Identifying and Facilitating Ventricular Recovery in People With Heart Failure Who Are on Mechanical Support (The RECOVER Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
John Gorcsan, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00687856
First received: May 29, 2008
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

Heart failure is a progressive disorder in which the weakened heart is not able to efficiently pump blood throughout the body. When the body's cells do not receive enough blood, this can result in fatigue, shortness of breath, and difficulty carrying out daily activities. The left ventricular assist device (LVAD) is a device that is used to provide mechanical circulatory support to patients with end-stage heart failure who are awaiting heart transplants. Although LVAD support helps maintain the pumping ability of the heart and dramatically improves heart failure symptoms, the quality of life with LVAD support is far from ideal. It has been shown that LVAD support in selected patients may restore the failing heart enough to eliminate the need for heart transplant, but more information is needed to assess heart recovery and to guide weaning of LVAD support. Using data collected from patients who have undergone LVAD implantation, this study will attempt to better assess heart recovery and to generate criteria for identifying patients eligible for the removal of LVAD support.


Condition Intervention
Heart Failure
Procedure: Echocardiogram (echo)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identifying and Facilitating Ventricular Recovery on Mechanical Support

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Noninvasive determination of left ventricular function using novel echocardiographic imaging methods and routine clinical assessments to optimize markers of left ventricular recovery [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Refine and test feedback control algorithm that allows precise prescription of cardiac loading through synchronized and asynchronized LVAD operation with native left ventricular contraction [ Time Frame: Measured at Year 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: April 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Participants who have had or are about to have a left ventricular assist device (LVAD) implanted
Procedure: Echocardiogram (echo)
Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts.

Detailed Description:

It is estimated that approximately 5 million people in the United States have heart failure, with more than 500,000 new cases diagnosed each year. Heart failure is a disorder that develops over many years and can be attributed to a number of conditions, including heart attack, coronary artery disease, diabetes, high blood pressure, or congenital heart defects. Although there are many treatment options for heart failure, people with end-stage heart failure may benefit most from a heart transplant. However, the number of donor organs available remains limited, making alternative treatments for people with end-stage heart failure imperative. LVAD support, which has traditionally been used as a bridge to transplant, may also provide an alternative life-saving measure for patients with advanced end-stage heart failure. The mechanical circulatory support provided by LVAD may allow the left side of the heart to rest and recover enough so that removal of the device is possible and a heart transplant is no longer needed, at least temporarily. However, more research in this area is needed. Using data collected from patients who have undergone LVAD implantation, this study will attempt to better assess heart recovery and to generate criteria for identifying patients eligible for the removal of LVAD support.

Participation in this study will last up to 3 years. First, 3 months before LVAD implantation, participants' medical records, including their medical history, medical therapy, and cardiac testing, will be obtained. Next, participants will undergo a weaning echocardiogram (echo) 1 month after LVAD implantation and, if necessary, monthly for 2 more months.During the weaning echoes, participants will have their LVAD settings adjusted, condition monitored, and additional data concerning their status collected. Before each echo, participants will also undergo a blood draw to determine how much blood thinner they will receive, if necessary.

12cc of blood will be collected up to 30 days prior to the VAD implant to look at gene expression and proteins expressed in your white blood cells and blood serum.

During the surgery, a small piece of tissue, ranging in the size from 1/4 inch cubed to 1 inch cubed will be removed from the heart tissue. The surgeon removes the heart tissue as part of the normal surgical process, so that the surgeon can implant the VAD. Approximately half of the tissue will then be stored for research purposes.

2-6 weeks after surgery a second blood draw of 12cc will be drawn again to look at the gene expression and proteins expressed in the patient's white blood cells and blood serum.

Participants who are not eligible to be weaned from LVAD support after the three weaning echoes will continue to be monitored every 6 months for up to 3 years or until the device is removed. Participants who are eligible to have the LVAD removed will undergo another echo after they have recovered from the surgery and are no longer taking any intravenous medications to help the heart. Data from any routine follow-up echoes will also be collected from these participants every 6 months until study completion at Year 3.

If the patient's heart recovers and the LVAD is removed, we are interested in removing a second piece of heart tissue that would otherwise be discarded at the time of removal of the LVAD.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study will include participants who have undergone or are about to undergo LVAD implantation at one of the three participating clinical centers.

Criteria

Inclusion Criteria:

  • Eligible to receive an LVAD or biventricular assist device (BIVAD) for clinical indications.

Exclusion Criteria:

  • Refuses LVAD support
  • Requires right ventricular assist device (RVAD) placement alone
  • In atrial fibrillation with a ventricular response of greater than 120 beats per minute
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687856

Contacts
Contact: John Gorcsan, MD 412-647-6570 gorcsanj@upmc.edu
Contact: Jessica Pisarcik, BSN, RN 412-647-4463 pisarcikje2@upmc.edu

Locations
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Cindy Young    410-328-2750    CYoung@smail.umaryland.edu   
Principal Investigator: Bartley Griffith, Griffith, M.D.         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Lydia McGowan    734-647-7958    lydiamcg@umich.edu   
Principal Investigator: Keith Aaronson, MD         
United States, Oklahoma
INTEGRIS Baptist Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Neela Chelikani       Neela.Chelikani@Integris-Health.com   
Principal Investigator: Douglas Horstmanshof, MD         
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Active, not recruiting
Hershey, Pennsylvania, United States, 17033
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jessica Pisarcik, BSN, RN    412-647-4463    pisarcikje2@upmc.edu   
Principal Investigator: John Gorcsan, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: John Gorcsan, MD UPMC University of Pittsburgh
  More Information

No publications provided

Responsible Party: John Gorcsan, National Prinicipal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00687856     History of Changes
Other Study ID Numbers: 585, 1 R01 HL086918-01A1
Study First Received: May 29, 2008
Last Updated: March 13, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Left Ventricular Assist Device

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014