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Identification of Genetic Causes of Calcific Aortic Valve Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04149600
Recruitment Status : Suspended (Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval)
First Posted : November 4, 2019
Last Update Posted : May 6, 2020
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center

Brief Summary:
This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.

Condition or disease Intervention/treatment
Calcific Aortic Stenosis Calcific Aortic Stenosis - Bicuspid Valve Aortic Valve Disease Aortic Valve Calcification Aortic Diseases Aortic Aneurysm Aortic Valve Cusp Abnormality Aortic Valve Disease Mixed Aortic Valve Insufficiency Procedure: Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Genetic Causes of Calcific Aortic Valve Disease
Actual Study Start Date : September 25, 2018
Estimated Primary Completion Date : June 30, 2027
Estimated Study Completion Date : June 30, 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Bicuspid aortic valve
We wish to investigate the etiology of calcific aortic valve disease, and aortic dilation or aneurysm in patients with a bicuspid aortic valve undergoing aortic valve replacement or aortic surgery.
Procedure: Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.
Adult patients undergoing aortic valve replacement (AVR) and/or aortic resection will be enrolled.

Tricuspid aortic valve
Data and samples will be compared using a control group comprised of patients with a tricuspid aortic valve undergoing aortic surgery.
Procedure: Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.
Adult patients undergoing aortic valve replacement (AVR) and/or aortic resection will be enrolled.




Primary Outcome Measures :
  1. Identification of expression signatures of aortic valve development and calcification in the macroscopically normal and abnormal portions of aortic valves excised during aortic valve replacement. [ Time Frame: 8 years ]

    We will take a portion of the aortic valve and/or aortic tissue that is routinely excised for aortic valve or aortic replacement for expression analyses and generation of fibroblast cell lines. In collaboration with the Department of Pathology, we have established methods to take sufficient "normal" and abnormal tissue while allowing formal routine pathological evaluation.

    All tissue samples for expression analysis will be transported in iced RNALater and later frozen in a -80°C research freezer, prior to next generation sequencing. We may use tissue samples to develop cell lines for indefinite use.



Biospecimen Retention:   Samples With DNA
Broadly, in order to perform the study, we will collect DNA for genotyping and "discarded" aortic valve and aortic tissue.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The investigators wish to identify the molecular genetic causes of the variability in development of calcific aortic valve disease and aortic dilation in patients with a plan to undergo elective aortic valve replacement and/or ascending aortic surgery at BIDMC.
Criteria

Inclusion Criteria:

  • Patients with a plan to undergo elective aortic valve replacement and/or ascending aortic surgery

Exclusion Criteria:

  • Age < 20 years
  • Unable/unwilling to consent
  • History of aortic valve replacement or transcatheter aortic valve replacement (TAVR)
  • History of endocarditis
  • History of rheumatic fever
  • History of chest radiotherapy
  • History of organ transplant

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): NCT04149600


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
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Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04149600    
Other Study ID Numbers: 2018P000380
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Valve Stenosis
Heart Defects, Congenital
Heart Valve Diseases
Aortic Diseases
Aortic Valve Insufficiency
Calcinosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases
Ventricular Outflow Obstruction
Calcium Metabolism Disorders
Metabolic Diseases
Cardiovascular Abnormalities