Pressure Gradient vs. Flow Relationships in Patients With Symptomatic Valvular Aortic Stenosis

NCT05580237 | Completed

• 1 other identifier: 1-10-72-71-19
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present study is to investigate to hemodynamic profile at rest and during peak exercise of patients with suspected severe aortic stenosis and to compare flow- and pressure changes between high gradient patients and low gradient patients.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Pressure and flow relationships across the aortic valve during rest and during supine exercise

  Pressure drop across the aortic valve measured invasively. Flow across the valve estimated by right heart catheterization in the absence of aortic valve regurgitation.

  2 hours

Study Arms (1)

Severe aortic valve stenosis

Procedure: Simultaneous right and left heart catheterization

Interventions

Simultaneous right and left heart catheterization PROCEDURE

Pressure recordings across the aortic valve with simultaneous flow measurements by right heart catheterization, during rest and during supine exercise.

Severe aortic valve stenosis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected severe AS scheduled for evaluation for aortic valve intervention

You may qualify if:

• Patients with suspected severe AS scheduled for evaluation for aortic valve intervention:
• LVEF \> 50 %
• AVA \< 1.0 cm2
• Symptomatic - at least equivalent to NYHA functional class II

You may not qualify if:

• Congenital heart disease
• Severe coronary artery disease (main stem, proximal LAD or 3 vessel disease)
• Moderate or severe aortic valve regurgitation
• Moderate or severe mitral valve regurgitation or stenosis
• Moderate or severe pulmonary valve regurgitation or stenosis
• Moderate or severe tricuspid valve regurgitation or stenosis
• Severe pulmonary hypertension (tricuspid valve pressure gradient of 60 mmHg)
• Right ventricular dysfunction (TAPSE \< 17 mm)
• Restrictive cardiomyopathy or cardiac amyloidosis
• Constrictive pericarditis
• Inability to perform supine bicycle exercise

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Henrik Vase, MD, PhD

  Department of Cardiology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Specialist, MD, PhD

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: October 14, 2022
• Study Start: September 1, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

DK (1)