PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy

Predictors of Response to Cardiac Re-Synchronization Therapy

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. Using a medical device like a pacemaker or a defibrillator can help the heart to pump in regular beats. However, not all patients do better with a device. Currently, there is not a way to identify which patients will benefit from the device. The purpose of this study is to determine if using medical tests, Echocardiogram, can help in predicting which patients will improve. The types of patients needed for this study are those who have been diagnosed with moderate or severe heart failure.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Congestive Heart Failure; Cardiomyopathy

• Study Type: Observational
• Enrollment: 450

Contacts and Locations

Study Locations

• Austria
  • Several locations, Austria
• Belgium
  • Several locations, Belgium
• Denmark
  • Several locations, Denmark
• Finland
  • Several locations, Finland
• France
  • Several locations, France
• Germany
  • Several locations, Germany
• Hong Kong
  • Several locations, Hong Kong
• Italy
  • Several locations, Italy
• Netherlands
  • Several locations, Netherlands
• Norway
  • Several locations, Norway
• Spain
  • Several locations, Spain
• United Kingdom
  • Several locations, United Kingdom
• United States
  • California
    • Several locations, California, United States
  • Florida
    • Gainsville, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
  • Illinois
    • Columbus, Illinois, United States
  • Kansas
    • Kansas City, Kansas, United States
  • Louisiana
    • New Orleans, Louisiana, United States
  • Michigan
    • Grand Rapids, Michigan, United States
  • New Jersey
    • Several locations, New Jersey, United States
  • New York
    • Several locations, New York, United States
  • North Carolina
    • Winston-Salem, North Carolina, United States
  • Ohio
    • Several locations, Ohio, United States
  • Pennsylvania
    • Dolyestown, Pennsylvania, United States
  • Tennessee
    • Nashville, Tennessee, United States
  • Vermont
    • Burlington, Vermont, United States
  • Virginia
    • Norfolk, Virginia, United States
  • Washington
    • Seattle, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Moderate to severe heart failure

  • Ejection Fraction ( measurement of blood pumped out of the heart) less than 35%
  • Wide (greater than 130 milliseconds) QRS duration for US patients only.
  • May include patients with less than 130 millisecond QRS duration if they have mechanical dyssynochrony (uncoordinated heart contractions) in Europe.
  • All patients enrolled should be stable on medications that include at least an ACE inhibitor or Angiotensin Receptor Blocker (ARB) and at optimal level for at least one month prior to surgery

Exclusion Criteria:

• Patients that are not eligible for this study are those that have a mechanical right heart valve or are experiencing the following medical conditions within the last 3 months:

  • Chest pain / unstable angina
  • Acute heart attack
  • Chronic or permanent atrial arrhythmias such as atrial fibrillation
  • Contrary artery bypass graft (CABG)
  • Percutaneous transluminal coronary angioplasty (PTCA)
  • Patients who have had intermittent or continuous Inotropic drug therapy are not eligible for this study.
  • Patients who have had heart transplant or a prior Cardiac Resynchronization Therapy device are not eligible for this study.
  • Patients who are pregnant or are of child-bearing potential are not on a form of birth control may not participate in this study.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Collaborators: Medtronic
• Investigators: Principal Investigator: William T Abraham, MD, University of Ohio

Publications and helpful links

General Publications

• Hsing JM, Selzman KA, Leclercq C, Pires LA, McLaughlin MG, McRae SE, Peterson BJ, Zimetbaum PJ. Paced left ventricular QRS width and ECG parameters predict outcomes after cardiac resynchronization therapy: PROSPECT-ECG substudy. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):851-7. doi: 10.1161/CIRCEP.111.962605. Epub 2011 Sep 28.
• Chan PS, Khumri T, Chung ES, Ghio S, Reid KJ, Gerritse B, Nallamothu BK, Spertus JA. Echocardiographic dyssynchrony and health status outcomes from cardiac resynchronization therapy: insights from the PROSPECT trial. JACC Cardiovasc Imaging. 2010 May;3(5):451-60. doi: 10.1016/j.jcmg.2009.08.012.
• Chung ES, Leon AR, Tavazzi L, Sun JP, Nihoyannopoulos P, Merlino J, Abraham WT, Ghio S, Leclercq C, Bax JJ, Yu CM, Gorcsan J 3rd, St John Sutton M, De Sutter J, Murillo J. Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. 2008 May 20;117(20):2608-16. doi: 10.1161/CIRCULATIONAHA.107.743120. Epub 2008 May 5.

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: November 13, 2005
• First Submitted That Met QC Criteria: November 14, 2005
• First Posted (Estimate): November 15, 2005

Study Record Updates

• Last Update Posted (Estimate): December 21, 2007
• Last Update Submitted That Met QC Criteria: December 17, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Heart Failure; Defibrillator; Fluid overload; Congestive Heart Failure; Pacemaker; Left sided heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Cardiomyopathies
• Other Study ID Numbers: 226