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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: End-stage Heart Failure

Treatments: Other: Blood sampling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04951999

2020-A01450-39 (Other Identifier)

APHP190830

Details and patient eligibility

About

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.

Full 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).

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients over 18 years of age
2. 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).
3. Patients affiliated to a social security system (beneficiaries or beneficiaries entitled to benefits, excluding AME)
4. 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

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Blood sampling

Other group

Treatment:

Other: Blood sampling