Clinical trial NCT04951999: AssocIation of PULSatility and Occurrence of Complications Related to Mechanically Assisted Circulatory Support
Official title: AssocIation of PULSatility and Occurrence of Complications Related to Mechanically Assisted Circulatory Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End-stage Heart Failure
Keywords: LVAD
pulsatility index
Von Willebrand Factor
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: ICAN Nutrition Education and Research
name: University Hospital, Lille
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2021-07-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Von Willebrand factor high molecular weight multimers (HMWM) ratio
timeFrame: 30 days after LVAD IMPLANTATION
Secondary outcomes:
measure: Severe postoperative gastrointestinal bleeding
timeFrame: 6 months
measure: Post-operative right ventricular failure
timeFrame: 6 months
measure: Platelet dysfunction
timeFrame: 6 months
measure: Post-operative transient or permanent ischemic attack
timeFrame: 6 months
measure: Vascular endothelium dysfunction
timeFrame: 6 months
measure: Prolonged systemic inflammatory reaction syndrome
timeFrame: 6 months
measure: Evolution of immune responses
timeFrame: 6 months
measure: Aortic valve fusion
timeFrame: 6 months
measure: Aortic valve insufficiency
timeFrame: 6 months
measure: Evaluation of cardiac recovery
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupement Hospitalier pitié Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Guillaume LEBRETON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: