End Stage Heart DiseaseNCT02387112
Early Versus Emergency Left Ventricular Assist Device Implantation in Patients Awaiting Cardiac Transplantation
A study testing Early VAD implantation in people with End Stage Heart Disease, run by German Heart Institute at 18 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- End Stage Heart Disease
- What is being tested?
- Early VAD implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 18 sitesGermany
- Study dates
- Jul 2015to Dec 2024
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient (male or female) eligible for heart transplantation and accepted in T Status (transplantable) on the waiting list
- Age 18 to 65 years
- Signed informed consent
- >30% 1-year mortality with the Seattle Heart Failure Model (SHFM) or at least three of the following criteria (a) to (f):
- cardiac index (CI) <2.5 l/min/m²
- pulmonary capillary wedge pressure >15 mmHg
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- maximal oxygen uptake (VO2max) ≤10.0 ml/kg/min or ≤12.0 ml/kg/min in patients intolerant of a ß-blocker
- ratio of minute ventilation (VE) to carbon dioxide (VCO2) production (VE/VCO2) slope of >35
- at least two hospitalizations for heart failure within the previous 12 months
- documented increase of brain natriuretic peptide (BNP) or NTproBNP levels despite optimal medical therapy
Who cannot join
- Listing for transplantation of other organs in addition to heart
- Previous cardiac surgeries (other than pacemaker or ICD surgeries)
- Contraindications to assist device implantation (e.g. mechanical aortic valve, aortic insufficiency)
- Contraindications to anticoagulation
- Expected need for a right ventricular assist device/biventricular support expected (e.g. due to tricuspid valve insufficiency grade 3+, right ventricular ratio short/long axis ≥0.6, ratio of right to left ventricular end-diastolic diameter (RVEDD/LVEDD) >0.72, restrictive cardiomyopathy)
- Presence of catecholamine support or intra-aortic balloon counterpulsation (IABP)
Show all 16Show fewer
- Overt infections
- Fixed pulmonary hypertension (i.e. pulmonary arterial pressure (PAP) >60 mmHg and mean transpulmonary gradient (TPG) >15 mmHg or pulmonary vascular resistance (PVR) >6 Wood units despite optimal medical treatment)
- Renal insufficiency (glomerular filtration rate (GFR) <30ml/min or need for hemodialysis or hemofiltration)
- Significant coagulopathies
- Systemic lupus erythematosus, sarcoid, or amyloidosis that has multisystem involvement and is still active
- Drug abuse and/or alcohol abuse
- Incompliance
- Elevated panel reactivity levels of >50 %
- Pregnancy or breast feeding in women
- Participation in other investigational trials
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Germany18 sites
Universitäts-Herzzentrum Freiburg Bad Krozingen - Klinik für Herz- und Gefäßchirurgie
Bad Krozingen, 79189
Kerckhoff Klinik Bad Nauheim
Bad Nauheim, 61231
Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum
Bad Oeynhausen, 32545
Charité - Universitätsmedizin Berlin: Campus Benjamin Franklin
Berlin, 12203
German Heart Center Berlin
Berlin, 13353
Universitätsklinikum Erlangen - Herzchirurgische Klinik
Erlangen, 91054
Universitätsklinikum Frankfurt - Klinik für Thorax-, Herz- und thorakale Gefäßchirurgie
Frankurt Am Main, 60590
Universitätsmedizin Göttingen
Göttingen, 37075
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Med. Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie
Hanover, 30625
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsklinikum Jena, Klinik für Herz- und Thoraxchirurgie
Jena, 07747
Universitätsklinikum Schleswig Holstein - Campus Kiel
Kiel, 24105
Heart Center Leipzig
Leipzig, 04289
Universitätsklinik für Herz- und Thoraxchirurgie
Magdeburg, 39120
Universitätsklinikum Gießen und Marburg Klinik für Herz- und thorakale Gefäßchirurgie
Marburg, 35043
Herzchirurgische Klinik und Poliklinik des Klinikums der Universität München - Campus Großhadern
München, 81377
Universitätskrankenhaus Münster
Münster, 48149
About this study
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.
Read the 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.
- Conditions
- End Stage Heart Disease
- Being tested
- Early VAD implantation
- Keywords
- End stage heart disease, Ventricular assist device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early VAD implantationDevice
Implantation of a left ventricular assist device
| Study group | Role | What they receive |
|---|---|---|
| Early VAD implantation | Experimental | 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. Receives: Device: Early VAD implantation |
| Emergency VAD implantation | No intervention | The control intervention is conservative heart failure treatment, with LVAD implantation in the case of worsening heart failure (emergency VAD). All patients randomized to the control intervention will be treated according to standard medical practice. In brief, these patients are closely monitored (scheduled regular visits to outpatient department depending on the patient's condition and at least every 6 months). If the condition worsens the patient may qualify for high urgency (HU) listing and/or for VAD implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
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).
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Secondary outcomes (21)
Stroke
Freedom from disabling and non-disabling strokes
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Listing for high-urgency (HU) cardiac transplantation
Measured: 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
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Number of patients with hospitalizations due to device failure
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Number of patients with adverse events due to device failure
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Number of device infections requiring antibiotics and/surgical intervention
Measured: 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
Bleeding needing hospitalisation, blood transfusion and/or surgical interventions
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Cardiovascular Death
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Number of patients suffering from secondary organ failure
Time to event of renal and/or hepatic failure
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Maximum oxygen uptake (VO2 max)
Measured: Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average)
Heart failure survival score
Measured: Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average)
Seattle heart failure score
Measured: Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average)
New York Heart Association class (NYHA)
Measured: 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
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Rate of recurrent hospitalizations
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Number of patients receiving a donor heart
Measured: Randomisation untill transplantation (60 months at the most, 48 months on average)
VAD explantation due to myocardial recovery
Time to event
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Short Form-36 (SF-36)
Quality of life questionnaire (QoL)
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Minnesota Living with heart failure questionnaire (MLHFQ)
Quality of life questionnaire (QoL)
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Mini-mental state examination (MMSE)
Quality of life questionnaire (QoL)
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Quality-adjusted life year (QALY)
Measured: Randomisation untill month 60 (60 months at the most, 48 months on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Heart DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Helmholtz Zentrum München, University Medicine Greifswald, University of Göttingen
- Responsible party
- Sponsor
- Investigators
- Volkmar Falk, MD, PhD, Principal investigator, German Heart Institute Berlin Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387112
- Sponsor's protocol ID
- DZHK VAD Study
- Other IDs
- VAD Study Germany
- Status last verified
- Oct 2023
- First submitted
- 24 Jun 2013
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Emergency Left Ventricular Assist Device Implantation in Patients Awaiting Cardiac Transplantation
- ClinicalTrials.gov ID
- NCT02387112
- Acronym / sponsor ID
- DZHK VAD Study
- Conditions
- End Stage Heart Disease
- Keywords
- End stage heart disease, Ventricular assist device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Helmholtz Zentrum München, University Medicine Greifswald, University of Göttingen
- Study start
- Jul 2015 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Mar 2015 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early VAD implantation | Experimental | Device: Early VAD implantationThe 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. |
| Emergency VAD implantation | No intervention | –The control intervention is conservative heart failure treatment, with LVAD implantation in the case of worsening heart failure (emergency VAD). All patients randomized to the control intervention will be treated according to standard medical practice. In brief, these patients are closely monitored (scheduled regular visits to outpatient department depending on the patient's condition and at least every 6 months). If the condition worsens the patient may qualify for high urgency (HU) listing and/or for VAD implantation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient (male or female) eligible for heart transplantation and accepted in T Status (transplantable) on the waiting list
- Age 18 to 65 years
- Signed informed consent
- >30% 1-year mortality with the Seattle Heart Failure Model (SHFM) or at least three of the following criteria (a) to (f):
Key exclusion criteria (16 listed)
- Listing for transplantation of other organs in addition to heart
- Previous cardiac surgeries (other than pacemaker or ICD surgeries)
- Contraindications to assist device implantation (e.g. mechanical aortic valve, aortic insufficiency)
- Contraindications to anticoagulation
- Expected need for a right ventricular assist device/biventricular support expected (e.g. due to tricuspid valve insufficiency grade 3+, right ventricular ratio short/long axis ≥0.6, ratio of right to left ventricular end-diastolic diameter (RVEDD/LVEDD) >0.72, restrictive cardiomyopathy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early VAD implantationImplantation of a left ventricular assist device | Device | Early VAD implantation |
Primary outcome
Event-free survival
Time frame: 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).
21 secondary outcomes
Stroke
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Listing for high-urgency (HU) cardiac transplantation
Time frame: 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
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Number of patients with hospitalizations due to device failure
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Number of patients with adverse events due to device failure
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Number of device infections requiring antibiotics and/surgical intervention
Time frame: 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
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Cardiovascular Death
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Number of patients suffering from secondary organ failure
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Maximum oxygen uptake (VO2 max)
Time frame: Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average)
Heart failure survival score
Time frame: Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average)
Seattle heart failure score
Time frame: Measured every 6 months from randomisation untill month 60 (60 months at the most, 48 months on average)
New York Heart Association class (NYHA)
Time frame: 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
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Rate of recurrent hospitalizations
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Number of patients receiving a donor heart
Time frame: Randomisation untill transplantation (60 months at the most, 48 months on average)
VAD explantation due to myocardial recovery
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Short Form-36 (SF-36)
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Minnesota Living with heart failure questionnaire (MLHFQ)
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Mini-mental state examination (MMSE)
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Quality-adjusted life year (QALY)
Time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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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.
Volkmar Falk, MD, PhD principal investigator
German Heart Institute Berlin Germany
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early VAD implantation in people with End Stage Heart Disease, run by German Heart Institute at 18 sites in Germany.
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 10 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany. 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Event-free survival (time frame: Randomisation untill month 60 (60 months at the most, 48 months on average)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2023.