Identifying and Facilitating Ventricular Recovery on Mechanical Support (RECOVER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00687856|
Recruitment Status : Completed
First Posted : June 2, 2008
Results First Posted : February 11, 2016
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment|
|Heart Failure||Procedure: Echocardiogram (echo)|
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.
|Study Type :||Observational|
|Actual Enrollment :||211 participants|
|Official Title:||Identifying and Facilitating Ventricular Recovery on Mechanical Support|
|Study Start Date :||April 2008|
|Primary Completion Date :||July 2014|
|Study Completion Date :||July 2014|
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.
- Number of Subjects With Left Ventricular Recovery and LVAD Explant [ Time Frame: Number of participants who had LV recovery and LVAD explant over 3 years. ]Noninvasive determination of left ventricular function using novel echocardiographic imaging methods and routine clinical assessments to optimize markers of left ventricular recovery. These markers would determine LVAD patients with cardiac recovery who no longer needed LVAD support.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687856
|United States, Maryland|
|University of Maryland|
|Baltimore, Maryland, United States, 21201|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Oklahoma|
|INTEGRIS Baptist Medical Center|
|Oklahoma City, Oklahoma, United States, 73112|
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||John Gorcsan, MD||UPMC University of Pittsburgh|