ROBIN: InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's
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
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
- Peak Vo2 [20 minutes]
peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing
- Cardiac Output [20 minutes]
cardiac output measured during invasive cardiopulmonary exercise testing.
Secondary Outcome Measures
- Blood Pressure [20 minutes]
mean arterial pressure during exercise
- Respiratory Exchange Ratio [20 minutes]
Respiratory exchange ratio derived from indirect calorimetry
- Minute Ventilation [20 minutes]
Minute ventilation during cardiopulmonary exercise testing
- Tau [20 minutes]
unit of measure of diastolic function during exercise
- Stroke Work [20 minutes]
stroke work during exercise
- EES/EA [20 minutes]
ventricular arterial coupling during exercise
Eligibility Criteria
Criteria
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:
-
Have already received CF-LVADs and are clinically stable,
-
Ambulatory outpatients and are fully recovered (at least 3 months) from LVAD implantation;
Exclusion criteria:
-
Individuals with clinical right ventricular (RV) failure under resting conditions, defined as moderate-severely reduced RV systolic function on echocardiography, or
-
Clinical evidence of RV failure (elevated jugular venous pressures, 3 or 4+ [significant] peripheral edema);
-
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:
- Persons without a past medical history of cardiovascular disease or related disease such as:
-
hypertension,
-
diabetes,
-
peripheral vascular disease,
-
arrhythmias,
- are not taking any cardiac-related medications (e.g. antihypertensive medications).
Exclusion criteria:
-
Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC");
-
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
- Cornwell WK, Tran T, Cerbin L, Coe G, Muralidhar A, Hunter K, Altman N, Ambardekar AV, Tompkins C, Zipse M, Schulte M, O'Gean K, Ostertag M, Hoffman J, Pal JD, Lawley JS, Levine BD, Wolfel E, Kohrt WM, Buttrick P. New insights into resting and exertional right ventricular performance in the healthy heart through real-time pressure-volume analysis. J Physiol. 2020 Jul;598(13):2575-2587. doi: 10.1113/JP279759. Epub 2020 May 18.
- Tran T, Muralidhar A, Hunter K, Buchanan C, Coe G, Hieda M, Tompkins C, Zipse M, Spotts MJ, Laing SG, Fosmark K, Hoffman J, Ambardekar AV, Wolfel EE, Lawley J, Levine B, Kohrt WM, Pal J, Cornwell WK 3rd. Right ventricular function and cardiopulmonary performance among patients with heart failure supported by durable mechanical circulatory support devices. J Heart Lung Transplant. 2021 Feb;40(2):128-137. doi: 10.1016/j.healun.2020.11.009. Epub 2020 Nov 22.
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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
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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
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 |
william.cornwell@ucdenver.edu |
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