Heart FailureNCT00253357
PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy
An observational study of Heart Failure and Congestive Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 28 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive Heart Failure, Cardiomyopathy
- How many people
- 450 participants
- Where
- 28 sitesin 13 countries
- Study dates
- Mar 2004to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
28 sites in 13 countries.
28 sites in 13 countries
United States16 sites
Study site
Atlanta, Georgia
Study site
Burlington, Vermont
Study site
Columbus, Illinois
Study site
Dolyestown, Pennsylvania
Study site
Gainsville, Florida
Study site
Grand Rapids, Michigan
Study site
Kansas City, Kansas
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
Norfolk, Virginia
Study site
Seattle, Washington
Study site
Several Locations, California
Study site
Several Locations, New Jersey
Study site
Several Locations, New York
Study site
Several Locations, Ohio
Study site
Winston-Salem, North Carolina
About this study
Official title: 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.
- Conditions
- Heart Failure, Congestive Heart Failure, Cardiomyopathy
- Keywords
- Heart Failure, Congestive Heart Failure, Fluid overload, Left sided heart failure, Pacemaker, Defibrillator
- Medical subject headings
- Heart Failure, Cardiomyopathies, Edema
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startMar 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Investigators
- William T Abraham, MD, Principal investigator, University of Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253357
- Sponsor's protocol ID
- 226
- Status last verified
- Dec 2007
- First submitted
- 13 Nov 2005
- Last updated
- 21 Dec 2007
- Results posted
- No
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.
PubMed 21956038Chan 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.
PubMed 20466340Chung 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.
PubMed 18458170
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Response to Cardiac Re-Synchronization Therapy
- ClinicalTrials.gov ID
- NCT00253357
- Acronym / sponsor ID
- 226
- Conditions
- Heart Failure, Congestive Heart Failure, Cardiomyopathy
- Keywords
- Heart Failure, Congestive Heart Failure, Fluid overload, Left sided heart failure, Pacemaker, Defibrillator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Mar 2004
- Study completion
- Jun 2006 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Moderate to severe heart failure
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2007.
- Derived from this study: PubMed 21956038Hsing 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.
- Derived from this study: PubMed 20466340Chan 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.
- Derived from this study: PubMed 18458170Chung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William T Abraham, MD principal investigator
University of Ohio
28 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Congestive Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 28 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Austria, Belgium, Denmark, Finland and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00253357, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2007.