PROCARE-AS: Outcome, Recuperation and Hemodynamics in Aortic Stenosis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: TAVI Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment |
Diagnostic Test: CPET, 6MWT, QOL assessment
Preoperative and postoperative (6 months + 18 months) assessment
|
Other: AVR Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment, Myocardial + aortic valve biopsy |
Diagnostic Test: CPET, 6MWT, QOL assessment
Preoperative and postoperative (6 months + 18 months) assessment
|
Outcome Measures
Primary Outcome Measures
- Outcome defined by the occurrence of a major cardiac event [18 months]
either Death of cardiovascular origin, or Hospitalization for heart failure, or Deterioration of hemodynamic function during an 18 month follow-up period after AVR.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Jessa Ziekenhuis | Hasselt | Limburg | Belgium | 3500 |
Sponsors and Collaborators
- Jessa Hospital
Investigators
- Principal Investigator: Lieven Herbots, MD PhD, Jessa Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- f/2020/173