Right Ventricular Failure After Implantation of Left Ventricular Assist Devices

NCT01999712 | Completed

• 2 other identifiers: IRB0005858813SDG15960001
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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?

Conditions

Heart Failure

Keywords

heart failure; left ventricular assist device; right ventricular failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Quality of life

  90 days

• Right ventricular recovery

  30 and 90 days

Study Arms (1)

LVAD recipients

Patients who are scheduled for LVAD implantation will undergo preoperative echocardiography

Procedure: Echocardiography

Interventions

Echocardiography PROCEDURE

Patients will undergo an echocardiogram at baseline (preoperative) and at 30 and 90 days after LVAD implantation

LVAD recipients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for LVAD implantation seen at Emory University Hospital

You may qualify if:

• Age 18-75 years
• Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Class 2-7
• Willing to participate
• Able to give consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• American Heart Association: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma will be stored for biomarkers analysis

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Andreas P Kalogeropoulos, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: July 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: May 31, 2018

Record last verified: 2018-05

Locations

US (1)