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Revascularization in Heart Failure Trial - REHEAT 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00388245
Recruitment Status : Unknown
Verified October 2006 by Ministry of Science and Higher Education, Poland.
Recruitment status was:  Not yet recruiting
First Posted : October 16, 2006
Last Update Posted : October 16, 2006
Information provided by:
Ministry of Science and Higher Education, Poland

Tracking Information
First Submitted Date  ICMJE October 13, 2006
First Posted Date  ICMJE October 16, 2006
Last Update Posted Date October 16, 2006
Study Start Date  ICMJE January 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2006)
LV ejection fraction after 1 year since the index procedure
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2006)
  • in-hospital and 30 day major adverse events (MAE) and major adverse cardiovascular events (MACE) defined as: death, AMI, stroke, acute heart failure, re-CABG, re-PTCA;
  • major adverse coronary and cerebrovascular events during 1 year follow-up (MACCE): death, repeat revascularisation, AMI, unstable angina, heart transplantation, heart failure stroke;
  • long term survival;
  • severity of angina, exercise and functional capacity along with assessment of quality of life in one year observation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Revascularization in Heart Failure Trial - REHEAT 2
Official Title  ICMJE Myocardial Revascularization in Patients With Ischemic Cardiomyopathy: a Comparison Between Percutaneous Coronary Intervention and Coronary Artery Bypass Surgery
Brief Summary REHEAT 2 study is designed as a prospective, randomised trial comparing two strategies of myocardial revascularisation (PCI vs CABG) in patients with ischemic cardiomyopathy and low left ventricular ejection fraction.Patients will undergo in random way PCI or CABG procedure. The aim the study is to assess the improvement of left ventricle systolic function and comparing recent (30 days) and late (12 months) results of surgical (CABG) and percutaneous (PCI) revascularization.
Detailed Description

Heart failure constitutes one of basic problems of contemporary cardiology. It is most commonly caused by ischaemic heart disease, which as an etiologic factor, has a negative impact on prognosis. On the other hand, decreased left ventricular ejection fraction is the most important prognostic factor in patients with ischaemic heart disease. Annual mortality among patients with ejection fraction below 35% accounts for 17%, and in a group with ejection fraction below 25% reaches 24%. Most of multicenter studies (e.g. ARTS, BARI, ERACI) comparing results of percutaneous and surgical revascularisation in ischemic heart disease pertain to patients with normal or minimally decreased left ventricular ejection fraction, excluding patients with left ventricular ejection fraction lower than 35%. Current medical standards indicate the surgical way as a method of choice in treatment of patients with ischemic cardiomyopathy.

In early nineties the procedures of percutaneous angioplasty in patients with depressed left ventricular function were connected with comparable to CABG risk of death (5-10%).

The intensive progress of percutaneous procedures contributed PCI is competitive method of revasularization to CABG. Our knowledge about the efficacy of above mentioned methods in patients with ischemic heart failure is scarce until now. It was proved, that patients with viable myocardium assessed in dobutamine stress echocardiography or MRI benefit mostly from myocardial revascularization. Repeat revascularization during follow up occurred more frequently in patients after PCI, so that introduction of coronary stents, especially drug eluting stents (DES) could significantly improve the clinical outcome after PCI procedures. The administration of antiplatelet drugs (IIb/IIIa platelet receptor inhibitors) have considerably improved the short and long-term results of PCI so that it is interesting if they could have beneficial effect on clinical outcome of patients with ischemic heart failure. In the field of cardiac surgery the method of left ventricle reconstruction in patients with ischemic cardiomyopathy (STICH Trial) seems to be promising.

Therefore, the comparison of innovative methods of percutaneous and surgical revascularization may influence current medical standards concerning patients with ischemic heart disease.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Left Ventricular Ejection Fraction
  • Myocardial Revascularization
  • Ischemic Heart Disease
Intervention  ICMJE
  • Procedure: Percutaneous Coronary Intervention
  • Procedure: Coronary Artery Bypass Grafting
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: October 13, 2006)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • symptomatic coronary artery disease (angina CCS class 1)
  • left ventricle ejection fraction <40%
  • coronary artery lesions suitable for percutaneous or surgical myocardial revascularisation
  • evidence for viability of the myocardium
  • written inform consent for the study

Exclusion Criteria:

  • age <18 years
  • acute myocardial infarct with ST elevation within 30 days
  • concomitant congenital heart disease
  • mitral regurgitation required surgical intervention
  • history of bleeding diathesis, coagulopathy or abnormal bleeding within the previous 30 days.
  • major surgery within the previous 6 weeks
  • stroke or transient ischemic attack (TIA) within the previous 6 weeks
  • history of hemorrhagic stroke
  • uncontrolled hypertension
  • chronic renal insufficiency with creatinine >2.0 mg/dl
  • platelet count <100.000/mm3
  • hematocrit <30%
  • PT >1,2 times control
  • positive pregnancy test
  • any disease that may shorten the life expectancy of the patient
  • the patient is currently participating in another research study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00388245
Other Study ID Numbers  ICMJE 0213/P01/2006/31
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Ministry of Science and Higher Education, Poland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pawel E Buszman, Prof 3-rd Division of Cardiology, University School of Silesia, Poland
Study Chair: Michal Tendera, Prof 3-rd Division of Cardiology, University School of Silesia, Poland
Principal Investigator: Andrzej Bochenek, Prof 1-st Division of Cardiosurgery, University School of Silesia, Poland
Principal Investigator: Robert J Gil, Prof Invasive Cardiology Department, Central Clinic Hospital, Warsaw, Poland
Principal Investigator: Piotr Ponikowski, Prof Heart Disease Department, Military Clinic Hospital, Wroclaw, Poland
PRS Account Ministry of Science and Higher Education, Poland
Verification Date October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP