recruiting
Kimberly Dorrell 248-655-5865 kdorrell@smtpgw.beaumont.edu
Peter McCullough, Principal Investigator
Peter McCullough, Principal Investigator
Minnesota
University of Minnesota, Minneapolis, Minnesota, 55455, United States; Recruiting
Judith Graziano, RN, MS 612-624-8427 grazi005@umn.edu
Monica Colvin-Adams, Principal Investigator
Monica Colvin-Adams, Principal Investigator
Missouri
Washington University School of Medicine, St. Louis, Missouri, 63110, United States; Recruiting
Heidi Craddock, RN 314-454-7422 hcraddoc@im.wustl.edu
Gregory A. Ewald, Study Chair
Gregory A. Ewald, Study Chair
Cardiovascular Consultants, Kansas City, Missouri, 64111, United States; Recruiting
Ann Stewart, RN 816-932-5396 a1stewart@saint-lukes.org
Tracy Stevens, Principal Investigator
Tracy Stevens, Principal Investigator
New Jersey
University of Medicine & Dentistry of New Jersey, New Brunswick, New Jersey, 08901, United States; Recruiting
Nora Cosgrove, RN, CCRC 732-235-6546 cosgronm@umdnj.edu
John Kostis, Principal Investigator
John Kostis, Principal Investigator
New York
North Suffolk Cardiology Associates, PC, E. Setauket, New York, 11733, United States; Recruiting
Carol Cherwinski, RN 631-941-2000 cacherwinski@yahoo.com
John Reitano, Principal Investigator
John Reitano, Principal Investigator
Columbia University Heart Failure Center, Bronxville, New York, 10708, United States; Recruiting
Margaret Jones 914-787-4327 mj2019@columbia.edu
Susan Restaino, Principal Investigator
Susan Restaino, Principal Investigator
North Carolina
Wake Forest University School of Medicine, Winston Salem, North Carolina, 27157, United States; Recruiting
Brittney Fray 336-716-6967 bfray@wfubmc.edu
Dalane W. Kitzman, Study Chair
Dalane W. Kitzman, Study Chair
University of North Carolina School of Medicine, Chapel Hill, North Carolina, 27599-7075, United States; Recruiting
Val Johnson, RN 919-843-5212 vsjohns@med.unc.edu
Kirkwood Adams, Principal Investigator
Kirkwood Adams, Principal Investigator
Duke Medical Center, Durham, North Carolina, 27710, United States; Recruiting
Brian Duscha 919-660-6696 dusch001@mc.duke.edu
William Kraus, Principal Investigator
William Kraus, Principal Investigator
Ohio
Davis Heart and Lung Research Institute, Columbus, Ohio, 43210, United States; Recruiting
Joann Homan, RN 614-293-2908 homan.1@ohsu.edu
William T. Abraham, Study Chair
William T. Abraham, Study Chair
University Hospitals of Cleveland, Cleveland, Ohio, 44106, United States; Recruiting
Marianne Vest 216-844-2568 marianne.vest@uhhs.com
Ileana Pina, Study Chair
Ileana Pina, Study Chair
Cleveland Clinic Foundatin, Cleveland, Ohio, 44195, United States; Recruiting
Jay Mudd 216-445-8203 muddj@ccf.org
Gordon Blackburn, Principal Investigator
Gordon Blackburn, Principal Investigator
University of Cincinnati, Cincinnati, Ohio, 45267-0542, United States; Recruiting
Susan Kay Roll, RN 513-558-6061 rollsn@ucmail.uc.edu
Lynne Wagoner, Principal Investigator
Lynne Wagoner, Principal Investigator
Medical College of Ohio, Toledo, Ohio, 43614-2598, United States; Recruiting
Holly Burtch, RN 419-383-3853 hburtch@mco.edu
Dalynn Badenhop, Principal Investigator
Dalynn Badenhop, Principal Investigator
Oklahoma
Tulsa, Oklahoma, 74136, United States; Recruiting
Donna Smith, RN 1-918-502-4776 dokthor@aol.com
J. Frederick McNeer, Principal Investigator
J. Frederick McNeer, Principal Investigator
Oklahoma University Health Science Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Michelle Thresher 405-271-2026 tthreshe@ouhsc.edu
Udho Thadani, Principal Investigator
Udho Thadani, Principal Investigator
Oregon
Oregon Health & Sciences University, Portland, Oregon, 97239, United States; Recruiting
Deirdre Nauman, RN 503-494-3957 nauman@ohsu.edu
Ray E. Hershberger, Study Chair
Ray E. Hershberger, Study Chair
Pennsylvania
University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Jen Dekerlegand 215-662-7774 jennifer.torkish@uphs.upenn.edu
Andrew Kao, Principal Investigator
Andrew Kao, Principal Investigator
South Carolina
Medical University of South Carolina, Charleston, South Carolina, 29403, United States; Recruiting
Jenifer Lake 843-876-5009 lakejl@musc.edu
MIchael Zile, Principal Investigator
MIchael Zile, Principal Investigator
Texas
Medical City Hospital, Dallas, Texas, 75230, United States; Recruiting
Natasha Magee, RN 972-566-6389 Nmagee@CRSTI.org
Eric Eichhorn, Principal Investigator
Eric Eichhorn, Principal Investigator
Utah
LDS Hospital, Salt Lake City, Utah, 84143, United States; Recruiting
Johnny Walker 801-408-8618 ldjwalk2@ihc.com
Frank Yanowitz, Principal Investigator
Frank Yanowitz, Principal Investigator
Wisconsin
University of Wisconsin Madison, Madison, Wisconsin, 53792, United States; Recruiting
Cassondra Vander Ark 608-265-0612 cav@clinicaltrials.wisc.edu
Maryl Johnson, Principal Investigator
Maryl Johnson, Principal Investigator
Canada, Alberta
University of Calgary, Calgary, Alberta, T2N 4N1, Canada; Recruiting
Jane Grant, RN 1-403-220-8282 jgrant@ucalgary.ca
Debra Isaac, Principal Investigator
Debra Isaac, Principal Investigator
Canada, Manitoba
University of Manitoba Health Sciences Center, Winnipeg, Manitoba, R2H2A6, Canada; Recruiting
Estrellita Estrella-Holder, RN 1-204-235-3149 eestrell@sbgh.mb.ca
Eduardo Azevedo, Principal Investigator
Eduardo Azevedo, Principal Investigator
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, B3K6A3, Canada; Recruiting
Darlene Cooley-Warnell 1-902-473-2728 Darlene.warnell@cdha.nsheath.ca
Jonathan Howlett, Principal Investigator
Jonathan Howlett, Principal Investigator
Canada, Ontario
London Health Sciences Center, London, Ontario, N6A 4G5, Canada; Recruiting
Julie K. Smith, RN 1-519-667-6807 juliek.smith@lhsc.on.ca
Malcolm Arnold, Principal Investigator
Malcolm Arnold, Principal Investigator
Hamilton General Hospital, Hamilton, Ontario, L8L 2X2, Canada; Recruiting
Linda Beare 1-905-527-4322 beare@hhsc.ca
Robert McKelvie, Principal Investigator
Robert McKelvie, Principal Investigator
Saint Michaels Hospital, Toronto, Ontario, M5B 1W8, Canada; Recruiting
Darren Day 1-416-864-6032 dayd@smh.toronto.on.ca
Gordon Moe, Principal Investigator
Gordon Moe, Principal Investigator
University Health Network, Toronto, Ontario, M5T 258, Canada; Recruiting
Anne Cymet, RN 1-416-603-5800 anne.cymet@uhn.on.ca
Kenneth Melvin, Principal Investigator
Kenneth Melvin, Principal Investigator
Canada, Quebec
Laval Hospital, Sainte-Foy, Quebec, G1V 4G5, Canada; Recruiting
Rachel Vienneau, RN 1-418-656-8711 rachel.vienneau@crhl.ulaval.ca
Marie-Helene LeBlanc, Principal Investigator
Marie-Helene LeBlanc, Principal Investigator
Study chairs or principal investigators
William Abraham, Davis Heart and Lung Research Institute
Vera Bittner, University of Alabama, Birmingham
Gregory Ewald, Washington University School of Medicine
Gregg Fonarow, University of California, Los Angeles
Daniel Forman, Boston University Medical Center
Ray Hershberger, Oregon Health and Science University
Steven Keteyian, Henry Ford Hospital
Dalane Kitzman, Wake Forest University
Christopher O'Connor, Duke University
Ileana Pina, University Hospitals of Cleveland
Kevin Schulman, Duke University
Andrew Smith, Emory University Hospital
Eugene Wolfel, University of Colorado
More Information
Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training
Study ID Numbers: 149
Record last reviewed: March 2005
Last Updated: April 1, 2005
Record first received: October 3, 2002
ClinicalTrials.gov Identifier: NCT00047437
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: March 2005
Last Updated: April 1, 2005
Record first received: October 3, 2002
ClinicalTrials.gov Identifier: NCT00047437
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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