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Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases

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ClinicalTrials.gov Identifier: NCT03279029
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

To investigate histological structure and molecular changes involved on the onset of AVD after left ventricular assist device (LVAD) implantation and to compare them with those of patients operated on for severe aortic regurgitation.

Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Patients operated on for severe aortic regurgitation are included as control. Clinical and TTE data are compiled. Samples of aortic valve are collected at the time of the intervention. RNA-sequencing analysis is performed in LVAD patients and variations of gene expression are validated by real time qPCR in both. Blood sampling are performed pre-operatively and at one-month follow up to assess the plasma level of previously identified gene modulators. In-vitro studies exposing VICs and VECs to several mechanical stimuli are performed for validation.

Conclusion(s) Taking together, the in-vivo and in-vitro models would provide important information for the understanding of valve remodeling and disease. ECM gene modulators could represent pertinent molecular targets to stop the progression of AVD


Condition or disease Intervention/treatment Phase
Aortic Valve Regurgitation Acquired Biological: blood samples Biological: biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patients with aortic valve disease (AVD). Biological: blood samples
blood samples

Biological: biopsy
biopsy of aortic valve

Experimental: patients with left ventricular assist device (LVAD Biological: blood samples
blood samples

Biological: biopsy
biopsy of aortic valve




Primary Outcome Measures :
  1. blood sample [ Time Frame: 24 months ]
    RNA-sequencing analysis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with long-term left-ventricular assistance awaiting transplant
  • Patients with severe aortic surgical spring deficiency
  • Major Patient

Exclusion Criteria:

  • Minor Patient
  • Pregnant or nursing women
  • Major under guardianship
  • People in emergencies
  • Persons not covered by the social security scheme

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279029


Contacts
Contact: alexis THERON alexis.theron@ap-hm.fr
Contact: JEAN OLIVIER ARNAUD 0491382747 drci@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: JEAN OLIVIER ARNAUD         
Principal Investigator: ALEXIS THERON         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: alexis THERON Assistance Publique Hopitaux De Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03279029     History of Changes
Other Study ID Numbers: 2017-08
2017-A00680-53 ( Other Identifier: idrcb )
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Aortic Valve Insufficiency
Cardiovascular Diseases