AzTrials
AzTrials

End-stage Heart FailureIMPULSMACSNCT04951999

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

A study testing Blood sampling in people with End-stage Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End-stage Heart Failure
What is being tested?
Blood sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteFrance
Study dates
2 Dec 2021to 24 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Ongoing participation in another intervention research protocol except LEVOECMO project (NCT04728932) and ANCHOR project (NCT04184635)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupement Hospitalier pitié Salpêtrière

    Paris, 75013

Other trials in France

About this study

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.

Read the 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).

Being tested
Blood sampling
Keywords
LVAD, pulsatility index, Von Willebrand Factor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplingOther

    For 10 visits (out of the 12 of the protocol), ~40 ml of blood is sampled for research purposes in addition to care sampling.

Study groups in NCT04951999
Study groupRoleWhat they receive
Blood samplingOtherNot described
Receives: Other: Blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Von Willebrand factor high molecular weight multimers (HMWM) ratio

    Comparison of Von Willebrand factor high molecular weight multimers (HMWM) ratio at LVAD pre-implantation and at day 30.

    Measure of an correlation between preserved pulsatility and the HMWM ratio evolution during the first month after implantation.

    Measured: 30 days after LVAD IMPLANTATION

Secondary outcomes (10)

  1. Severe postoperative gastrointestinal bleeding

    Track record of patients undergoing gastrointestinal bleeding, identified by a decreased hemoglobin level associated with chronic iron deficiency anemia of unexplained cause and melena or bleeding demonstrated by exploration of the gastrointestinal tract by esophageal endoscopy, colonoscopy, or endoscopic videoscopy and resulting in any of the following:

    • Death
    • Re-operation
    • Hospitalization
    • An erythrocyte transfusion defined as:
    • Within 7 days of implantation :
    • Patients weighing 50 kg or more: ≥ 4U of packed red blood cells in a 24-hour period.
    • Patients weighing less than 50 kg: ≥ 20 mL/kg of packed red blood cells over a 24-hour period
    • After 7 days post-implantation : any transfusion of packed red blood cells.

    Measured: 6 months

  2. Post-operative right ventricular failure

    Track record of patients undergoing right ventricular failure, identified by:

    • Elevation of central venous pressure (CVP) >16 mmHg by direct or echocardiographic measurement (inferior vena cava diameter >20 mm and respiratory variations <50%) for more than 48 hours
    • and at least one of the following signs of hemodynamic failure persisting for more than 48 hours:
    • Increased inotropic score
    • Hyperlactatemia >3 mmol/l
    • Hepatic cytolysis: increase in AST and/or ALT by a factor of 3 or more after implantation
    • Degradation of renal function (AKIN grade 2: creatinine elevation > 50% compared with before explantation and diuresis < 0.5 ml/kg/24h for 12 hours)
    • Implantation of right temporary circulatory support (ECMO)

    Measured: 6 months

  3. Platelet dysfunction

    Platelet dysfunction defined by a significant increase in circulating levels of p-selectin and glycocalicin between pre- and post-implantation

    Measured: 6 months

  4. Post-operative transient or permanent ischemic attack

    Track record of patients undergoing ischemic attack (between 24 hours and 6 months post-operative) as assessed per INTERMACS definition

    Measured: 6 months

  5. Vascular endothelium dysfunction

    Vascular endothelial dysfunction defined by a significant increase in circulating levels of syndecan, thrombomodulin, TFPI and PAI-1 between pre- and post-implantation

    Measured: 6 months

  6. Prolonged systemic inflammatory reaction syndrome

    Monthly measures of following circulating inflammatory factors : TNFα et β, NF kappab, TGF α /β1/β2,IFNγ et β, IL-1β, IL-1RA, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p40, IL12-P70, IL-17, IL17A et F,CX3CL1 (fractalkine),MCP-1(CCL2), MIP-1 (CCL3), MIP-1β(CCL4), MIP-3-beta (CCL19), 6Ckine(CCL21), MCD (CCL22) Myostatin, calveolin-1.

    Measured: 6 months

  7. Evolution of immune responses

    Monthly phenotyping of monocytes and T cells

    Measured: 6 months

  8. Aortic valve fusion

    Monthly echographic evaluation

    Measured: 6 months

  9. Aortic valve insufficiency

    Monthly echographic evaluation

    Measured: 6 months

  10. Evaluation of cardiac recovery

    Monthly exercise stress test evaluation (starting 2 months post-operative)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2021
  2. Study start2 Dec 2021
  3. Primary completion24 Jul 2024
  4. Study completion24 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04951999
Sponsor's protocol ID
APHP190830
Other IDs
2020-A01450-39
Acronym
IMPULSMACS
Status last verified
Aug 2025
First submitted
14 Jun 2021
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Questions about this trial

What is this clinical trial studying?

A study testing Blood sampling in people with End-stage Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Von Willebrand factor high molecular weight multimers (HMWM) ratio (time frame: 30 days after LVAD IMPLANTATION). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04951999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in