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Exercise capacity in continous-flow left ventricular assist device (CF-LVAD) patients remains severely reduced post-implant. While the effect of right ventricular (RV) failure early after pump implantation, and its effect on outcome has been extensively studied, the effects of late RV failure on exercise capacity and quality of life (QOL) has been sparsely described. Thus the purpose of this study is to examine RV function and the association to exercise capacity in CF-LVAD patients.
When pharmacological therapy becomes insufficient in advanced end-stage heart failure (HF) transplantation remains the gold standard of therapies. However, due to a severe lack of donor organs, mechanical circulatory support is an alternative option for some eligible patients. Mechanical circulatory support in the form of a CF-LVAD is a pump supporting the left ventricle by pumping blood from the apex to the ascending aortae. Implantation with a CF-LVAD increases survival and improves quality of life, but peak oxygen uptake (peak VO2) remains severely reduced post-implant. Complex central and peripheral hallmarks of heart failure attribute to the continued work intolerance. Furthermore a fixed CF-LVAD pump speed prevents adequate circulatory support during strenuous exercise. The effects of late right ventricular (RV) failure on exercise capacity and quality of life (QOL) is, however, unknown and the purpose of this study is to examine RV function and the association to exercise capacity in CF-LVAD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 arm study: CCT estimated right ventricular function. | Other | By use of Cardiac computed tomography, the ejection faction of the right ventricle will be visualized and measured in all participants. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Computed tomography | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Oxygen Uptake | Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Right Ventricular Function (RVEF) During Exercise | Right ventricular function during exercise was estimated by use of contrast enhanced cardiac computed tomography. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Rigshospitalet. | Copenhagen | 2100 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Arm Study: CCT Estimated Right Ventricular Function. | Fifteen patients with HeartMate (HM) II or III underwent echocardiography and maximal cardiopulmonary exercise test. Subsequently, contrast-enhanced 4D Cardiac Computed Tomography(CCT) scans were performed at rest and immediately after two minutes of supine 25 Watt ergometer bike exercise. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Arm Study: CCT Estimated Right Ventricular Function. | Cardiac Computed tomography |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 Oxygen Uptake | Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min. | Posted | Mean | Standard Deviation | ml/kg/min | Day 1 |
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Observed app. 1 hour after contrast infusion and > 30 min after each completed exercise test. No AE/SAE was observed.
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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 | 1 Arm Study: CCT Estimated Right Ventricular Function. | Fifteen patients with HeartMate (HM) II or 3 underwent echocardiography and maximal cardiopulmonary exercise test. Subsequently, contrast-enhanced four-dimensional (4D) cardiac computed tomography (CCT) scans were performed at rest and immediately after two minutes of supine 25 Watt ergometer bike exercise. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kiran Mirza | Rigshospitalet | 004535451442 | KMIR0003@regionh.dk |
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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 | Nov 14, 2021 | Nov 14, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Right Ventricular Function (RVEF) During Exercise | Right ventricular function during exercise was estimated by use of contrast enhanced cardiac computed tomography. | Posted | Mean | Standard Deviation | percent of ejected blood | Day 1 |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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