REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
NCT ID: NCT00271154
Last Updated: 2012-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
684 participants
INTERVENTIONAL
2004-09-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CRT OFF
Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
All randomized patients will be implanted with a market-released Medtronic CRT or CRT/ICD device.
CRT ON
Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
All randomized patients will be implanted with a market-released Medtronic CRT or CRT/ICD device.
Interventions
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Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
All randomized patients will be implanted with a market-released Medtronic CRT or CRT/ICD device.
Eligibility Criteria
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Inclusion Criteria
* Subjects with a QRS of 120 ms or more (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels/conducts through the ventricles. A wide QRS (120 ms or more) suggests that there is a conduction problem (or block) in the ventricles).
* Subjects with a left ventricular ejection fraction less than or equal to 40%. (The left ventricular ejection fraction (LVEF) is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the LVEF the more blood the ventricle is pumping.)
* Subjects with a left ventricular end diastolic dimension (LVEDD) greater than or equal to 55. (The left ventricular end diastolic dimension (LVEDD) is a measurement of heart size taken during an echocardiogram that is one indication of the health of the left ventricle.)
Exclusion Criteria
* Subjects with heart failure that severely limits daily activities (NYHA Class III) or subjects with severe heart failure with symptoms while resting (NYHA Class IV).
* Subjects hospitalized due to heart failure within past 3 months.
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Cecilia Linde, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden
Locations
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Huntsville, Alabama, United States
Anchorage, Alaska, United States
Redwood City, California, United States
San Diego, California, United States
Atlantis, Florida, United States
Jacksonville, Florida, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Ann Arbor, Michigan, United States
Saginaw, Michigan, United States
Coon Rapids, Minnesota, United States
Tupelo, Mississippi, United States
Lincoln, Nebraska, United States
East Syracuse, New York, United States
Manhasset, New York, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Marion, Ohio, United States
Doylestown, Pennsylvania, United States
Hershey, Pennsylvania, United States
West Reading, Pennsylvania, United States
Charleston, South Carolina, United States
Germantown, Tennessee, United States
Kingsport, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Madison, Wisconsin, United States
Sankt Pölten, , Austria
Weiner Neustadt, , Austria
Leuven, , Belgium
Kingston, Ontario, Canada
Brno, , Czechia
Olomouc, , Czechia
Aalborg, , Denmark
Aarhus, , Denmark
Copenhagen, , Denmark
Odense, , Denmark
Lyon, , France
Marseille, , France
Montpellier, , France
Nantes, , France
Rennes, , France
Bochum, , Germany
Hamburg, , Germany
Hanover, , Germany
Budapest, , Hungary
Szeged, , Hungary
Dublin, , Ireland
Busto Arsizio, , Italy
Florence, , Italy
Milan, , Italy
Rome, , Italy
Kristiansand, , Norway
Madrid, , Spain
Valencia, , Spain
Linköping, , Sweden
Stockholm, , Sweden
Blackpool, , United Kingdom
Countries
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References
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Linde C, Abraham WT, Gold MR, St John Sutton M, Ghio S, Daubert C; REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol. 2008 Dec 2;52(23):1834-1843. doi: 10.1016/j.jacc.2008.08.027. Epub 2008 Nov 7.
Linde C, Gold M, Abraham WT, Daubert JC; REVERSE Study Group. Baseline characteristics of patients randomized in The Resynchronization Reverses Remodeling In Systolic Left Ventricular Dysfunction (REVERSE) study. Congest Heart Fail. 2008 Mar-Apr;14(2):66-74. doi: 10.1111/j.1751-7133.2008.07613.x.
Gold MR, Abraham WT, Butler J, Zile MR, Kahwash R, Gerritse B, Linde C. Win ratio analysis of the REVERSE cardiac resynchronization trial. Heart Rhythm. 2025 May 3:S1547-5271(25)02407-5. doi: 10.1016/j.hrthm.2025.04.059. Online ahead of print.
Fudim M, Dalgaard F, Friedman DJ, Abraham WT, Cleland JGF, Curtis AB, Gold MR, Kutyifa V, Linde C, Ali-Ahmed F, Tang A, Olivas-Martinez A, Inoue LYT, Al-Khatib SM, Sanders GD. Comorbidities and clinical response to cardiac resynchronization therapy: Patient-level meta-analysis from eight clinical trials. Eur J Heart Fail. 2024 Apr;26(4):1039-1046. doi: 10.1002/ejhf.3029. Epub 2023 Sep 15.
Friedman DJ, Al-Khatib SM, Dalgaard F, Fudim M, Abraham WT, Cleland JGF, Curtis AB, Gold MR, Kutyifa V, Linde C, Tang AS, Ali-Ahmed F, Olivas-Martinez A, Inoue LYT, Sanders GD. Cardiac Resynchronization Therapy Improves Outcomes in Patients With Intraventricular Conduction Delay But Not Right Bundle Branch Block: A Patient-Level Meta-Analysis of Randomized Controlled Trials. Circulation. 2023 Mar 7;147(10):812-823. doi: 10.1161/CIRCULATIONAHA.122.062124. Epub 2023 Jan 26.
Gold MR, Rickard J, Daubert JC, Cerkvenik J, Linde C. Association of left ventricular remodeling with cardiac resynchronization therapy outcomes. Heart Rhythm. 2023 Feb;20(2):173-180. doi: 10.1016/j.hrthm.2022.11.016. Epub 2022 Nov 25.
Gold MR, Rickard J, Daubert JC, Zimmerman P, Linde C. Redefining the Classifications of Response to Cardiac Resynchronization Therapy: Results From the REVERSE Study. JACC Clin Electrophysiol. 2021 Jul;7(7):871-880. doi: 10.1016/j.jacep.2020.11.010. Epub 2021 Feb 24.
Senfield J, Daubert C, Abraham WT, Ghio S, St John Sutton M, Cerkvenik J, Linde C, Gold MR. The Impact of the PR Interval in Patients Receiving Cardiac Resynchronization Therapy: Results From the REVERSE Study. JACC Clin Electrophysiol. 2017 Aug;3(8):818-826. doi: 10.1016/j.jacep.2017.01.017. Epub 2017 Apr 26.
Linde C, Cleland JGF, Gold MR, Claude Daubert J, Tang ASL, Young JB, Sherfesee L, Abraham WT. The interaction of sex, height, and QRS duration on the effects of cardiac resynchronization therapy on morbidity and mortality: an individual-patient data meta-analysis. Eur J Heart Fail. 2018 Apr;20(4):780-791. doi: 10.1002/ejhf.1133. Epub 2018 Jan 4.
Gold MR, Padhiar A, Mealing S, Sidhu MK, Tsintzos SI, Abraham WT. Economic Value and Cost-Effectiveness of Cardiac Resynchronization Therapy Among Patients With Mild Heart Failure: Projections From the REVERSE Long-Term Follow-Up. JACC Heart Fail. 2017 Mar;5(3):204-212. doi: 10.1016/j.jchf.2016.10.014. Epub 2017 Jan 11.
St John Sutton M, Linde C, Gold MR, Abraham WT, Ghio S, Cerkvenik J, Daubert JC; REVERSE Study Group. Left Ventricular Architecture, Long-Term Reverse Remodeling, and Clinical Outcome in Mild Heart Failure With Cardiac Resynchronization: Results From the REVERSE Trial. JACC Heart Fail. 2017 Mar;5(3):169-178. doi: 10.1016/j.jchf.2016.11.012.
St John Sutton M, Cerkvenik J, Borlaug BA, Daubert C, Gold MR, Ghio S, Chirinos JA, Linde C, Ky B. Effects of Cardiac Resynchronization Therapy on Cardiac Remodeling and Contractile Function: Results From Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE). J Am Heart Assoc. 2015 Sep 11;4(9):e002054. doi: 10.1161/JAHA.115.002054.
Gold MR, Daubert JC, Abraham WT, Hassager C, Dinerman JL, Hudnall JH, Cerkvenik J, Linde C. Implantable defibrillators improve survival in patients with mildly symptomatic heart failure receiving cardiac resynchronization therapy: analysis of the long-term follow-up of remodeling in systolic left ventricular dysfunction (REVERSE). Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1163-8. doi: 10.1161/CIRCEP.113.000570. Epub 2013 Oct 14.
Linde C, Daubert C, Abraham WT, St John Sutton M, Ghio S, Hassager C, Herre JM, Bergemann TL, Gold MR; REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) Study Group. Impact of ejection fraction on the clinical response to cardiac resynchronization therapy in mild heart failure. Circ Heart Fail. 2013 Nov;6(6):1180-9. doi: 10.1161/CIRCHEARTFAILURE.113.000326. Epub 2013 Sep 6.
Cleland JG, Abraham WT, Linde C, Gold MR, Young JB, Claude Daubert J, Sherfesee L, Wells GA, Tang AS. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J. 2013 Dec;34(46):3547-56. doi: 10.1093/eurheartj/eht290. Epub 2013 Jul 29.
Linde C, Gold MR, Abraham WT, St John Sutton M, Ghio S, Cerkvenik J, Daubert C; REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction Study Group. Long-term impact of cardiac resynchronization therapy in mild heart failure: 5-year results from the REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) study. Eur Heart J. 2013 Sep;34(33):2592-9. doi: 10.1093/eurheartj/eht160. Epub 2013 May 2.
Gold MR, Thebault C, Linde C, Abraham WT, Gerritse B, Ghio S, St John Sutton M, Daubert JC. Effect of QRS duration and morphology on cardiac resynchronization therapy outcomes in mild heart failure: results from the Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) study. Circulation. 2012 Aug 14;126(7):822-9. doi: 10.1161/CIRCULATIONAHA.112.097709. Epub 2012 Jul 10.
Thebault C, Donal E, Meunier C, Gervais R, Gerritse B, Gold MR, Abraham WT, Linde C, Daubert JC; REVERSE study group. Sites of left and right ventricular lead implantation and response to cardiac resynchronization therapy observations from the REVERSE trial. Eur Heart J. 2012 Nov;33(21):2662-71. doi: 10.1093/eurheartj/ehr505. Epub 2012 Jan 26.
Gold MR, Linde C, Abraham WT, Gardiwal A, Daubert JC. The impact of cardiac resynchronization therapy on the incidence of ventricular arrhythmias in mild heart failure. Heart Rhythm. 2011 May;8(5):679-84. doi: 10.1016/j.hrthm.2010.12.031. Epub 2010 Dec 23.
Linde C, Abraham WT, Gold MR, Daubert C; REVERSE Study Group. Cardiac resynchronization therapy in asymptomatic or mildly symptomatic heart failure patients in relation to etiology: results from the REVERSE (REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction) study. J Am Coll Cardiol. 2010 Nov 23;56(22):1826-31. doi: 10.1016/j.jacc.2010.05.055.
Linde C, Daubert C. Cardiac resynchronization therapy in patients with New York Heart Association class I and II heart failure: an approach to 2010. Circulation. 2010 Sep 7;122(10):1037-43. doi: 10.1161/CIRCULATIONAHA.109.923094. No abstract available.
St John Sutton M, Ghio S, Plappert T, Tavazzi L, Scelsi L, Daubert C, Abraham WT, Gold MR, Hassager C, Herre JM, Linde C; REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) Study Group. Cardiac resynchronization induces major structural and functional reverse remodeling in patients with New York Heart Association class I/II heart failure. Circulation. 2009 Nov 10;120(19):1858-65. doi: 10.1161/CIRCULATIONAHA.108.818724. Epub 2009 Oct 26.
Daubert C, Gold MR, Abraham WT, Ghio S, Hassager C, Goode G, Szili-Torok T, Linde C; REVERSE Study Group. Prevention of disease progression by cardiac resynchronization therapy in patients with asymptomatic or mildly symptomatic left ventricular dysfunction: insights from the European cohort of the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) trial. J Am Coll Cardiol. 2009 Nov 10;54(20):1837-46. doi: 10.1016/j.jacc.2009.08.011. Epub 2009 Oct 1.
Other Identifiers
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233
Identifier Type: -
Identifier Source: org_study_id
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