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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak Vo2 | peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing | 20 minutes |
| Cardiac Output | cardiac output measured during invasive cardiopulmonary exercise testing. | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | mean arterial pressure during exercise | 20 minutes |
| Respiratory Exchange Ratio | Respiratory exchange ratio derived from indirect calorimetry |
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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:
Exclusion criteria:
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:
f. are not taking any cardiac-related medications (e.g. antihypertensive medications).
Exclusion criteria:
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15 patients with advanced HF who have already undergone CF-LVAD implantation.
10 healthy individuals will serve as a control group to define normal RV function during exercise.
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| Name | Affiliation | Role |
|---|---|---|
| William Cornwell, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32347547 | Background | 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. | |
| 33281029 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Control | healthy individuals free of cardiovascular disease and not on any cardiac-related medications, age > 18years. |
| FG001 | LVAD Group w/Pacemaker | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Healthy individuals are those who are free of cardiovascular disease and not on any medications to treat a cardiovascular disease. Patients with LVADs are those with a history of advanced heart failure who are supported by an LVAD
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Control | Healthy controls free of heart disease and not on any medications. Age 18+ years |
| BG001 | LVAD Group | Heart failure patients supported by LVAD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Vo2 | peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing | Posted | Mean | Standard Deviation | ml/kg/min | 20 minutes |
|
|
8 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Control | healthy people free of heart disease. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Cornwell | University of Colorado Anschutz Medical Campus | 16142961686 | william.cornwell@ucdenver.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2019 | Jul 13, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 26, 2019 | Jun 11, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
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| 20 minutes |
| Minute Ventilation | Minute ventilation during cardiopulmonary exercise testing | 20 minutes |
| Tau | unit of measure of diastolic function during exercise | 20 minutes |
| Stroke Work | stroke work during exercise | 20 minutes |
| EES/EA | ventricular arterial coupling during exercise | 20 minutes |
| Background |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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|
|
| Primary | Cardiac Output | cardiac output measured during invasive cardiopulmonary exercise testing. | Posted | Mean | Standard Deviation | L/min | 20 minutes |
|
|
|
| Secondary | Blood Pressure | mean arterial pressure during exercise | Posted | Mean | Standard Deviation | mmHg | 20 minutes |
|
|
|
| Secondary | Respiratory Exchange Ratio | Respiratory exchange ratio derived from indirect calorimetry | Posted | Mean | Standard Deviation | ratio | 20 minutes |
|
|
|
| Secondary | Minute Ventilation | Minute ventilation during cardiopulmonary exercise testing | Posted | Mean | Standard Deviation | L/min | 20 minutes |
|
|
|
| Secondary | Tau | unit of measure of diastolic function during exercise | Posted | Mean | Standard Deviation | msec | 20 minutes |
|
|
|
| Secondary | Stroke Work | stroke work during exercise | Posted | Mean | Standard Deviation | mmHg*mL | 20 minutes |
|
|
|
| Secondary | EES/EA | ventricular arterial coupling during exercise | Posted | Mean | Standard Deviation | ratio | 20 minutes |
|
|
|
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | LVAD Group w/Pacemaker | Heart failure patients supported by an LVAD. | 0 | 13 | 0 | 13 | 0 | 13 |
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