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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05696145

Acronym

SALVAGE

Enrollment

170

Registered

2023-01-25

Start date

2023-03-01

Completion date

2025-01-31

Last updated

2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

low flow low gradient aortic valve stenosis

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Contacts

Primary ContactLisa Gundestrup, MD

lisa.gundestrup@rsyd.dk+4530563464

Outcome results