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Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training



Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training

For Condition: Heart Failure,Heart Diseases,Cardiovascular Diseases
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To determine the long-term safety and effectiveness of exercise training for congestive heart failure patients.
Details: 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:
Study Type:
  Interventional, Prevention
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: No eligibility criteria
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
EugeneWolfel,  ,  University of Colorado

Wake Forest University School of Medicine *Recruiting*
Winston Salem,  North Carolina,  27157
United States
Recruiting Brittney  Fray 336-716-6967

Emory University Hospital *Recruiting*
Atlanta,  Georgia,  30322
United States
Recruiting Gail  Snell 404-712-0531

VA Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20422
United States
Recruiting Cindi  Rauert 202-745-8000

University Health Network *Recruiting*
Toronto,  Ontario,  M5T 258
Canada
Recruiting Anne  Cymet 1-416-603-5800

Shands Hospital *Recruiting*
Gainesville,  Florida,  32610
United States
Recruiting Cynthia  Williams 352-392-6078

Morehouse School of Medicine *Recruiting*
Atlanta,  Georgia,  30310
United States
Recruiting Sunday  Nkemdiche 404-756-5051

Cardiac Centers of Louisiana, LLC *Recruiting*
Shreveport,  Louisiana,  71135
United States
Recruiting Carrie  Gaskin 318-795-4025

London Health Sciences Center *Recruiting*
London,  Ontario,  N6A 4G5
Canada
Recruiting Julie  Smith 1-519-667-6807

University of Pennsylvania *Recruiting*
Philadelphia,  Pennsylvania,  19104
United States
Recruiting Jen  Dekerlegand 215-662-7774

Columbia University Heart Failure Center *Recruiting*
Bronxville,  New York,  10708
United States
Recruiting Margaret  Jones 914-787-4327

Hamilton General Hospital *Recruiting*
Hamilton,  Ontario,  L8L 2X2
Canada
Recruiting Linda  Beare 1-905-527-4322

University of Alabama at Birmingham *Recruiting*
Birmingham,  Alabama,  35294
United States
Recruiting Meredith  Fitz-Gerald 205-975-8088

Mayo Clinic *Recruiting*
Jacksonville,  Florida,  32216
United States
Recruiting Barbara  Berg 904-953-7988

University of Calgary *Recruiting*
Calgary,  Alberta,  T2N 4N1
Canada
Recruiting Jane  Grant 1-403-220-8282

Boston University Medical Center *Recruiting*
Boston,  Massachusetts,  02118
United States
Recruiting Nancy  Lim 617-638-8060

North Suffolk Cardiology Associates, PC *Recruiting*
East Setauket,  New York,  11733
United States
Recruiting Carol  Cherwinski 631-941-2000

Washington University School of Medicine *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Heidi  Craddock 314-454-7422

University of Minnesota *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Judith  Graziano 612-624-8427

University Hospitals of Cleveland *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting Marianne  Vest 216-844-2568

University of Louisville *Recruiting*
Louisville,  Kentucky,  40292
United States
Recruiting John  Manire 502-852-3068

LDS Hospital *Recruiting*
Salt Lake City,  Utah,  84143
United States
Recruiting Johnny  Walker 801-408-8618

University of Manitoba Health Sciences Center *Recruiting*
Winnipeg,  Manitoba,  R2H2A6
Canada
Recruiting Estrellita  Estrella-Holder 1-204-235-3149

Medical College of Ohio *Recruiting*
Toledo,  Ohio,  43614-2598
United States
Recruiting Holly  Burtch 419-383-3853

Laval Hospital *Recruiting*
Sainte-Foy,  Quebec,  G1V 4G5
Canada
Recruiting Rachel  Vienneau 1-418-656-8711

Hartford Hospital *Recruiting*
Hartford,  Connecticut,  06102
United States
Recruiting Cherie  Bilbie 860-545-1558

University of Colorado Health Sciences Center *Recruiting*
Denver,  Colorado,  80262
United States
Recruiting Mona  Cantu 303-372-0730

Medical City Hospital *Recruiting*
Dallas,  Texas,  75230
United States
Recruiting Natasha  Magee 972-566-6389

Davis Heart and Lung Research Institute *Recruiting*
Columbus,  Ohio,  43210
United States
Recruiting Joann  Homan 614-293-2908

Medical University of South Carolina *Recruiting*
Charleston,  South Carolina,  29403
United States
Recruiting Jenifer  Lake 843-876-5009

Queen Elizabeth II Health Sciences Center *Recruiting*
Halifax,  Nova Scotia,  B3K6A3
Canada
Recruiting Darlene  Cooley-Warnell 1-902-473-2728

Cleveland Clinic Foundatin *Recruiting*
Cleveland,  Ohio,  44195
United States
Recruiting Jay  Mudd 216-445-8203

Oregon Health & Sciences University *Recruiting*
Portland,  Oregon,  97239
United States
Recruiting Deirdre  Nauman 503-494-3957

Northwestern University Medical Center *Recruiting*
Chicago,  Illinois,  60611
United States
Recruiting Terry  Strzelczyk 312-926-1583

University of Medicine & Dentistry of New Jersey *Recruiting*
New Brunswick,  New Jersey,  08901
United States
Recruiting Nora  Cosgrove 732-235-6546

Cardiovascular Associates of Augusta *Recruiting*
Augusta,  Georgia,  30901
United States
Recruiting Shanda  Browning 706-724-2463

Ochsner Clinic Foundation *Recruiting*
New Orleans,  Louisiana,  70121
United States
Recruiting Bobbett  Harris 504-842-1134

University of North Carolina School of Medicine *Recruiting*
Chapel Hill,  North Carolina,  27599-7075
United States
Recruiting Val  Johnson 919-843-5212

University of Cincinnati *Recruiting*
Cincinnati,  Ohio,  45267-0542
United States
Recruiting Susan  Roll 513-558-6061

University of California at San Diego Medical Center *Recruiting*
San Diego,  California,  92103
United States
Recruiting Marcy  Sagerian 619-543-7723

Duke Medical Center *Recruiting*
Durham,  North Carolina,  27710
United States
Recruiting Brian  Duscha 919-660-6696

Saint Michaels Hospital *Recruiting*
Toronto,  Ontario,  M5B 1W8
Canada
Recruiting Darren  Day 1-416-864-6032

Saint John Hospital and Medical Center *Recruiting*
Detroit,  Michigan,  48236
United States
Recruiting Sharon  SKlar 313-343-4170

University of California Los Angeles *Recruiting*
Los Angeles,  California,  90095
United States
Recruiting Virginia  Erickson 310-825-8816

Cardiovascular Consultants *Recruiting*
Kansas City,  Missouri,  64111
United States
Recruiting Ann  Stewart 816-932-5396

University of Iowa Hospital and Clinics *Recruiting*
Iowa City,  Iowa,  52242-1081
United States
Recruiting Page  Scovel 319-384-8005

Oklahoma University Health Science Center *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Michelle  Thresher 405-271-2026

University of Wisconsin Madison *Recruiting*
Madison,  Wisconsin,  53792
United States
Recruiting Cassondra  Ark 608-265-0612

Beaumont Health Center *Recruiting*
Royal Oak,  Michigan,  48073
United States
Recruiting Kimberly  Dorrell 248-655-5865

Henry Ford Hospital *Recruiting*
Detroit,  Michigan,  48202
United States
Recruiting Matthew  Saval 313-972-4018


Additional Information:
Study ID Numbers:
  149; 
Study Start Date: September 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047437

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