ROBIN: InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT03232736
Collaborator
(none)
22
1
28
0.8

Study Details

Study Description

Brief Summary

The primary reason the investigators are doing this study are to understand how the right side of the heart functions in heart failure patients with left ventricular assist devices (LVADs, or "mechanical hearts"). Second, the investigators are interested in understanding how different pacemaker settings influence function of the heart at rest and activity.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Healthy individuals, as well as patients with advanced heart failure supported by LVADs, completed invasive hemodynamic analysis at rest and with exercise to characterize right-sided heart function at rest and with exercise during invasive cardiopulmonary exercise testing on upright cycle ergometry.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    22 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Randomized interventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With mechaNical Circulatory Support Devices
    Actual Study Start Date :
    Oct 1, 2017
    Actual Primary Completion Date :
    Jan 30, 2020
    Actual Study Completion Date :
    Jan 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy Control

    Individuals free of cardiovascular disease and not on any medications to treat a cardiovascular-related condition

    LVAD Group

    Individuals with history of advanced heart failure who are supported by left ventricular assist devices

    Outcome Measures

    Primary Outcome Measures

    1. Peak Vo2 [20 minutes]

      peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing

    2. Cardiac Output [20 minutes]

      cardiac output measured during invasive cardiopulmonary exercise testing.

    Secondary Outcome Measures

    1. Blood Pressure [20 minutes]

      mean arterial pressure during exercise

    2. Respiratory Exchange Ratio [20 minutes]

      Respiratory exchange ratio derived from indirect calorimetry

    3. Minute Ventilation [20 minutes]

      Minute ventilation during cardiopulmonary exercise testing

    4. Tau [20 minutes]

      unit of measure of diastolic function during exercise

    5. Stroke Work [20 minutes]

      stroke work during exercise

    6. EES/EA [20 minutes]

      ventricular arterial coupling during exercise

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    15 patients with advanced heart failure (HF) who have already undergone implantation of a continuous-flow left ventricular assist device (CF-LVAD) implantation.

    Inclusion criteria:
    1. Have already received CF-LVADs and are clinically stable,

    2. Ambulatory outpatients and are fully recovered (at least 3 months) from LVAD implantation;

    Exclusion criteria:
    1. Individuals with clinical right ventricular (RV) failure under resting conditions, defined as moderate-severely reduced RV systolic function on echocardiography, or

    2. Clinical evidence of RV failure (elevated jugular venous pressures, 3 or 4+ [significant] peripheral edema);

    3. Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease); and

    10 healthy individuals will serve as a control group to define normal RV function during exercise.

    Inclusion criteria:
    1. Persons without a past medical history of cardiovascular disease or related disease such as:
    1. hypertension,

    2. diabetes,

    3. peripheral vascular disease,

    4. arrhythmias,

    1. are not taking any cardiac-related medications (e.g. antihypertensive medications).
    Exclusion criteria:
    1. Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC");

    2. Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Hospital Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: William Cornwell, MD, University of Colorado, Denver

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT03232736
    Other Study ID Numbers:
    • 17-1042
    First Posted:
    Jul 28, 2017
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Healthy Control LVAD Group w/Pacemaker
    Arm/Group Description healthy individuals free of cardiovascular disease and not on any cardiac-related medications, age > 18years. Pacemaker adjustments will be made to this group in blinded manner. Pacemaker adjustments: LVAD subjects with CRT device will have leads turned both on and off in blinded manner CRT: CRT device
    Period Title: Overall Study
    STARTED 9 13
    COMPLETED 9 13
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Healthy Control LVAD Group Total
    Arm/Group Description Healthy controls free of heart disease and not on any medications. Age 18+ years Heart failure patients supported by LVAD Total of all reporting groups
    Overall Participants 9 13 22
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    9
    100%
    9
    69.2%
    18
    81.8%
    >=65 years
    0
    0%
    4
    30.8%
    4
    18.2%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    42
    (12)
    61
    (9)
    52
    (14)
    Sex: Female, Male (Count of Participants)
    Female
    3
    33.3%
    1
    7.7%
    4
    18.2%
    Male
    6
    66.7%
    12
    92.3%
    18
    81.8%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    White
    9
    100%
    13
    100%
    22
    100%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    9
    100%
    13
    100%
    22
    100%

    Outcome Measures

    1. Primary Outcome
    Title Peak Vo2
    Description peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing
    Time Frame 20 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Healthy Control LVAD Group w/Pacemaker
    Arm/Group Description healthy people free of heart disease. heart failure patients supported by an LVD.
    Measure Participants 9 13
    Mean (Standard Deviation) [ml/kg/min]
    33
    (10.4)
    12.5
    (3.2)
    2. Primary Outcome
    Title Cardiac Output
    Description cardiac output measured during invasive cardiopulmonary exercise testing.
    Time Frame 20 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Healthy Control LVAD Group w/Pacemaker
    Arm/Group Description healthy people without cardiac disease heart failure patient supported by lvads.
    Measure Participants 9 13
    Mean (Standard Deviation) [L/min]
    18.4
    (7.3)
    9.1
    (3.3)
    3. Secondary Outcome
    Title Blood Pressure
    Description mean arterial pressure during exercise
    Time Frame 20 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Healthy Control LVAD Group
    Arm/Group Description Individuals free of cardiovascular disease and not on any medications to treat a cardiovascular-related condition Individuals with history of advanced heart failure who are supported by left ventricular assist devices
    Measure Participants 9 13
    Mean (Standard Deviation) [mmHg]
    119
    (7)
    91
    (10)
    4. Secondary Outcome
    Title Respiratory Exchange Ratio
    Description Respiratory exchange ratio derived from indirect calorimetry
    Time Frame 20 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Healthy Control LVAD Group w/Pacemaker
    Arm/Group Description healthy people free of heart disease. heart failure patients supported by an LVD.
    Measure Participants 9 13
    Mean (Standard Deviation) [ratio]
    1.08
    (0.08)
    0.03
    (0.08)
    5. Secondary Outcome
    Title Minute Ventilation
    Description Minute ventilation during cardiopulmonary exercise testing
    Time Frame 20 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Healthy Control LVAD Group w/Pacemaker
    Arm/Group Description healthy people free of heart disease. heart failure patients supported by an LVD.
    Measure Participants 9 13
    Mean (Standard Deviation) [L/min]
    102
    (40)
    56
    (19)
    6. Secondary Outcome
    Title Tau
    Description unit of measure of diastolic function during exercise
    Time Frame 20 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Healthy Control LVAD Group w/Pacemaker
    Arm/Group Description healthy people free of heart disease. heart failure patients supported by an LVD.
    Measure Participants 9 13
    Mean (Standard Deviation) [msec]
    25
    (6)
    54
    (49)
    7. Secondary Outcome
    Title Stroke Work
    Description stroke work during exercise
    Time Frame 20 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Healthy Control LVAD Group w/Pacemaker
    Arm/Group Description healthy people free of heart disease. heart failure patients supported by an LVD.
    Measure Participants 9 13
    Mean (Standard Deviation) [mmHg*mL]
    4999
    (2342)
    2455
    (783)
    8. Secondary Outcome
    Title EES/EA
    Description ventricular arterial coupling during exercise
    Time Frame 20 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Healthy Control LVAD Group w/Pacemaker
    Arm/Group Description healthy people free of heart disease. heart failure patients supported by an LVD.
    Measure Participants 9 13
    Mean (Standard Deviation) [ratio]
    1.6
    (0.8)
    1.40
    (0.34)

    Adverse Events

    Time Frame 8 Weeks
    Adverse Event Reporting Description
    Arm/Group Title Healthy Control LVAD Group w/Pacemaker
    Arm/Group Description healthy people free of heart disease. Heart failure patients supported by an LVAD.
    All Cause Mortality
    Healthy Control LVAD Group w/Pacemaker
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/9 (0%) 0/13 (0%)
    Serious Adverse Events
    Healthy Control LVAD Group w/Pacemaker
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/9 (0%) 0/13 (0%)
    Other (Not Including Serious) Adverse Events
    Healthy Control LVAD Group w/Pacemaker
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/9 (0%) 0/13 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title William Cornwell
    Organization University of Colorado Anschutz Medical Campus
    Phone 16142961686
    Email william.cornwell@ucdenver.edu
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT03232736
    Other Study ID Numbers:
    • 17-1042
    First Posted:
    Jul 28, 2017
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022