Revascularization in Heart Failure Trial – REHEAT 2
Recruitment status was Not yet recruiting
|First Received Date ICMJE||October 13, 2006|
|Last Updated Date||October 13, 2006|
|Start Date ICMJE||January 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|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|
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.
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||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Completion Date||December 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||19 Years to 90 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Poland|
|NCT Number ICMJE||NCT00388245|
|Other Study ID Numbers ICMJE||0213/P01/2006/31|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Ministry of Science and Higher Education, Poland|
|Collaborators ICMJE||Not Provided|
|Information Provided By||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