LVAD Index and Clinical Outcomes in Continuous-Flow LVAD Patients (LVAD-INDEX)
2. juni 2026 oppdatert av: Gaziantep City Hospital
Association of LVAD Index With Selected Hepatic and Renal Biochemical Markers and Rehospitalization in HVAD and HeartMate 3 Continuous-Flow Left Ventricular Assist Devices
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
34
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Antalya, Tyrkia (Türkiye), 07070
- Akdeniz University Faculty of Medicine
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adult patients with end-stage heart failure who underwent first-time continuous-flow left ventricular assist device implantation and were followed for at least six months.
The study population included patients supported with either HVAD or HeartMate 3 devices during routine clinical follow-up.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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HVAD Group
Patients supported with the HeartWare Ventricular Assist Device.
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Patients in this group were supported with the HeartWare Ventricular Assist Device as part of routine clinical care.
No device assignment or protocol-driven intervention was performed by the study investigators.
|
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HeartMate 3 Group
Patients supported with the HeartMate 3 left ventricular assist device.
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Patients in this group were supported with the HeartMate 3 left ventricular assist device as part of routine clinical care.
No device assignment or protocol-driven intervention was performed by the study investigators.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Association Between LVAD Index and Selected Biochemical Markers
Tidsramme: Six months
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The association between LVAD index and selected routine biochemical markers, including ALT, AST, LDH, BUN, and creatinine, was evaluated during six-month follow-up.
LVAD index was calculated as device-estimated pump flow divided by body surface area.
|
Six months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2022
Primær fullføring (Faktiske)
30. april 2023
Studiet fullført (Faktiske)
30. april 2023
Datoer for studieregistrering
Først innsendt
2. juni 2026
Først innsendt som oppfylte QC-kriteriene
2. juni 2026
Først lagt ut (Faktiske)
8. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- LVADIDX2022
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be publicly shared due to patient confidentiality and institutional data protection requirements.
De-identified data may be made available from the corresponding author upon reasonable request.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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