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Clinical Trials/NCT07633535
NCT07633535CompletedNot Applicable

Association of LVAD Index With Selected Hepatic and Renal Biochemical Markers and Rehospitalization in HVAD and HeartMate 3 Continuous-Flow Left Ventricular Assist Devices

Gaziantep City Hospital1 site in 1 country34 target enrollmentStarted: October 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
34
Locations
1

Study Overview

Brief Summary

This single-center, observational study evaluated the LVAD index, defined as device-estimated pump flow divided by body surface area, in adult patients supported with continuous-flow left ventricular assist devices. The study included 34 patients with end-stage heart failure who had either an HVAD or HeartMate 3 device and were followed for six months. The study assessed the relationship between LVAD index and selected routine biochemical markers related to hepatic and renal status, including ALT, AST, LDH, BUN, and creatinine. The study also evaluated whether LVAD index was associated with rehospitalization during follow-up.

Detailed Description

This observational cohort study included adult patients with end-stage heart failure supported with continuous-flow left ventricular assist devices. Patients with HVAD and HeartMate 3 devices were followed during routine clinical visits over a six-month period. Device-estimated pump flow, power consumption, and LVAD index were recorded at follow-up visits. LVAD index was calculated as device-estimated pump flow divided by body surface area. Routine laboratory parameters, including ALT, AST, LDH, BUN, and creatinine, were evaluated as selected biochemical markers related to hepatic and renal status and tissue injury. Rehospitalization status during follow-up was also assessed. The study did not assign participants to any intervention and did not include protocol-driven pump speed adjustment.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18 years or older
  • Diagnosis of end-stage heart failure
  • First-time continuous-flow left ventricular assist device implantation
  • Implanted with either an HVAD or HeartMate 3 left ventricular assist device
  • Minimum follow-up period of six months

Exclusion Criteria

  • Incomplete data
  • Declined participation
  • HeartMate II pump implantation
  • Significant aortic valve dysfunction, including moderate or severe aortic regurgitation or stenosis

Investigators

Sponsor
Gaziantep City Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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