Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00047437
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 2,331
• Locations: 80
• Arms: 2
• Duration (Months): 63
• Patients Per Site: 29.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases; Heart Diseases; Heart Failure, Congestive	Behavioral: Supervised Exercise Training Program	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2331 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
• Study Start Date: Apr 1, 2003
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2	Behavioral: Supervised Exercise Training Program; Exercise 30 minutes minimum three times per week.
No Intervention: 1

Outcome Measures

Primary Outcome Measures

1. Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) [Measured as events occur during the lifespan of the trial.]

Secondary Outcome Measures

1. Changes in peak VO2 [Measured at 3 months, 12 months, and 24 months.]

2. Changes in VE/VCO2 slope [Measured at 3 months, 12 months, and 24 months.]

3. Heart rate at a submaximal work load defined as the end of the exercise test's second stage [Measured at 3 months, 12 months, and 24 months.]

4. Changes in 6-minute walk (measured at Month 3 and Year 1) [Measured at 3 months, 12 months, 24 months, 36 months, and at end of study.]

5. Composite of cardiovascular mortality and cardiovascular hospitalization rates [Measured as events occur during the life of the trial.]

6. Composite of cardiovascular mortality and CHF hospitalization rates [Measured as events occur during the life of the trial.]

7. All-cause mortality rates [Measured as events occur during the life of the trial.]

8. Cardiovascular mortality rates [Measured as events occur during the life of the trial.]

9. All-cause hospitalization rates [Measured as events occur during the life of the trial.]

10. CHF hospitalization rates [Measured as events occur during the life of the trial.]

11. Heart attack rates [Measured as events occur during the life of the trial.]

12. Worsening CHF event rates [Measured as events occur during the life of the trial.]

13. Composite of all-cause mortality, all-cause hospitalization, emergency room visit, and urgent clinic visit for CHF exacerbation rates [Measured as events occur during the life of the trial.]

14. Cost [Measured throughout the life of the trial.]

15. Quality of life [Measured at baseline, months 3, 6, 9, 12, 15, 18, 21, 24, 36, and end of study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Heart Clinic Arkansas	Little Rock	Arkansas	United States	72205
3	Memorial Heart Institute	Long Beach	California	United States	90806
4	Ahmanson-University of California Los Angeles	Los Angeles	California	United States	90095
5	University of California, Davis Medical Center	Sacramento	California	United States	95817
6	University of California at San Diego Medical Center	San Diego	California	United States	92103
7	University of Colorado Health Sciences Center	Denver	Colorado	United States	80262
8	Heart and Vascular Clinic of Northern Colorado	Fort Collins	Colorado	United States	80528
9	Hartford Hospital	Hartford	Connecticut	United States	06102-5037
10	Veterans Affairs Medical Center	Washington	District of Columbia	United States	20422
11	Southwest Florida Heart Group	Fort Myers	Florida	United States	33919
12	University of Florida	Gainesville	Florida	United States	32610
13	Mayo Clinic	Jacksonville	Florida	United States	32216
14	Morehouse School of Medicine	Atlanta	Georgia	United States	30310
15	Emory University Hospital	Atlanta	Georgia	United States	30322
16	Cardiovascular Associates of Augusta	Augusta	Georgia	United States	30901
17	Heart and Lung Group of Savannah	Savannah	Georgia	United States	31405
18	Northwestern University Medical Center	Chicago	Illinois	United States	60611
19	University of Chicago Hospitals	Chicago	Illinois	United States	60637
20	Central DuPage Hospital	Winfield	Illinois	United States	60190
21	The Care Group, LLC	Indianapolis	Indiana	United States	46260
22	University of Iowa Hospital and Clinics	Iowa City	Iowa	United States	52242-1081
23	University of Louisville	Louisville	Kentucky	United States	40292
24	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
25	University of Maryland	Baltimore	Maryland	United States	21201
26	Johns Hopkins University Medical Center	Baltimore	Maryland	United States	21287
27	Boston Medical Center	Boston	Massachusetts	United States	02118
28	Brigham and Women's Hospital	Boston	Massachusetts	United States	02120-1613
29	Henry Ford Hospital	Detroit	Michigan	United States	48202
30	Saint John Hospital and Medical Center	Detroit	Michigan	United States	48236
31	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
32	University of Minnesota	Minneapolis	Minnesota	United States	55455
33	Mayo Clinic	Rochester	Minnesota	United States	55905
34	Mid America Heart Institute-Saint Luke's Hospital	Kansas City	Missouri	United States	64111
35	Washington University School of Medicine	St. Louis	Missouri	United States	63110
36	Glacier View Cardiology, P.C.	Kalispell	Montana	United States	59901
37	Bryan Lincoln General Hospital	Lincoln	Nebraska	United States	68516
38	University of Medicine & Dentistry of New Jersey	New Brunswick	New Jersey	United States	08901
39	Hackensack University Medical Center	Westwood	New Jersey	United States	07601
40	University of New Mexico	Albuquerque	New Mexico	United States	87131-0001
41	University of Rochester	Rochester	New York	United States	14624
42	Saint Francis Hospital	Roslyn	New York	United States	11576
43	University of North Carolina School of Medicine	Chapel Hill	North Carolina	United States	17517
44	Northeast Medical Center	Concord	North Carolina	United States	28025
45	Duke University Medical Center	Durham	North Carolina	United States	27710
46	Wake Forest University School of Medicine	Winston-Salem	North Carolina	United States	27157
47	University of Cincinnati	Cincinnati	Ohio	United States	45267-0542
48	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
49	Davis Heart and Lung Research Institute	Columbus	Ohio	United States	43210-1252
50	Medical University of Ohio	Toledo	Ohio	United States	43614-2598
51	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
52	Oregon Health & Sciences University	Portland	Oregon	United States	97239
53	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
54	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
55	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
56	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
57	Saint Thomas Hospital	Nashville	Tennessee	United States	37205
58	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212
59	Medical City Dallas Hospital	Dallas	Texas	United States	75230
60	Baylor Heart and Vascular Hospital	Dallas	Texas	United States	75426
61	LDS Hospital	Salt Lake City	Utah	United States	84143
62	Lynchburg General Hospital	Lynchburg	Virginia	United States	24501
63	University of Washington Medical Center	Seattle	Washington	United States	98195-6310
64	University of Wisconsin Madison	Madison	Wisconsin	United States	53792
65	Aurora Health Care	Milwaukee	Wisconsin	United States	53215
66	University of Calgary	Calgary	Alberta	Canada	T2N 4N1
67	University of Manitoba Health Sciences Center	Winnipeg	Manitoba	Canada	R2H 2A6
68	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia	Canada	B3K6A3
69	Hamilton General Hospital	Hamilton	Ontario	Canada	L8L 2X2
70	London Health Sciences Center	London	Ontario	Canada	N6A 4G5
71	Saint Michaels Hospital	Toronto	Ontario	Canada	M5B 1W8
72	Toronto General Hospital	Toronto	Ontario	Canada	M5T 2S8
73	Montreal Heart Institute	Montreal	Quebec	Canada	H1T 1N6
74	Laval Hospital	Sainte Foy	Quebec	Canada	G1V 4G5
75	CHU de Caen	Caen		France	14000
76	Hopital Beaujon Cardiologie	Clichy		France	92110
77	Hopital Henri Mondor-Service de C	Creteil		France	94010
78	Hopital Broussais	Paris		France	75014
79	Centre Cardiologie du Nord	Saint Denis		France	93200
80	Hopital Brabois	Vandoeuvre Les Nancy		France	54500

Sponsors and Collaborators

• Duke University
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Study Chair: Christopher M. O'Connor, Duke University
• Study Chair: David J. Whellan, Jefferson Medical College of Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Whellan DJ, O'Connor CM, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Houston-Miller N, Fleg JL, Schulman KA, Piña IL; HF-ACTION Trial Investigators. Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. Am Heart J. 2007 Feb;153(2):201-11.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00047437
• Other Study ID Numbers: Pro00017406; U01HL063747; U01HL064250; U01HL064257; U01HL064264; U01HL064265; U01HL066461; U01HL066482; U01HL066491; U01HL066494; U01HL066497; U01HL066501; U01HL068973; U01HL068980
• First Posted: Oct 4, 2002
• Last Update Posted: Mar 21, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Heart Failure; Cardiovascular Diseases; Heart Diseases

Study Results

No Results Posted as of Mar 21, 2013