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NCT04539093 · ClinicalTrials.gov registry record
Endothelial Function in Mechanical Circulatory Support
A clinical trial, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- 1
- Enrollment target
NCT04539093 is a clinical trial that has completed, run by Medical College of Wisconsin. The registered enrollment target is 1 participants.
The verdict
NCT04539093 has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- 1 participants
- Enrollment target
Study Summary
The pathophysiology of HF is highly variable, with overlapping pathogenic mechanisms that complicates any attempt to create a simple and unified conceptual model. Left ventricular (LV) ejection fraction (EF), assessed as the fraction of the end-diastolic volume that is ejected upon contraction, has been the cornerstone metric for characterization of LV systolic function in patients with HF. LVEF demonstrates a strong inverse relationship with clinical outcomes in HF in patients with reduced EF (HFrEF). Current management options for the treatment of HFrEF include medical management, mechanical circulatory support, and cardiac transplantation. In the setting of refractory end stage HFrEF, the standard of care is heart transplantation. Since limited organ procurement is a significant constraint to the treatment of patients with advanced disease, durable mechanical circulatory support (MCS) with left ventricular assist devices (LVAD) were developed as a safe and efficacious treatment strategy for patients with advanced HF that is refractory to medical therapy. The advances in LVAD engineering and design, tailored towards defined physiological goals, have resulted in the creation of much smaller continuous-flow (CF) pumps that possess technical superiority, pump durability, and ease of implantation compared to the older and larger pulsatile-flow pumps. The addition of speed modulation algorithms to the next generation centrifugal CF LVADs, has decreased the incidence of device related adverse events. Our interest lies in the impact of continuous flow hemodynamics on endothelial function and the cardiac and end-organ responses to this novel therapy. Current knowledge of the impact of these specific advances in LVAD therapy is however limited by the relative youth of the field. Thus, the goal of this research project is to study human LVAD patients and to determine the impact of speed modulation algorithms in CF physiology on microvascular and endothelial function and i
Interventions
- OTHER Exposure of interest - Use of left ventricular assist device (LVAD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2022-01-01 |
| Est. Completion | 2022-11-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04539093
The ClinicalTrials.gov registry entry for NCT04539093 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Exposure of interest - Use of left ventricular assist device (LVAD) is the first listed.
NCT04539093 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04539093 about?
NCT04539093 is a clinical study titled "Endothelial Function in Mechanical Circulatory Support". The pathophysiology of HF is highly variable, with overlapping pathogenic mechanisms that complicates any attempt to create a simple and unified conceptual model. Left ventricular (LV) ejection fraction (EF), assessed as the fraction of the end-diastolic volume that is ejected upon contraction, has ...
What is the current status of trial NCT04539093?
This trial is currently completed. The enrollment target is 1 participants. The study started on 2022-01-01. Estimated completion is 2022-11-11.
What interventions are being tested in trial NCT04539093?
The interventions under investigation include: Exposure of interest - Use of left ventricular assist device (LVAD) (OTHER).
Who is sponsoring clinical trial NCT04539093?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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