Outcome, Recuperation and Hemodynamics in Aortic Stenosis

NCT05272020 | Unknown

• 1 other identifier: f/2020/173
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Outcome defined by the occurrence of a major cardiac event

  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.

  18 months

Study Arms (2)

TAVI

OTHER

Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment

Diagnostic Test: CPET, 6MWT, QOL assessment

AVR

OTHER

Cardiopulmonary exercise testing, 6 minute walking test, QOL assessment, Myocardial + aortic valve biopsy

Diagnostic Test: CPET, 6MWT, QOL assessment

Interventions

CPET, 6MWT, QOL assessment DIAGNOSTIC_TEST

Preoperative and postoperative (6 months + 18 months) assessment

AVR; TAVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Every patient above 18 years of age with an echocardiographic established moderate to severe AS
• A guideline indication for aortic valve replacement therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Lieven Herbots, MD PhD

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Hoedemakers, MD

CONTACT

+32498260617; sarahhoed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sarah Hoedemakers

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: March 22, 2021
• Primary Completion: September 30, 2023
• Study Completion: March 31, 2024
• Last Updated: March 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)