Document Detail


Safety of symptom-limited cardiopulmonary exercise testing in patients with chronic heart failure due to severe left ventricular systolic dysfunction.
MedLine Citation:
PMID:  19782792     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: To assess the safety of symptom-limited exercise testing in patients with New York Heart Association class II-IV heart failure symptoms due to left ventricular systolic dysfunction, we investigated the frequency of all-cause fatal and nonfatal major cardiovascular (CV) events among subjects enrolled in a prospective clinical trial (HF-ACTION). We hypothesized that exercise testing would be safe, as defined by a rate for all-cause death of <0.1 per 1,000 tests and a rate of nonfatal CV events <1.0 per 1,000 tests.
METHODS: Before enrollment and at 3, 12, and 24 months after randomization, subjects were scheduled to complete a symptom-limited graded exercise test with open-circuit spirometry for analysis of expired gases. To ensure the accurate reporting of exercise test-related events, we report deaths and nonfatal major CV events per 1,000 tests at months 3, 12, or 24 after randomization.
RESULTS: A total of 2,331 subjects were randomized into HF-ACTION. After randomization, 2,037 subjects completed 4,411 exercise tests. There were no test-related deaths, exacerbation of heart failure or angina requiring hospitalization, myocardial infarctions, strokes, or transient ischemic attacks. There was one episode each of ventricular fibrillation and sustained ventricular tachycardia. There were no exercise test-related implantable cardioverter defibrillator discharges requiring hospitalization. These findings correspond to zero deaths per 1,000 exercise tests and 0.45 nonfatal major CV events per 1,000 exercise tests (95% CI 0.11-1.81).
CONCLUSIONS: In New York Heart Association class II-IV patients with severe left ventricular systolic dysfunction, we observed that symptom-limited exercise testing is safe based on no deaths and a rate of nonfatal major CV events that is <0.5 per 1,000 tests.
Authors:
Steven J Keteyian; Debra Isaac; Udho Thadani; Brad A Roy; Daniel R Bensimhon; Robert McKelvie; Stuart D Russell; Anne S Hellkamp; William E Kraus;
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  American heart journal     Volume:  158     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2009 Oct 
Date Detail:
Created Date:  2009-09-28     Completed Date:  2009-10-29     Revised Date:  2013-05-31    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  S72-7     Citation Subset:  AIM; IM    
Affiliation:
Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, MI, USA. sketeyi1@hfhs.org
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00047437
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MeSH Terms
Descriptor/Qualifier:
Aged
Angiotensin II Type 1 Receptor Blockers / therapeutic use
Chronic Disease
Exercise Test / adverse effects*,  methods,  statistics & numerical data
Female
Heart Failure / diagnosis*,  drug therapy,  physiopathology
Humans
Male
Middle Aged
Prognosis
Quality of Life
Safety / statistics & numerical data*
Severity of Illness Index
Stroke Volume / physiology
Ventricular Dysfunction, Left / diagnosis*,  drug therapy,  physiopathology
Grant Support
ID/Acronym/Agency:
R37 AG018915/AG/NIA NIH HHS; U01 HL064250-01A2/HL/NHLBI NIH HHS; U01 HL064250-02/HL/NHLBI NIH HHS; U01 HL064250-03/HL/NHLBI NIH HHS; U01 HL064250-04/HL/NHLBI NIH HHS; U01 HL064250-05/HL/NHLBI NIH HHS; U01 HL064250-06/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Angiotensin II Type 1 Receptor Blockers
Investigator
Investigator/Affiliation:
Christopher M O'Connor / ; Kerry L Lee / ; Stephen J Ellis / ; David S Rendall / ; David J Whellan / ; Ileana L Piña / ; Steven J Keteyian / ; Lawton S Cooper / ; Robin Boineau / ; Lawrence J Fine / ; Jerome L Fleg / ; Eric S Leifer / ; Virginia Erickson / ; Jonathan G Howlett / ; Nancy Houston Miller / ; Debra Isaac / ; Robert McKelvie / ; Faiez Zannad / ; Sharon Boozer / ; Patty Connolly / ; Anthony Doll / ; Stephen J Ellis / ; Camille Frazier / ; Deb Mark / ; Michelle McClanahan-Crowder / ; Marcia Meyer / ; Brenda S Mickley / ; David S Rendall / ; Molly Rich / ; Hoss Rostami / ; Sharon Settles / ; Kathy Spinella / ; Jessica Staib / ; Omar Thompson / ; William Abraham / ; Danuta Biniakiewicz / ; Joann Homan / ; Vera Bittner / ; Meredith Fitz-Gerald / ; Gregory Ewald / ; Heidi Craddock / ; Jean Flanagan / ; Gregg Fonarow / ; Virginia Erickson / ; Wilson Colucci / ; Nancy Z Lim / ; Elena Tokareva / ; Rami Alharethi / ; Ray Hershberger / ; Deirdre Nauman / ; Steven J Keteyian / ; Matthew Saval / ; Dalane W Kitzman / ; Brittney L Fray / ; Brian Moore / ; Ileana L Piña / ; Marianne Vest / ; Andrew Smith / ; Gail Snell / ; Eugene Wolfel / ; Mona Cantu / ; Kirkwood Adams / ; Jana Glotzer / ; Valerie Johnson / ; Kate Schumacher / ; Gordon Blackburn / ; Carrie Geither / ; Susan Moore / ; A Bleakley Chandler / ; Shanda Browning Vaughn / ; Paula J Easler / ; Debbie Williams / ; Marc Colmer / ; Julius M Gardin / ; Kelly Dimick / ; Sharon K Sklar / ; Sherri Teller / ; Jalal K Ghali / ; Karen Hale-Stenson / ; Mihai Gheorghiade / ; Theresa Strzelczyk / ; Maryl R Johnson / ; Cassondra Vander Ark / ; Lee R Goldberg / ; Andrew Kao / ; Jennifer Dekerlegand / ; William E Kraus / ; Johanna Johnson / ; Brian D Duscha / ; Mandeep R Mehra / ; Hector Ventura / ; Bobbett Harris / ; Monica Colvin-Adams / ; Kathy Duderstadt / ; Karen Meyer / ; Melissa Steger / ; Barry Cabuay / ; Ron Oren / ; Page Scovel / ; Andrew Kao / ; Tracey Stevens / ; Karen Haffey / ; Christy Mandacina / ; Ann Stewart / ; Ann M Swank / ; John Manire / ; Paul D Thompson / ; Ludmila Cosio-Lima / ; Marie Lagasse / ; Tehmina Naz / ; Lynne Wagoner / ; Susan K Roll / ; Frank G Yanowitz / ; Johnny Walker / ; Adam Mueller / ; Peter McCullough / ; Cathy Coleman / ; Kimberly A Dorrell / ; Tamika Washington / ; Eileen Handberg / ; James A Hill / ; Jacqueline Bakos / ; Alice Boyette / ; Pamela Smith / ; Cynthia Williams / ; Dalynn Badenhop / ; Susan Schroeder / ; Kelly Walter / ; Peter Kokkinos / ; Elisse Collins / ; Lauren Korsak / ; Eric Eichhorn / ; Allison Leonard / ; Tina Worley / ; Gerald Fletcher / ; Phil Peasley / ; Pam Oldano / ; John Kostis / ; Nora M Cosgrove / ; Udho Thadani / ; Lisa Rogan / ; Michelle Thresher / ; John Turner / ; Denise Barnard / ; Denise Herman / ; Annette Contasti / ; Marcy Sagerian / ; Elizabeth Ofili / ; Anekwe Onwuanyi / ; Sunday Nkemdiche / ; Howard Eisen / ; James Fitzpatrick / ; Joyce Wald / ; Jennie Wong / ; Myrvin Ellestad / ; Leslie Kern / ; Ezra A Amsterdam / ; Mary J Burns / ; Savitri Fedson / ; Ravi K Garg / ; Peggy Bennett / ; Linda Bond / ; Leway Chen / ; Janice Schrack / ; Douglas Pearce / ; Linda Bond / ; Greg Palevo / ; Margarett Serfass / ; Daniel Forman / ; Maria M Lopez / ; Yemi Talabi-Oates / ; April Williams / ; David Truitte / ; Cindy Baumann / ; Jenny Adams / ; Anne Lawrence / ; Dennis McNamara / ; Emily Gruendler / ; Virginia Schneider / ; Steven Hutchins / ; Alyce Hartwick / ; Paul Campbell / ; Michele Esposito / ; Carol Buchter / ; Rebecca A Letterer / ; Robert Taylor / ; Cheri Wells / ; Bruce Johnson / ; Beth Kaping / ; Susan Leathes / ; Joseph O'Bryan / ; Lynn Langley / ; Edward T Hastings / ; Cassandra Clancy / ; Neil Agruss / ; Christine Lawless / ; Robin Fortman / ; Timothy R McConnell / ; Deb Wantz / ; Mary N Walsh / ; Regina Margiotti / ; Stuart Russell / ; Elizabeth Heck / ; Justine Lachmann / ; Diane Lippman / ; Jeannette McLaughlin / ; Joel Landzberg / ; Susan Mathus / ; David W Cullinane / ; Wyatt Voyles / ; Dione Lenz / ; Scott Kaczkowski / ; Jack L David / ; Eve Gillespie / ; Pat Keane-Richmond / ; Steven K Krueger / ; Lori Heiss / ; Stephen Gottlieb / ; Nancy Greenberg / ; Neil Gordon / ; Emily Parks / ; Melanie Willoughby / ; Marvin W Kronenberg / ; Jennie Glenn / ; Carol Madison / ; Malcolm Arnold / ; Julie K Smith / ; Eduardo Azevedo / ; Glen Drobot / ; Estrellita Estrella-Holder / ; Jonathan Howlett / ; Darlene Cooley-Warnell / ; Sheila Yarn / ; Debra Isaac / ; Jane Grant / ; Kim Lyzun / ; Marie-Helene LeBlanc / ; Rachel Vienneau / ; Robert S McKelvie / ; Linda Beare / ; Jill Hancock / ; Gordon Moe / ; Delores Golob / ; Kenneth Melvin / ; Anne Cymet / ; Judith Renton / ; Anil Nigam / ; Julie LaLonge / ; Karim Djaballah / ; Patrick Aebehard / ; Marie Christine Iliou / ; Remi Sabatier / ; Annette Belin / ; Alain Cohen-Solal / ; Luc Hittinger / ; Bertram Pitt / ; Philip A Ades / ; Lotfy L Basta / ; Victor Froelicher / ; Mary Elizabeth Hamel / ; Barry M Massie / ; Lemuel Moyé / ; Lynda H Powell / ; William E Kraus / ; Johanna Johnson / ; Lucy Piner / ; Daniel Bensimhon / ; Stuart Russell / ; Julius M Gardin / ; Renee L Bess / ; Gerald I Cohen / ; Steven J Keteyian / ; Jonathan K Ehrman / ; Clinton A Brawner / ; Nancy Houston Miller / ; James A Blumenthal / ; Krista Barbour / ; Tanya M Spruill / ; Bess Marcus / ; Jim Raczynski / ; Kirkwood Adams / ; Mark Donahue / ; Mike Felker / ; Kevin A Schulman / ; Kevin P Weinfurt / ; Kathryn E Flynn / ; Shelby Reed / ; Ann Burnette / ; Linda Davidson-Ray / ; Joëlle Y Friedman / ; Yanhong Li / ; Li Lin / ; Betsy O'Neal / ; Michael Zile / ; Ralph H Johnson / ; Daniel R Bensimhon / ; Vera Bittner / ; Robin Boineau / ; Mark E Dunlap / ; William E Kraus / ; Christopher M O'Connor / ; Gordon Moe / ; John Wertheimer / ; David J Whellan /
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