Outcome, Recuperation and Hemodynamics in Aortic Stenosis (PROCARE-AS)
Primary Purpose
Aortic Valve Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
CPET, 6MWT, QOL assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Aortic Valve Stenosis
Eligibility 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
Sites / Locations
- Jessa ZiekenhuisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
TAVI
AVR
Arm Description
Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment
Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment, Myocardial + aortic valve biopsy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05272020
Brief Title
Outcome, Recuperation and Hemodynamics in Aortic Stenosis
Acronym
PROCARE-AS
Official Title
PRognosis of Outcome and Recuperation of Cardiac Hemodynamic Function After Aortic Valve REplacement in Aortic Valve Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jessa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAVI
Arm Type
Other
Arm Description
Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment
Arm Title
AVR
Arm Type
Other
Arm Description
Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment, Myocardial + aortic valve biopsy
Intervention Type
Diagnostic Test
Intervention Name(s)
CPET, 6MWT, QOL assessment
Intervention Description
Preoperative and postoperative (6 months + 18 months) assessment
Primary Outcome Measure Information:
Title
Outcome defined by the occurrence of a major cardiac event
Description
either
Death of cardiovascular origin, or
Hospitalization for heart failure, or
Deterioration of hemodynamic function during an 18 month follow-up period after AVR.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Hoedemakers, MD
Phone
+32498260617
Email
sarahhoed@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lieven Herbots, MD PhD
Organizational Affiliation
Jessa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Hoedemakers
Phone
0498260617
Email
sarahhoed@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Outcome, Recuperation and Hemodynamics in Aortic Stenosis
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