PROCARE-AS: Outcome, Recuperation and Hemodynamics in Aortic Stenosis

Sponsor
Jessa Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05272020
Collaborator
(none)
150
1
2
36.3
4.1

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
  • Diagnostic Test: CPET, 6MWT, QOL assessment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
PRognosis of Outcome and Recuperation of Cardiac Hemodynamic Function After Aortic Valve REplacement in Aortic Valve Stenosis
Actual Study Start Date :
Mar 22, 2021
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Mar 31, 2024

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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

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.
Responsible Party:
Sarah Hoedemakers, Sarah Hoedemakers, Jessa Hospital
ClinicalTrials.gov Identifier:
NCT05272020
Other Study ID Numbers:
  • f/2020/173
First Posted:
Mar 9, 2022
Last Update Posted:
Mar 9, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022