Heart FailureNCT01999712
Right Ventricular Failure After Implantation of Left Ventricular Assist Devices
An observational study of Heart Failure, run by Emory University at 1 site in United States.
Trial summary
The left ventricular assist device (LVAD) is a portable mechanical pump that helps the left side of the heart of patients with severe heart failure that are awaiting heart transplantation or are not transplant candidates. However, while LVAD supports the left side of the heart, the right side must work on its own. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 31 Dec 2017
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible for LVAD implantation seen at Emory University Hospital
Who may be able to join
- Age 18-75 years
- Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Class 2-7
- Willing to participate
- Able to give consent
Who cannot join
- INTERMACS Class 1
- Pre-operative advanced RVF, defined as planned or anticipated need for RVAD or extracorporeal membrane oxygenation at surgery
- Unresponsive pulmonary vascular resistance (PVR) >6 Wood units
Trial locations and contacts
1 site in 1 country.
About this study
The left ventricular assist device (LVAD) is a portable mechanical pump that helps the left side of the heart of patients with severe heart failure that are awaiting heart transplantation or are not transplant candidates. However, while LVAD supports the left side of the heart, the right side must work on its own. Sometimes the right side does not recover, a condition called right ventricular failure (RVF). This complication increases mortality, prolongs hospitalization, requires additional procedures, and increases costs. Several risk factors and scores have been proposed to identify patients at risk for RVF. However, these methods have proven inadequate; one out of three patients is still experiencing right ventricular failure after LVAD surgery.
Echocardiography, an established noninvasive method to see the heart without radiation or risk, has a lot of potential to identify patients at risk for RVF. The questions we will tray to answer with this American Heart Association funded project are:
Read more
- Can echocardiography before scheduled LVAD surgery predict who is going to develop RVF and poor quality of life so we can better select patients for LVAD surgery?
- Can echocardiography before scheduled LVAD surgery tell us the course of right ventricular function after implantation so we can potentially take additional measures and prevent RVF?
To answer these questions, we will record images of the heart with echocardiography before LVAD surgery in 120 LVAD recipients at Emory University. We will then follow the patients for 90 days to detect any symptoms and signs of clinical RVF and poor quality of life and record the course of right ventricular function with echocardiography.
Currently, it is estimated that 150,000 to 250,000 patients in US are potential LVAD recipients with 2,000 devices implanted in 2012. LVAD can improve survival and quality of life in suitable patients. However, implantation requires a major surgical procedure with associated risks and considerable resources. Thus, careful patient selection is necessary to minimize risk for patients and maximize benefit for patients and society. Our long-term goal is to use echocardiography as a tool to (1) optimally select patients for LVAD and offer alternatives to patients at increased risk for complications and (2) potentially, inform earlier LVAD implantation in patients with weakening right ventricular function.
Read the detailed description
Despite (1) improved outcomes and lower rates of right ventricular failure (RVF) with the newer, continuous-flow left ventricular assist devices (LVAD) over pulsatile-flow devices and (2) development of clinical prediction scores to identify patients at risk for RVF post LVAD, RVF still occurs in 20% to 40% of recipients, even with the newer devices.
In 2012, 2000 LVADs were implanted in U.S. and the number is rapidly increasing. Post-LVAD outcomes depend critically on right ventricular (RV) function. RVF can lead to:
- Reduced survival and progression to transplant (Tx) and worse post-Tx outcomes
- Significantly higher rates of resources utilization
- Long-term poor exercise capacity and quality of life (QoL)
True echocardiographic quantification of RV function has only recently been considered in RVF prediction post LVAD; however these studies were retrospective and had inconsistent population and outcome definitions. Also, despite promising results in a retrospective study, preoperative RV mechanics have not been prospectively evaluated as RVF predictors to date.
In this study, we plan to enroll a total of 120 LVAD candidates to evaluate standard and mechanics-based echocardiographic measures of RV function for prediction of (1) RVF within 90 days; (2) QoL at 90 days; and (3) RV recovery at 90 days post LVAD implantation.
Aim 1: We will perform echocardiography within 7 days of planned LVAD surgery to evaluate the association of prespecified RV parameters with (1) RVF within 90 days and (2) QoL at 90 days. Our main hypotheses is an RV echo score will predict RVF within 90 days post LVAD with clinically relevant discrimination (C>0.85) and positive and negative predictive values (>80%). Our secondary hypothesis is that the RV score will predict poor QoL at 90 days with clinically relevant discrimination and predictive values.
Aim 2: We will repeat echocardiograms at 30 and 90 days post LVAD surgery to examine the association of baseline RV function with RV recovery. Our hypothesis is that the RV score will predict RV function recovery post LVAD and that RV mechanics will have incremental value for prediction of these outcomes.
These results may help improve LVAD outcomes and reduce resource utilization by facilitating shared decision-making and selection for LVAD vs. alternatives; provide insights into RV function recovery; and inform reassessment of LVAD timing.
- Conditions
- Heart Failure
- Being tested
- Echocardiography
- Keywords
- heart failure, left ventricular assist device, right ventricular failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyProcedure or surgery
Patients will undergo an echocardiogram at baseline (preoperative) and at 30 and 90 days after LVAD implantation
| Study group | Role | What they receive |
|---|---|---|
| LVAD recipients | Patients who are scheduled for LVAD implantation will undergo preoperative echocardiography Receives: Procedure: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular failure
Right ventricular failure (RVF) at 90 days, defined as RVF-related death (multi-organ failure), need for inhaled nitric oxide postoperatively for ≥48h, need for post-operative inotropes for ≥14 days, reinstitution of inotropes beyond 14 days, or need for a RV assist device (RVAD)
Measured: 90 days
Secondary outcomes (2)
Quality of life
QoL by Kansas City Cardiomyopathy Questionnaire at 90 days defined as summary score <45
Measured: 90 days
Right ventricular recovery
RV recovery, defined as 5% improvement in RV fractional area change at 30 days and 90 days
Measured: 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startJul 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Kunal Bhatt, Emory University
- Investigators
- Andreas P Kalogeropoulos, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999712
- Sponsor's protocol ID
- IRB00058588
- Other IDs
- 13SDG15960001
- Status last verified
- May 2018
- First submitted
- 26 Nov 2013
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Failure After Implantation of Left Ventricular Assist Devices
- ClinicalTrials.gov ID
- NCT01999712
- Acronym / sponsor ID
- IRB00058588
- Conditions
- Heart Failure
- Keywords
- heart failure, left ventricular assist device, right ventricular failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jul 2013
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 3 Dec 2013 (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 left ventricular assist device (LVAD) is a portable mechanical pump that helps the left side of the heart of patients with severe heart failure that are awaiting heart transplantation or are not transplant candidates. However, while LVAD supports the left side of the heart, the right side must work on its own. Sometimes the right side does not recover, a condition called right ventricular failure (RVF). This complication increases mortality, prolongs hospitalization, requires additional procedures, and increases costs. Several risk factors and scores have been proposed to identify patients at risk for RVF. However, these methods have proven inadequate; one out of three patients is still experiencing right ventricular failure after LVAD surgery.
Echocardiography, an established noninvasive method to see the heart without radiation or risk, has a lot of potential to identify patients at risk for RVF. The questions we will tray to answer with this American Heart Association funded project are:
- Can echocardiography before scheduled LVAD surgery predict who is going to develop RVF and poor quality of life so we can better select patients for LVAD surgery?
- Can echocardiography before scheduled LVAD surgery tell us the course of right ventricular function after implantation so we can potentially take additional measures and prevent RVF?
To answer these questions, we will record images of the heart with echocardiography before LVAD surgery in 120 LVAD recipients at Emory University. We will then follow the patients for 90 days to detect any symptoms and signs of clinical RVF and poor quality of life and record the course of right ventricular function with echocardiography.
Currently, it is estimated that 150,000 to 250,000 patients in US are potential LVAD recipients with 2,000 devices implanted in 2012. LVAD can improve survival and quality of life in suitable patients. However, implantation requires a major surgical procedure with associated risks and considerable resources. Thus, careful patient selection is necessary to minimize risk for patients and maximize benefit for patients and society. Our long-term goal is to use echocardiography as a tool to (1) optimally select patients for LVAD and offer alternatives to patients at increased risk for complications and (2) potentially, inform earlier LVAD implantation in patients with weakening right ventricular function.
Detailed description
Despite (1) improved outcomes and lower rates of right ventricular failure (RVF) with the newer, continuous-flow left ventricular assist devices (LVAD) over pulsatile-flow devices and (2) development of clinical prediction scores to identify patients at risk for RVF post LVAD, RVF still occurs in 20% to 40% of recipients, even with the newer devices.
In 2012, 2000 LVADs were implanted in U.S. and the number is rapidly increasing. Post-LVAD outcomes depend critically on right ventricular (RV) function. RVF can lead to:
- Reduced survival and progression to transplant (Tx) and worse post-Tx outcomes
- Significantly higher rates of resources utilization
- Long-term poor exercise capacity and quality of life (QoL)
True echocardiographic quantification of RV function has only recently been considered in RVF prediction post LVAD; however these studies were retrospective and had inconsistent population and outcome definitions. Also, despite promising results in a retrospective study, preoperative RV mechanics have not been prospectively evaluated as RVF predictors to date.
In this study, we plan to enroll a total of 120 LVAD candidates to evaluate standard and mechanics-based echocardiographic measures of RV function for prediction of (1) RVF within 90 days; (2) QoL at 90 days; and (3) RV recovery at 90 days post LVAD implantation.
Aim 1: We will perform echocardiography within 7 days of planned LVAD surgery to evaluate the association of prespecified RV parameters with (1) RVF within 90 days and (2) QoL at 90 days. Our main hypotheses is an RV echo score will predict RVF within 90 days post LVAD with clinically relevant discrimination (C>0.85) and positive and negative predictive values (>80%). Our secondary hypothesis is that the RV score will predict poor QoL at 90 days with clinically relevant discrimination and predictive values.
Aim 2: We will repeat echocardiograms at 30 and 90 days post LVAD surgery to examine the association of baseline RV function with RV recovery. Our hypothesis is that the RV score will predict RV function recovery post LVAD and that RV mechanics will have incremental value for prediction of these outcomes.
These results may help improve LVAD outcomes and reduce resource utilization by facilitating shared decision-making and selection for LVAD vs. alternatives; provide insights into RV function recovery; and inform reassessment of LVAD timing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LVAD recipients | – | Procedure: EchocardiographyPatients who are scheduled for LVAD implantation will undergo preoperative echocardiography |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for LVAD implantation seen at Emory University Hospital
Key inclusion criteria (4 listed)
- Age 18-75 years
- Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Class 2-7
- Willing to participate
- Able to give consent
Key exclusion criteria (3 listed)
- INTERMACS Class 1
- Pre-operative advanced RVF, defined as planned or anticipated need for RVAD or extracorporeal membrane oxygenation at surgery
- Unresponsive pulmonary vascular resistance (PVR) >6 Wood units
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 |
|---|---|---|
| EchocardiographyPatients will undergo an echocardiogram at baseline (preoperative) and at 30 and 90 days after LVAD implantation | Procedure or surgery | LVAD recipients |
Primary outcome
Right ventricular failure
Time frame: 90 days
Right ventricular failure (RVF) at 90 days, defined as RVF-related death (multi-organ failure), need for inhaled nitric oxide postoperatively for ≥48h, need for post-operative inotropes for ≥14 days, reinstitution of inotropes beyond 14 days, or need for a RV assist device (RVAD)
2 secondary outcomes
Quality of life
Time frame: 90 days
Right ventricular recovery
Time frame: 30 and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
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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.
Andreas P Kalogeropoulos, MD, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Emory University at 1 site in United States.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Right ventricular failure (time frame: 90 days). 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 31 May 2018.