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This study will evaluate how the cardiovascular system interacts with mechanical hearts to provide blood flow to the body during exercise. Two aims are proposed: 1) to determine the impact of a mechanical heart on exercise pressor reflexes in heart failure patients; and 2) to define the primary determinant(s) of exercise capacity in heart failure patients before and after device implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Heart Failure | 40 patients with advanced heart failure scheduled to undergo Left Ventricular Assist Device (LVAD) insertion will be recruited for testing. Test subjects will complete testing prior to, and following LVAD implantation. | ||
| Healthy controls | 10 age-matched healthy individuals will be recruited to establish normal/reference values. | ||
| Mild Heart Failure | A second control group comprised of 10 age-matched individuals will be recruited to establish normal/reference values for individuals with mild, medically managed heart failure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in the sympathetic neural response. | The primary outcome will be the difference in the muscle sympathetic neural response (MSNA) to handgrip and post-exercise circulatory arrest (PECA) before and after Continuous-flow left ventricular assist device (CF-LVAD) insertion | 4 weeks prior to implantation and 6 months post implantation. |
| Change in VO2. | The primary outcome will be the change in the VO2 (maximum rate of oxygen consumption) before and after CF-LVAD insertion. | 4 weeks prior to implantation and 6 months post implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the hemodynamic response. | This outcome will evaluate any difference in the hemodynamic response (heart rate and blood pressure) to handgrip and PECA before and after CF-LVAD | 4 weeks prior to implantation and 6 months post implantation. |
| VO2 relationship and ventilatory threshold (1) |
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Advanced Heart Failure-
Inclusion Criteria:
Exclusion Criteria:
Mild Heart Failure -
Inclusion Criteria:
Exclusion Criteria:
Healthy Controls -
Inclusion Criteria:
- Persons without a past medical history of cardiovascular disease or related disease (e.g. hypertension, diabetes, peripheral vascular disease, arrhythmias, stroke/transient ischemic attack) and are not taking any cardiac-related medications (e.g. antihypertensive medications)
Exclusion Criteria:
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40 - HF patients with advanced heart failure who are scheduled to undergo LVAD insertion (Advanced Heart Failure)
10 - HF patients with mild heart failure who are not scheduled to undergo LVAD insertion, to serve as first control group (Mild Heart Failure)
10 - Age-matched healthy individuals, with no past medical history, to serve as a second control group (Healthy Controls)
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| Name | Affiliation | Role |
|---|---|---|
| William K Cornwell, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Snschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37632493 | Derived | Buchanan C, Buchanan C, Riordan M, Byrd J, Schulte M, Kohrt WM, Ambardekar AV, Allen LA, Wolfel G, Lawley J, Levine BD, Cornwell WK 3rd. Cardiopulmonary Performance Among Heart Failure Patients Before and After Left Ventricular Assist Device Implantation. JACC Heart Fail. 2024 Jan;12(1):117-129. doi: 10.1016/j.jchf.2023.06.017. Epub 2023 Aug 23. | |
| 36871613 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 31, 2025 | |
| Reset | Feb 21, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 31, 2025 | Feb 21, 2025 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Approximately 20cc of blood will be collected during testing.
Cardiac output (Qc): VO2 relationship and ventilatory threshold before and after CF-LVAD insertion. |
| 4 weeks prior to implantation and 6 months post implantation. |
| VO2 relationship and ventilatory threshold (2). | Determinants of Qc after CF-LVAD insertion (ie, contribution from device v. contribution from left ventricle). | 4 weeks prior to implantation and 6 months post implantation. |
| VO2 relationship and ventilatory threshold (3). | Qc, VO2, ventilatory threshold and exercise capacity at increased pump speed. | 4 weeks prior to implantation and 6 months post implantation. |
| VO2 relationship and ventilatory threshold (4). | Bloodflow to the periphery, as measured by transcranial Doppler to assess brain bloodflow during exercise/activity. | 4 weeks prior to implantation and 6 months post implantation. |
| Oxygen uptake and utilization | Cerebral and musculoskeletal oxygen uptake by near-infrared spectroscopy | 4 weeks prior to implantation and 6 months post implantation. |
| Edward JA, Parker H, Stohr EJ, McDonnell BJ, O'Gean K, Schulte M, Lawley JS, Cornwell WK 3rd. Exertional Cardiac and Pulmonary Vascular Hemodynamics in Patients With Heart Failure With Reduced Ejection Fraction. J Card Fail. 2023 Sep;29(9):1276-1284. doi: 10.1016/j.cardfail.2023.01.010. Epub 2023 Mar 5. |
| 33464953 | Derived | Sailer C, Edelmann H, Buchanan C, Giro P, Babcock M, Swanson C, Spotts M, Schulte M, Pratt-Cordova A, Coe G, Beindorff M, Page RL 2nd, Ambardekar AV, Pal JD, Kohrt W, Wolfel E, Lawley JS, Tarumi T, Cornwell WK 3rd. Impairments in Blood Pressure Regulation and Cardiac Baroreceptor Sensitivity Among Patients With Heart Failure Supported With Continuous-Flow Left Ventricular Assist Devices. Circ Heart Fail. 2021 Jan;14(1):e007448. doi: 10.1161/CIRCHEARTFAILURE.120.007448. Epub 2021 Jan 19. |