Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender Specific Differences in 170 Patients Undergoing Aortic Valve Replacement Surgery (SALVAGE)

January 23, 2023 updated by: Lisa Gundestrup

Aortic Stenosis Associated Left Ventricular Remodeling - Impact of Genetic, Valvular and Non-valvular Factors

The goal of this study is to investigate the genetic and gender specific differences, in patients with low flow low gradient aortic stenosis and high flow high gradient aortic stenosis. Patients referred for surgical aorticvalve replacement will be offered to participarte in the study.

The main questions the study aims to answer are:

  1. Low-gradient aortic stenosis is associated with differences in valvular concentration of the genes that code for mast-cell chymase, Angiotensin-II, ACE, ACE2 and Angiotensin receptor 1 and 2.
  2. Low-gradient aortic stenosis is associated with differences in the genetic code of renin-angiotensin-aldosterone system.
  3. Gender differences in LV remodelling associates with different levels of sexual hormones.

Patients participating in the study will be asked to undergo:

  • Cardiac ultrasound, MR- and CT-scan prior to surgery
  • Blooddraw prior to surgery.
  • Heartmuscle biopsy during surgery
  • Cardiac MR-scan 1 year after surgery.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients referred for surgical aortic valve replacement at the department of Cardiothoracic and vascular surgery at Odense University Hospital, Denmark will be evaluated and if they meet the inclusion criteria they will be invited to participate in the study.

Description

Inclusion Criteria:

  1. Severe AS (estimated by the local heart team, aortic valve area<1cm2) referred for AVR at the cardiology department at Odense University Hospital
  2. Age > 18 years
  3. Signed informed consent

Exclusion Criteria:

  1. Bicuspid aortic valve.
  2. LV systolic dysfunction (LVEF<50%).
  3. Patients with concomitant moderate-severe aortic valve regurgitation.
  4. Concomitant moderate-severe mitral valve regurgitation.
  5. Moderate to severe nephropathy (s-creatinine >200 mmol/l)
  6. Unwilling to participate in the study.
  7. Claustrophobia.
  8. Permanent cardiac devices (pacemaker and ICD)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Genetic polymorphisms betweem low flow low gradient and high flow high gradient aortic stenosis patients
Time Frame: At the time of surgery
At the time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lisa Gundestrup

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

January 31, 2025

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Estimate)

January 24, 2023

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SALVAGE protocol version 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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