Outcome, Recuperation and Hemodynamics in Aortic Stenosis

Aortic Valve Stenosis Clinical Trial

— PROCARE-AS  

Official title:

PRognosis of Outcome and Recuperation of Cardiac Hemodynamic Function After Aortic Valve REplacement in Aortic Valve Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05272020
• Other study ID #: f/2020/173
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2022
• Source: Jessa Hospital
• Contact: Sarah Hoedemakers, MD
• Phone: +32498260617
• Email: sarahhoed[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Indication for aortic valve replacement (AVR) in aortic stenosis (AS) is currently based on the classical triad of clinical AS symptoms, estimation of AS severity, and cardiac repercussion at rest. However, presence of symptoms in elderly is often subjective and underreported, and cardiac function analysis at rest underestimates the true impact of the chronic afterload increase. This complicates the diagnosis and hampers timely aortic valve replacement therapy with an impact on prognosis and cardiac function recovery. Exercise imaging in AS may reveal underlying cardiac repercussion and symptoms at an earlier stage and therefore impact prognosis and cardiac function recovery after AVR. Therefore the principal objective of this study is to reveal the factors that determine clinical outcome and hemodynamic function recovery after AVR in AS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Every patient above 18 years of age with an echocardiographic established moderate to severe AS

• A guideline indication for aortic valve replacement therapy

Exclusion Criteria:

• Unable to perform exercise testing

• Previous aortic valve intervention

• More than moderate other valvular disease

• Patients refusing participation or unwilling to sign the informed consent

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Diagnostic Test:
• CPET, 6MWT, QOL assessment
Preoperative and postoperative (6 months + 18 months) assessment

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome defined by the occurrence of a major cardiac event	either; Death of cardiovascular origin, or; Hospitalization for heart failure, or; Deterioration of hemodynamic function during an 18 month follow-up period after AVR.	18 months