Early Versus Emergency Left Ventricular Assist Device Implantation in Patients Awaiting Cardiac Transplantation
- Conditions
- End Stage Heart Disease
- Interventions
- Device: Early VAD implantation
- Registration Number
- NCT02387112
- Lead Sponsor
- German Heart Institute
- Brief Summary
The aim of the study is to assess whether, in patients who are listed for cardiac transplantation in transplantable (T) status, early implantation of a left ventricular assist device is superior to the current therapeutic strategy of medical heart failure therapy and assist device implantation only after serious deterioration of the patient's condition.
- Detailed Description
Heart transplantation is considered the gold-standard therapy for end-stage systolic heart failure but the shortage of donor hearts in Germany and other countries has led to widespread use of left ventricular assist devices (LVAD). Even on the transplant list, patients' condition often deteriorate due to worsening heart failure so that they need an LVAD as a bridge until transplantation. The high mortality (one in five patients on the waiting list dies within 1 year) reflects the severity of the disease. In comparison, technical progress has reduced the complication rate seen with assist devices and, according to recent data, mortality during LVAD support is low. Patient status prior to LVAD implantation is a strong indicator for postoperative outcome, i.e. patients in worse condition are more likely to develop complications. Thus, the comparison between the standard indication and early LVAD implantation (T-status) appears timely and clinically necessary.
The paucity of donor hearts necessitates the prospective evaluation of alternative treatment regimens. The aim of the study is to assess whether, in patients with end-stage heart failure awaiting cardiac transplantation, a strategy involving early LVAD implantation is superior to a strategy of conservative medical heart failure therapy and assist device implantation only after severe deterioration of heart failure.
The investigators expect to gain insights that will be trail-blazing for the future treatment of patients with heart failure on the transplantation waiting list, including aspects of their medical care. If the study hypotheses are confirmed, the treatment of these seriously ill patients could be, on the one hand, further optimized. On the other hand, positive economic effects are highly probable.
The results will form the basis of future guidelines for the treatment of this group of patients.
Thus the study will also make a contribution to solving the problem of the ever increasing number of patients on the waiting list as opposed to the decreasing willingness to donate organs for transplantation.
As a mean of quality control of the conducted study and to retrieve more data in this population all patients who fulfill the eligibility criteria of the study but do not consent to randomization are included in a standard treatment registry.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 102
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early VAD implantation Early VAD implantation The experimental intervention is early implantation of a left ventricular assist device (early VAD). Patients randomized to early VAD implantation will obtain a VAD within 28 days after randomization.
- Primary Outcome Measures
Name Time Method Event-free survival Randomisation untill month 60 (60 months at the most, 48 months on average) The time to the composite end-point of all-cause death, high urgent cardiac transplantation, disabling stroke , HF hospitalizations (including emergency room HF visits \>6 hrs).
- Secondary Outcome Measures
Name Time Method Heart failure survival score Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average) Seattle heart failure score Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average) Number of patients requiring urgent VAD implantation Randomisation untill month 60 (60 months at the most, 48 months on average) Number of patients receiving a donor heart Randomisation untill transplantation (60 months at the most, 48 months on average) VAD explantation due to myocardial recovery Randomisation untill month 60 (60 months at the most, 48 months on average) Time to event
Short Form-36 (SF-36) Randomisation untill month 60 (60 months at the most, 48 months on average) Quality of life questionnaire (QoL)
Minnesota Living with heart failure questionnaire (MLHFQ) Randomisation untill month 60 (60 months at the most, 48 months on average) Quality of life questionnaire (QoL)
Mini-mental state examination (MMSE) Randomisation untill month 60 (60 months at the most, 48 months on average) Quality of life questionnaire (QoL)
Quality-adjusted life year (QALY) Randomisation untill month 60 (60 months at the most, 48 months on average) Cardiovascular Death Randomisation untill month 60 (60 months at the most, 48 months on average) Rate of recurrent hospitalizations Randomisation untill month 60 (60 months at the most, 48 months on average) Stroke Randomisation untill month 60 (60 months at the most, 48 months on average) Freedom from disabling and non-disabling strokes
Listing for high-urgency (HU) cardiac transplantation Randomisation untill month 60 (60 months at the most, 48 months on average) Number of patients with de novo right heart failure measured by decreasing right heart ejection fraction, increasing central venous pressure and/or secondary organ failure needing catecholamines and/or right ventricular circulatory support Randomisation untill month 60 (60 months at the most, 48 months on average) Number of patients with adverse events due to device failure Randomisation untill month 60 (60 months at the most, 48 months on average) Number of device infections requiring antibiotics and/surgical intervention Randomisation untill month 60 (60 months at the most, 48 months on average) Number of patients with hospitalizations due to device failure Randomisation untill month 60 (60 months at the most, 48 months on average) Number of patients with major bleedings (needing >4 Units of blood) following VAD implantation and major bleedings due to anticoagulation therapy Randomisation untill month 60 (60 months at the most, 48 months on average) Bleeding needing hospitalisation, blood transfusion and/or surgical interventions
Maximum oxygen uptake (VO2 max) Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average) Number of patients suffering from secondary organ failure Randomisation untill month 60 (60 months at the most, 48 months on average) Time to event of renal and/or hepatic failure
New York Heart Association class (NYHA) Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average)
Trial Locations
- Locations (18)
Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum
🇩🇪Bad Oeynhausen, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitätskrankenhaus Münster
🇩🇪Münster, Germany
German Heart Center Berlin
🇩🇪Berlin, Germany
Universitäts-Herzzentrum Freiburg Bad Krozingen - Klinik für Herz- und Gefäßchirurgie
🇩🇪Bad Krozingen, Germany
Charité - Universitätsmedizin Berlin: Campus Benjamin Franklin
🇩🇪Berlin, Germany
Kerckhoff Klinik Bad Nauheim
🇩🇪Bad Nauheim, Germany
Universitätsklinikum Erlangen - Herzchirurgische Klinik
🇩🇪Erlangen, Germany
Universitätsklinikum Frankfurt - Klinik für Thorax-, Herz- und thorakale Gefäßchirurgie
🇩🇪Frankurt am Main, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinikum Schleswig Holstein - Campus Kiel
🇩🇪Kiel, Germany
Universitätsklinikum Jena, Klinik für Herz- und Thoraxchirurgie
🇩🇪Jena, Germany
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
Med. Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie
🇩🇪Hannover, Germany
Heart Center Leipzig
🇩🇪Leipzig, Germany
Universitätsklinik für Herz- und Thoraxchirurgie
🇩🇪Magdeburg, Germany
Universitätsklinikum Gießen und Marburg Klinik für Herz- und thorakale Gefäßchirurgie
🇩🇪Marburg, Germany
Herzchirurgische Klinik und Poliklinik des Klinikums der Universität München - Campus Großhadern
🇩🇪München, Germany