Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life (Ramp-it-Up)

April 8, 2019 updated by: University of Chicago

Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life: A Multicenter Study

The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp Tests to determine which method of testing provides better information for adjusting pump speed and medical treatment for Left Ventricular Assist Device (LVAD) patients. Better adjustments may provide better quality of life, exercise tolerance and reduced unwanted cardiac events over a 6-month period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All Left Ventricular Assist Device (LVAD)patients undergo testing to determine the best pumping speed for their Left Ventricular Assist Device (LVAD) and to gather measurements that help guide medical treatment. The testing uses echocardiography ("echo", ultrasound images of the heart) to create heart images and make measurements while gradually increasing the Left Ventricular Assist Device (LVAD) heart pump speed. Each time the pump speed is increased, images and measurements are taken. This is called a ramp test.

The ramp testing may also be performed during a right heart catheterization procedure. In a catheterization procedure, a doctor inserts a thin, flexible tube (catheter) into a vein or artery in the upper leg (groin), arm or neck and guides it to the heart using X-ray imaging. Doctors normally perform this procedure to measure the pressure and blood flow in the heart (otherwise called hemodynamic measurements). If the ramp testing is performed during this procedure, then the doctors have additional measurements to consider before choosing a final speed for the Left Ventricular Assist Device (LVAD) pump and appropriate medical treatment.

All of the procedures in this study are considered standard of care. The research part is randomly assigning the subject to one of the two methods of testing in this study. Subjects have a 50/50 chance of being in either testing group.

Baseline Visit (1 - 3 months after Left Ventricular Assist Device (LVAD) implant)

The following will be performed:

  • Subjects will be asked to sign this consent form.
  • Physical exam with an assessment of heart failure symptoms, and medical history will be recorded
  • Routine blood tests (about 1 tablespoon will be drawn)
  • Subjects will be randomly assigned to one of the two testing groups. If there is time, the ramp test can be performed at this visit, but usually it will be scheduled to occur a different day in about 1 to 4 weeks.
  • 6 Minute Walk Test. This test measures how far the subject can walk in 6 minutes. If needed, this can be completed the day of the ramp test.
  • Subjects will be asked to complete a questionnaire about their current quality of life. This will take about 10 minutes. If needed, this can be completed the day of the ramp test.

Ramp Testing Groups:

  1. Echo Guided Testing - This testing uses echocardiography to create images of the heart and make measurements while gradually increasing the heart pump speed. The final pump speed and medical treatment are determined using the echo measurements. This will take about 45 minutes.

    OR

  2. Hemodynamic-Echo Ramp Testing - This testing is performed during a right heart catheterization procedure which provides hemodynamic measurements (pressure and blood flow) in addition to the echocardiography measurements. With this method, more echo images and measurements are taken. The final pump speed and medical treatment adjustments are made using the hemodynamic measurements as well as the information from the echo. This test will take about 1 hour and 45 minutes.

6 Months after Baseline Visit

The following will be performed:

  • Physical exam with an assessment of heart failure symptoms, and medical history will be recorded
  • Routine blood tests (about 1 tablespoon will be drawn)
  • 6 Minute Walk Test. This test measures how far the subject can walk in 6 minutes.
  • Subjects will be asked to complete a questionnaire about their current quality of life. This will take about 10 minutes.
  • All subjects will undergo a Hemodynamic-Echo Ramp Test at 6 months after the baseline visit.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States
        • UC San Diego Medical Center
      • Stanford, California, United States
        • Stanford Medical Center
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University
      • Chicago, Illinois, United States
        • The University of Chicago
    • New York
      • Bronx, New York, United States
        • Montefiore Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh Medical Center
    • Washington
      • Seattle, Washington, United States
        • University of Washington School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient older than 18 years
  2. Newly implanted HVAD
  3. HVAD support anticipated for at least 6 months
  4. Patient is ambulatory and discharged from hospital without inotropes
  5. Patient is between 1 and 3 months post implant
  6. Patient has not had a right heart catheterization since discharged from HVAD implantation hospitalization

Exclusion Criteria:

  1. The current HVAD is a replacement device
  2. Patients currently has Right Ventricle (RV) failure requiring home inotropes
  3. Inability to preformed right heart cath
  4. Inadequate echocardiographic windows

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1) Echo Guided Testing -
This testing uses echocardiography to create images of the heart and make measurements while gradually increasing the heart pump speed. The final pump speed and medical treatment are determined using the echo measurements. This will take about 45 minutes.
Procedure: Hemodynamic-Echo Ramp Testing -
Active Comparator: 2) Hemodynamic-Echo Ramp Testing -
This testing is performed during a right heart catheterization procedure which provides hemodynamic measurements (pressure and blood flow) in addition to the echocardiography measurements. With this method, more echo images and measurements are taken. The final pump speed and medical treatment adjustments are made using the hemodynamic measurements as well as the information from the echo. This test will take about 1 hour and 45 minutes.
Procedure: Echo Guided Testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical parameters most likely to be impacted by hemodynamic-echo ramp tests
Time Frame: 6 Months
6 Walk Test
6 Months
Heart Failure Readmission
Time Frame: 6 Months
Composite end-point of heart failure readmission.
6 Months
Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 6 Months
Kansas City Cardiomyopathy Questionnaire (KCCQ) a summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains in which scores are transformed to a range of 0-100.
6 Months
New York Heart Association (NYHA) Class
Time Frame: 6 Months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB15-1733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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