Identifying and Facilitating Ventricular Recovery on Mechanical Support

NCT00687856 | Completed Results DMC

• 2 other identifiers: 585R01HL086918
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Heart Failure

Keywords

Left Ventricular Assist Device

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Left Ventricular Recovery and LVAD Explant

  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.

  Number of participants who had LV recovery and LVAD explant over 3 years.

Secondary Outcomes (1)

• Refine and Test Feedback Control Algorithm That Allows Precise Prescription of Cardiac Loading Through Synchronized and Asynchronized LVAD Operation With Native Left Ventricular Contraction

  Measured at Year 3

Study Arms (1)

LVAD Recipients

Participants who have had or are about to have a left ventricular assist device (LVAD) implanted

Procedure: Echocardiogram (echo)

Interventions

Echocardiogram (echo) PROCEDURE

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.

LVAD Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Caves

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Geological Phenomena; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Results Point of Contact

• Title: John Gorcsan MD
• Organization: University of Pittsburgh

gorcsanj@upmc.edu

4126476570

Study Officials

• John Gorcsan, MD

  UPMC University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 2, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 16, 2023
• Results First Posted: February 11, 2016

Record last verified: 2017-06

Locations

US (5)