Outcome, Recuperation and Hemodynamics in Aortic Stenosis

Not Applicable

• Conditions: Aortic Valve Stenosis
• Interventions: Diagnostic Test: CPET, 6MWT, QOL assessment

• Registration Number: NCT05272020
• Lead Sponsor: Jessa Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-22
• Status Verified: 2022-02
• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-02-28
• Last Update Submitted: 2022-02-28
• Study First Posted: 2022-03-09
• Last Update Posted: 2022-03-09
• Primary Completion: 2023-09-30
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAVI	CPET, 6MWT, QOL assessment	Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment
AVR	CPET, 6MWT, QOL assessment	Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment, Myocardial + aortic valve biopsy

Primary Outcome Measures

Name	Time	Method
Outcome defined by the occurrence of a major cardiac event	18 months	either; 1. Death of cardiovascular origin, or; 2. Hospitalization for heart failure, or; 3. Deterioration of hemodynamic function during an 18 month follow-up period after AVR.

Trial Locations

Locations (1)

Jessa Ziekenhuis; 🇧🇪 Hasselt, Limburg, Belgium