AssocIation of PULSatility and Occurrence of Complications Related to Mechanically Assisted Circulatory Support (IMPULSMACS)

  • STATUS
    Recruiting
  • End date
    Jun 17, 2024
  • participants needed
    70
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 19 April 2022

Summary

The primary objective of this study is to determine whether preserved pulsatility for patients supported by CF-LVAD (continuous flow Left Ventricular Assist Device) is associated with less acquired deficiency of the Von Willebrand factor, a blood glycoprotein involved in hemostasis.

Description

Implantation of LVADs (Left Ventricular Assist Device) is a medium to long-term therapeutic option for patients with end-stage heart failure and isolated left ventricular dysfunction. Nevertheless, LVADs use remain limited by the frequency of their adverse effects, most of which being unpredictable. In the literature, loss of pulsatility seems to be associated with CF-LVADs complications, including bleeding. Accordingly, the primary objective of this study is to determine whether patient's preserved pulsatility is associated with less acquired deficiency of the Von Willebrand factor (VWF), a blood glycoprotein involved in hemostasis. This deficiency, characterized by a decrease or absence of VWF High Molecular Weight Multimers (HMWMs), is present to varying degrees in almost all patients with LVADs and is a major risk factor for bleeding complications in these patients. Pulsatility is estimated by the patient's blood pressure differential, measured 1) at discharge from the operating room (=transfer to care), 2) at discharge from care (=transfer to his or her room), 3) at discharge from the hospital (=transfer to rehabilitation), and then at each follow-up visit up to 6 months post-implantation. The primary endpoint is to determine whether a preserved pulsatility is associated with less acquired deficiency of the Von Willebrand factor ratio of High Molecular Weight Multimers (HMWMs).

Details
Condition End-stage Heart Failure
Treatment blood sampling
Clinical Study IdentifierNCT04951999
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients over 18 years of age
Patients for whom a decision to implant a left-sided monoventricular assist has been retained after discussion in the RCP of heart failure, transplantation and circulatory assistance (whatever the therapeutic strategy envisaged: waiting for transplantation, recovery or destination therapy)
Patients affiliated to a social security system (beneficiaries or beneficiaries entitled to benefits, excluding AME)
Signature of an informed consent by the patient or by the trusted person, or a close relative, if the patient is not able to do so

Exclusion Criteria

Ongoing participation in another intervention research protocol (except LEVOECMO project (NCT04728932) and ANCHOR project (NCT04184635)
Heart transplant patients
Patients who already had LVAD
Chronic renal failure patients on dialysis
Patients refusing to give informed consent
Patients deprived of liberty or under legal protection (guardianship, curators)
Pregnant or breastfeeding women
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