Clinical trial NCT00253357: PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy
Official title: Predictors of Response to Cardiac Re-Synchronization Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Congestive Heart Failure
Cardiomyopathy
Keywords: Heart Failure
Congestive Heart Failure
Fluid overload
Left sided heart failure
Pacemaker
Defibrillator
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2005-11-15
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Several locations
country: United States
state: California
city: Gainsville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Columbus
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Grand Rapids
country: United States
state: Michigan
city: Several locations
country: United States
state: New Jersey
city: Several locations
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Several locations
country: United States
state: Ohio
city: Dolyestown
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Burlington
country: United States
state: Vermont
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Several locations
country: Austria
city: Several locations
country: Belgium
city: Several locations
country: Denmark
city: Several locations
country: Finland
city: Several locations
country: France
city: Several locations
country: Germany
city: Several locations
country: Hong Kong
city: Several locations
country: Italy
city: Several locations
country: Netherlands
city: Several locations
country: Norway
city: Several locations
country: Spain
city: Several locations
country: United Kingdom
Study officials:
affiliation: University of Ohio
name: William T Abraham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.