Long-Term Survival After LVAD Implantation in End-Stage Heart Failure

Официальное название

Long-Term Survival After Left Ventricular Assist Device Support (LVAD) Implantation in Patients With End-Stage Heart Failure: A Prospective, Observational, Multi-Center Cohort Study

Обзор

This is a prospective, observational, multi-center cohort study designed to evaluate long-term survival and clinical outcomes in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation. Patients receiving LVAD implantation as part of routine clinical care will be enrolled and followed for up to 3-5 years. During the study period, data will be collected on baseline characteristics, preoperative medical therapy, intraoperative surgical information, in-hospital course, and long-term postoperative medication use, as well as survival status, major clinical outcomes, LVAD-related complications, and hospital readmissions. In addition, myocardial tissue samples will be obtained from the left ventricular apex during LVAD implantation surgery. These tissue samples are routinely removed as part of the standard surgical procedure and would otherwise be discarded after pathological examination. Peripheral blood samples will also be collected at predefined time points as part of routine clinical blood testing. No additional surgical procedures or invasive interventions are required for this study. This study does not involve any experimental treatment or changes to standard medical care. All treatments and follow-up assessments are determined by the treating physicians according to routine clinical practice. The purpose of this study is to improve understanding of long-term outcomes after LVAD implantation and to explore potential biological factors associated with prognosis in patients with end-stage heart failure.

Вмешательства

• Другое Left Ventricular Assist Device (LVAD) implantation
  Left ventricular assist device (LVAD) implantation performed as part of routine clinical care for patients with end-stage heart failure. This study is observational in nature and does not assign, alter, or mandate any intervention. The decision to implant an LVAD, the type of device used, perioperative management, and postoperative treatment are determined solely by the treating clinical team according to standard clinical practice.

Первичные конечные точки

• Clinical response after LVAD implantation [Срок оценки: During longitudinal follow-up up to 5 years after LVAD implantation]

Вторичные конечные точки (1)

• Genetic and molecular correlates of clinical response after LVAD implantation [Срок оценки: Assessed during follow-up up to 3-5 years after LVAD implantation]

Критерии участия

Критерии включения

• Adults aged ≥18 years
• Diagnosis of end-stage heart failure refractory to optimal medical therapy
• Scheduled to undergo left ventricular assist device (LVAD) implantation as part of routine clinical care
• Able to provide written informed consent for participation and biospecimen collection
• Willing and able to comply with study procedures and long-term follow-up
• Availability of left ventricular apical myocardial tissue obtained during LVAD implantation surgery
• Availability of peripheral blood samples collected during routine clinical care
• Patients treated at participating study centers

Критерии исключения

• Age <18 years
• Prior implantation of a durable mechanical circulatory support device
• Concomitant heart transplantation at the time of index surgery
• Congenital heart disease requiring complex surgical repair
• Active systemic infection or sepsis at the time of LVAD implantation
• Known active malignancy with a life expectancy <1 year
• Severe non-cardiac comorbidities limiting expected survival to less than 1 year (e.g., advanced liver failure, end-stage renal disease not eligible for renal replacement therapy)
• Inability or unwillingness to provide informed consent
• Pregnancy or breastfeeding at the time of enrollment
• Inadequate quantity or quality of myocardial tissue or peripheral blood samples for planned analyses

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• +86 025 83106666 — Нанкин

Публикации

• Drakos SG, Badolia R, Makaju A, Kyriakopoulos CP, Wever-Pinzon O, Tracy CM, Bakhtina A, Bia R, Parnell T, Taleb I, Ramadurai DKA, Navankasattusas S, Dranow E, Hanff TC, Tseliou E, Shankar TS, Visker J, Hamouche R, Stauder EL, Caine WT, Alharethi R, Selzman CH, Franklin S. Distinct Transcriptomic and Proteomic Profile Specifies Patients Who Have Heart Failure With Potential of Myocardial Recovery o PMID 36448446

Идентификаторы

NCT: NCT07382284 · 2024-577-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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