Heart Failure Clinical Trial
Official title:
Right Ventricular Failure After Implantation of Left Ventricular Assist Devices
Verified date | May 2018 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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:
1. 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?
2. 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.
Status | Completed |
Enrollment | 83 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Age 18-75 years - Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Class 2-7 - Willing to participate - Able to give consent Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | American Heart Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 90 days | |
Secondary | Quality of life | QoL by Kansas City Cardiomyopathy Questionnaire at 90 days defined as summary score <45 | 90 days | |
Secondary | Right ventricular recovery | RV recovery, defined as 5% improvement in RV fractional area change at 30 days and 90 days | 30 and 90 days |
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