Aortic Valve StenosisSALVAGENCT05696145
Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender Specific Differences in 170 Patients Undergoing Aortic Valve Replacement Surgery
An observational study of Aortic Valve Stenosis, run by Lisa Gundestrup.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 31 Jan 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
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.
Who may be able to join
- Severe AS (estimated by the local heart team, aortic valve area<1cm2) referred for AVR at the cardiology department at Odense University Hospital
- Age > 18 years
- Signed informed consent
Who cannot join
- Bicuspid aortic valve.
- LV systolic dysfunction (LVEF<50%).
- Patients with concomitant moderate-severe aortic valve regurgitation.
- Concomitant moderate-severe mitral valve regurgitation.
- Moderate to severe nephropathy (s-creatinine >200 mmol/l)
- Unwilling to participate in the study.
- Claustrophobia.
- Permanent cardiac devices (pacemaker and ICD)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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:
Read more
- 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.
- Low-gradient aortic stenosis is associated with differences in the genetic code of renin-angiotensin-aldosterone system.
- 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.
- Conditions
- Aortic Valve Stenosis
- Keywords
- low flow low gradient aortic valve stenosis
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic polymorphisms betweem low flow low gradient and high flow high gradient aortic stenosis patients
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve 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.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Lisa Gundestrup
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lisa Gundestrup, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696145
- Sponsor's protocol ID
- SALVAGE protocol version 1
- Acronym
- SALVAGE
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Stenosis Associated Left Ventricular Remodeling - Impact of Genetic, Valvular and Non-valvular Factors
- ClinicalTrials.gov ID
- NCT05696145
- Acronym / sponsor ID
- SALVAGE / SALVAGE protocol version 1
- Conditions
- Aortic Valve Stenosis
- Keywords
- low flow low gradient aortic valve stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Lisa GundestrupUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Low-gradient aortic stenosis is associated with differences in the genetic code of renin-angiotensin-aldosterone system.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Severe AS (estimated by the local heart team, aortic valve area<1cm2) referred for AVR at the cardiology department at Odense University Hospital
- Age > 18 years
- Signed informed consent
Key exclusion criteria (8 listed)
- Bicuspid aortic valve.
- LV systolic dysfunction (LVEF<50%).
- Patients with concomitant moderate-severe aortic valve regurgitation.
- Concomitant moderate-severe mitral valve regurgitation.
- Moderate to severe nephropathy (s-creatinine >200 mmol/l)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic polymorphisms betweem low flow low gradient and high flow high gradient aortic stenosis patients
Time frame: At the time of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Lisa Gundestrup.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Gundestrup, MD (+4530563464, lisa.gundestrup@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic polymorphisms betweem low flow low gradient and high flow high gradient aortic stenosis patients (time frame: At the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2023.