Trial record 1 of 1 for:
NCT00047437
Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure
This study has been completed.
Sponsor:
Duke University
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00047437
First received: October 3, 2002
Last updated: March 20, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Diseases Heart Diseases Heart Failure, Congestive |
Behavioral: Supervised Exercise Training Program |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) [ Time Frame: Measured as events occur during the lifespan of the trial. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Changes in peak VO2 [ Time Frame: Measured at 3 months, 12 months, and 24 months. ] [ Designated as safety issue: No ]
- Changes in VE/VCO2 slope [ Time Frame: Measured at 3 months, 12 months, and 24 months. ] [ Designated as safety issue: No ]
- Heart rate at a submaximal work load defined as the end of the exercise test's second stage [ Time Frame: Measured at 3 months, 12 months, and 24 months. ] [ Designated as safety issue: No ]
- Changes in 6-minute walk (measured at Month 3 and Year 1) [ Time Frame: Measured at 3 months, 12 months, 24 months, 36 months, and at end of study. ] [ Designated as safety issue: No ]
- Composite of cardiovascular mortality and cardiovascular hospitalization rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- Composite of cardiovascular mortality and CHF hospitalization rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- All-cause mortality rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- Cardiovascular mortality rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- All-cause hospitalization rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- CHF hospitalization rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- Heart attack rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- Worsening CHF event rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- Composite of all-cause mortality, all-cause hospitalization, emergency room visit, and urgent clinic visit for CHF exacerbation rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- Cost [ Time Frame: Measured throughout the life of the trial. ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Measured at baseline, months 3, 6, 9, 12, 15, 18, 21, 24, 36, and end of study ] [ Designated as safety issue: No ]
| Enrollment: | 2331 |
| Study Start Date: | April 2003 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 2 |
Behavioral: Supervised Exercise Training Program
Exercise 30 minutes minimum three times per week.
|
| No Intervention: 1 |
Detailed Description:
BACKGROUND:
CHF affects approximately five million Americans and is the number one cause of hospital admission in individuals over the age of 65. Although exercise training improves several clinical measures in individuals with CHF (e.g., peak VO2, heart rate variability, and plasma norepinephrine levels), it is not known whether exercise training reduces mortality in individuals with CHF.
DESIGN NARRATIVE:
This multicenter randomized study will determine if exercise training reduces mortality and hospitalization rates in individuals with moderate to severe CHF. The secondary objective is to evaluate whether an exercise program designed for individuals with CHF improves quality of life and functioning, is economically advantageous, and prevents medical complications.
Three thousand individuals with moderate to severe CHF will be randomly assigned to either standard medical therapy and education, 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. Participants assigned to the supervised exercise training program will use either a treadmill or stationary bicycle, which will be provided for them.
Recruitment Status: As of November 9, 2006, HF-ACTION has enrolled 2180 subjects and will conclude enrollment at the end of February, 2007, with an anticipated enrollment of approximately 2300 subjects.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- LVEF less than or equal to 35%
- New York Heart Association (NYHA) class II, III, or IV CHF diagnosis in the 3 months prior to study entry, with a minimum of 6 weeks of treatment
- Must be on optimal heart failure therapy according to American Heart Association (AHA), American College of Cardiology (ACC), and Heart Failure Society of America (HFSA) heart failure guidelines, including treatment with angiotensin II converting enzyme inhibitors (ACEI) and beta-blocker therapy, or have documentation justifying why optimal therapy is not being used, including intolerance, contraindication, participant preference, or physician's judgment
- Must be on stable doses of medications (e.g., beta-blocker, ACEI, and additional medications as listed in the study guidelines) for 6 weeks prior to study entry
- Must be in stable medical condition and able to begin an exercise program, as determined by study physician
Exclusion Criteria:
- Comorbid disease, behavioral limitations, or other limitations that would interfere with exercise training, or would prevent completion of 1 year of exercise training
- Pregnant or planning to become pregnant in the year following study entry
- Major heart event or heart procedure within the 6 weeks prior to study entry
- Heart procedure or hospitalization for any reason planned in the future
- Expecting to receive a heart transplant in the 6 months following study entry
- CHF caused by significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction); if valve replacement has been performed, may not participate for 12 months following the procedure
- CHF caused by congenital heart disease or obstructive cardiomyopathy
- Performance of exercise training at regular intervals (more than once per week) at a moderate to vigorous intensity at any time in the 6 weeks prior to study entry
- Exercise testing results that would prevent safe exercise training, as defined by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines, including abnormal blood pressure response, early ischemic changes, and unexpected life-threatening arrhythmia
- Use of fixed-rate pacemakers, pacemakers with inability to attain target heart rates, or automatic implantable cardioverter defibrillator (AICD) devices with heart rate limits set below the target heart rate for exercise training
- Use of an intracardiac device such as an implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy pacemaker in the 6 months prior to study entry (must demonstrate stability for 6 weeks post-procedure)
- Primary physician considers placement of an intracardiac device such as an ICD or a cardiac resynchronization therapy pacemaker probable within 6 months of study entry; will be excluded until such device has been placed and 6 weeks of stabilization have passed
- Participation in another clinical trial that may interfere with study participation, follow-up, or data collection, or that may affect cardiovascular morbidity or mortality
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047437
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| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arkansas | |
| Heart Clinic Arkansas | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Memorial Heart Institute | |
| Long Beach, California, United States, 90806 | |
| Ahmanson-University of California Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| University of California, Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| University of California at San Diego Medical Center | |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| Heart and Vascular Clinic of Northern Colorado | |
| Fort Collins, Colorado, United States, 80528 | |
| United States, Connecticut | |
| Hartford Hospital | |
| Hartford, Connecticut, United States, 06102-5037 | |
| United States, District of Columbia | |
| Veterans Affairs Medical Center | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Florida | |
| Southwest Florida Heart Group | |
| Fort Myers, Florida, United States, 33919 | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32216 | |
| United States, Georgia | |
| Emory University Hospital | |
| Atlanta, Georgia, United States, 30322 | |
| Morehouse School of Medicine | |
| Atlanta, Georgia, United States, 30310 | |
| Cardiovascular Associates of Augusta | |
| Augusta, Georgia, United States, 30901 | |
| Heart and Lung Group of Savannah | |
| Savannah, Georgia, United States, 31405 | |
| United States, Illinois | |
| Northwestern University Medical Center | |
| Chicago, Illinois, United States, 60611 | |
| University of Chicago Hospitals | |
| Chicago, Illinois, United States, 60637 | |
| Central DuPage Hospital | |
| Winfield, Illinois, United States, 60190 | |
| United States, Indiana | |
| The Care Group, LLC | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Iowa | |
| University of Iowa Hospital and Clinics | |
| Iowa City, Iowa, United States, 52242-1081 | |
| United States, Kentucky | |
| University of Louisville | |
| Louisville, Kentucky, United States, 40292 | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Johns Hopkins University Medical Center | |
| Baltimore, Maryland, United States, 21287 | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02120-1613 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Saint John Hospital and Medical Center | |
| Detroit, Michigan, United States, 48236 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Mid America Heart Institute-Saint Luke's Hospital | |
| Kansas City, Missouri, United States, 64111 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| Glacier View Cardiology, P.C. | |
| Kalispell, Montana, United States, 59901 | |
| United States, Nebraska | |
| Bryan Lincoln General Hospital | |
| Lincoln, Nebraska, United States, 68516 | |
| United States, New Jersey | |
| University of Medicine & Dentistry of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| Hackensack University Medical Center | |
| Westwood, New Jersey, United States, 07601 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131-0001 | |
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14624 | |
| Saint Francis Hospital | |
| Roslyn, New York, United States, 11576 | |
| United States, North Carolina | |
| University of North Carolina School of Medicine | |
| Chapel Hill, North Carolina, United States, 17517 | |
| Northeast Medical Center | |
| Concord, North Carolina, United States, 28025 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Wake Forest University School of Medicine | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267-0542 | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| Davis Heart and Lung Research Institute | |
| Columbus, Ohio, United States, 43210-1252 | |
| Medical University of Ohio | |
| Toledo, Ohio, United States, 43614-2598 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Oregon Health & Sciences University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Saint Thomas Hospital | |
| Nashville, Tennessee, United States, 37205 | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| Baylor Heart and Vascular Hospital | |
| Dallas, Texas, United States, 75426 | |
| United States, Utah | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| United States, Virginia | |
| Lynchburg General Hospital | |
| Lynchburg, Virginia, United States, 24501 | |
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6310 | |
| United States, Wisconsin | |
| University of Wisconsin Madison | |
| Madison, Wisconsin, United States, 53792 | |
| Aurora Health Care | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Canada, Alberta | |
| University of Calgary | |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Canada, Manitoba | |
| University of Manitoba Health Sciences Center | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Center | |
| Halifax, Nova Scotia, Canada, B3K6A3 | |
| Canada, Ontario | |
| Hamilton General Hospital | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| London Health Sciences Center | |
| London, Ontario, Canada, N6A 4G5 | |
| Saint Michaels Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Canada, Quebec | |
| Montreal Heart Institute | |
| Montreal, Quebec, Canada, H1T 1N6 | |
| Laval Hospital | |
| Sainte Foy, Quebec, Canada, G1V 4G5 | |
| France | |
| CHU de Caen | |
| Caen, France, 14000 | |
| Hopital Beaujon Cardiologie | |
| Clichy, France, 92110 | |
| Hopital Henri Mondor-Service de C | |
| Creteil, France, 94010 | |
| Hopital Broussais | |
| Paris, France, 75014 | |
| Centre Cardiologie du Nord | |
| Saint Denis, France, 93200 | |
| Hopital Brabois | |
| Vandoeuvre Les Nancy, France, 54500 | |
Sponsors and Collaborators
Duke University
Investigators
| Study Chair: | Christopher M. O'Connor | Duke University |
| Study Chair: | David J. Whellan | Jefferson Medical College of Thomas Jefferson University |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00047437 History of Changes |
| Other Study ID Numbers: | Pro00017406, U01HL063747, U01 HL64250, U01 HL64257, U01 HL64264, U01 HL64265, U01 HL66461, U01 HL66482, U01 HL66491, U01 HL66494, U01 HL66497, U01 HL66501, U01 HL68973, U01 HL68980 |
| Study First Received: | October 3, 2002 |
| Last Updated: | March 20, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Heart Diseases Heart Failure |
ClinicalTrials.gov processed this record on May 23, 2013