Status:
NOT_YET_RECRUITING
Involvement of the Gut Microbiota in Calcified Aortic Stenosis
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Aortic Stenosis
Gastrointestinal Microbiome
Eligibility:
All Genders
18-90 years
Brief Summary
Calcific aortic stenosis (CAS) is a disease characterized by progressive calcification of the aortic valve, obstructing the passage of blood from the left ventricle into the general circulation. It is...
Eligibility Criteria
Inclusion
- Group of patients with CAS:
- Calcified aortic stenosis diagnosed on a cardiac ultrasound or CT not older than 3 months
- Severe aortic stenosis: surgical indication based on symptoms and ultrasound data (high gradient aortic stenosis : Vmax\> 4m/s, mean gradient \> 40mmHg, area \< 1cm², low flow low-gradient CAS: left ventricular ejection fraction (LVEF) \< 40%, Vmax\< 4m/s, mean gradient \< 40mmHg, area \< 1cm², paradoxical low-gradient CAS: LVEF \> 55%, Vmax\< 4m/s, mean gradient \< 40mmHg, area \< 1cm²)
- Moderate CAS: 3m/s \<Vmax\< 4m/s, 20mmHg \< mean gradient \< 40mmHg
- Mild CAS: 2,6m/s \< Vmax \< 2.9m/s, mean gradient \< 20mmHg
- Aortic sclerosis: calcified remodeling of the aortic valve visible on ultrasound or CT.
- Control group - free of CAS:
- \- No calcified aortic stenosis verified on a cardiac ultrasound or CT not older than 3 months
Exclusion
- Treatment interfering with the composition of the intestinal microbiota: local or systemic corticosteroids within the last 3 months, antibiotics within the last 3 months, antiretrovirals, bile acid chelators (questran and colesevelam), HIV-targeted antiretroviral therapies, selective serotonin reuptake inhibitor-type antidepressants
- Clinical criteria: history of cholecystectomy, documented chronic liver disease in the patient, failure to fast on the day of the blood test, inflammatory bowel disease
- Patients requiring emergency intervention (myocardial infarction, acute aortic or mitral insufficiency, cardiogenic shock).
- AS of rheumatic origin, infective endocarditis.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06021535
Start Date
January 1 2024
End Date
December 31 2028
Last Update
September 1 2023
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