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Left Ventricular Ejection FractionPhase 4NCT00388245

Revascularization in Heart Failure Trial - REHEAT 2

A Phase 4 study testing Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting in people with Left Ventricular Ejection Fraction and Myocardial Revascularization, run by Ministry of Science and Higher Education, Poland at 4 sites in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 90 years
What is being tested?
Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting
Type of treatment
Surgery or procedure
How many people
150 participants
Where
4 sitesPoland
Study dates
Jan 2007to Dec 2008
Phase
Phase 4
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 19 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Pawel E Buszman, Prof contact

+48 32 252 72 12

pbuszman@ka.onet.pl

Iwona Szkrobka, MD contact

+48 602 457 602

wilenka@wp.pl

Poland4 sites

  • University School of Silesia, 1-st Department of Cardiosurgery

    Katowice, Silesian Voivodeship, 40-635

    Andrzej Bochenek, Prof

  • University School of Silesia, 3-rd Department of Cardiology, Coronary Care Unit

    Katowice, Silesian Voivodeship, 40-635

    Pawel E Buszman, Prof

    Iwona Szkrobka, MD

  • Central Clinic Hospital

    Warsaw, 02-507

    Robert J Gil, Prof

  • Military Clinic Hospital

    Wroclaw, 50-981

    Piotr Ponikowski, Prof

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Being tested
Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting
Keywords
PCI, CABG, Ejection Fraction, Myocardial Revascularization
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Coronary InterventionProcedure or surgery

  • Coronary Artery Bypass GraftingProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LV ejection fraction after 1 year since the index procedure

Secondary outcomes (4)

  1. 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;

  2. major adverse coronary and cerebrovascular events during 1 year follow-up (MACCE): death, repeat revascularisation, AMI, unstable angina, heart transplantation, heart failure stroke;

  3. long term survival;

  4. severity of angina, exercise and functional capacity along with assessment of quality of life in one year observation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2006 (estimated)
  2. Study startJan 2007
  3. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00388245
Sponsor's protocol ID
0213/P01/2006/31
Status last verified
Oct 2006
First submitted
13 Oct 2006
Last updated
16 Oct 2006
Results posted
No

Publications

  • Serruys PW, Ong AT, van Herwerden LA, Sousa JE, Jatene A, Bonnier JJ, Schonberger JP, Buller N, Bonser R, Disco C, Backx B, Hugenholtz PG, Firth BG, Unger F. Five-year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: the final analysis of the Arterial Revascularization Therapies Study (ARTS) randomized trial. J Am Coll Cardiol. 2005 Aug 16;46(4):575-81. doi: 10.1016/j.jacc.2004.12.082.

    PubMed 16098418

  • Scholz KH, Dubois-Rande JL, Urban P, Morice MC, Loisance D, Smalling RW, Figulla HR. Clinical experience with the percutaneous hemopump during high-risk coronary angioplasty. Am J Cardiol. 1998 Nov 1;82(9):1107-10, A6. doi: 10.1016/s0002-9149(98)00566-9.

    PubMed 9817489

  • Shawl FA, Quyyumi AA, Bajaj S, Hoff SB, Dougherty KG. Percutaneous cardiopulmonary bypass-supported coronary angioplasty in patients with unstable angina pectoris or myocardial infarction and a left ventricular ejection fraction < or = 25%. Am J Cardiol. 1996 Jan 1;77(1):14-9. doi: 10.1016/s0002-9149(97)89127-8.

    PubMed 8540450

  • Van Belle E, Blouard P, McFadden EP, Lablanche JM, Bauters C, Bertrand ME. Effects of stenting of recent or chronic coronary occlusions on late vessel patency and left ventricular function. Am J Cardiol. 1997 Nov 1;80(9):1150-4. doi: 10.1016/s0002-9149(97)00631-0.

    PubMed 9359541

  • Bax JJ, Poldermans D, Elhendy A, Cornel JH, Boersma E, Rambaldi R, Roelandt JR, Fioretti PM. Improvement of left ventricular ejection fraction, heart failure symptoms and prognosis after revascularization in patients with chronic coronary artery disease and viable myocardium detected by dobutamine stress echocardiography. J Am Coll Cardiol. 1999 Jul;34(1):163-9. doi: 10.1016/s0735-1097(99)00157-6.

    PubMed 10400006

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting in people with Left Ventricular Ejection Fraction and Myocardial Revascularization, run by Ministry of Science and Higher Education, Poland at 4 sites in Poland.

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 16 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: status not confirmed, as of the sponsor's last update on 16 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Poland. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pawel E Buszman, Prof (+48 32 252 72 12, pbuszman@ka.onet.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LV ejection fraction after 1 year since the index procedure. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00388245, which also lists 5 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 16 Oct 2006.

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