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Outcome, Recuperation and Hemodynamics in Aortic Stenosis

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05272020
Acronym
PROCARE-AS
Enrollment
150
Registered
2022-03-09
Start date
2021-03-22
Completion date
2024-03-31
Last updated
2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

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.

Interventions

DIAGNOSTIC_TESTCPET, 6MWT, QOL assessment

Preoperative and postoperative (6 months + 18 months) assessment

Sponsors

Jessa Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Outcome defined by the occurrence of a major cardiac event18 monthseither 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.

Countries

Belgium

Contacts

Primary ContactSarah Hoedemakers, MD
sarahhoed@gmail.com+32498260617

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026