Identification of Genetic Causes of Calcific Aortic Valve Disease

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 20 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve, Aortic Valve Disease, Aortic Valve Calcification, Aortic Diseases, Aortic Aneurysm

Being tested

Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.

Medical subject headings

Aortic Valve, Calcification of, Aortic Valve Disease, Aortic Diseases, Aortic Aneurysm, Aortic Valve Insufficiency

What participants receive

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

• Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.Procedure or surgery

  Adult patients undergoing aortic valve replacement (AVR) and/or aortic resection will be enrolled.

What is being measured

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

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.

   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.

   Measured: 8 years

Timeline

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

1. First posted4 Nov 2019
2. Study start25 Sep 2018
3. Primary completion30 Jun 2027 (estimated)
4. Study completion30 Jun 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Calcific Aortic StenosisStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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