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

Pressure Gradient vs. Flow Relationships in Patients With Symptomatic Valvular Aortic Stenosis - a Comparison Between High- and Low Gradient Subtypes

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Procedure: Simultaneous right and left heart catheterization

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe aortic valve stenosis	Procedure: Simultaneous right and left heart catheterization; Pressure recordings across the aortic valve with simultaneous flow measurements by right heart catheterization, during rest and during supine exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Investigators: Principal Investigator: Henrik Vase, MD, PhD, Department of Cardiology, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 1-10-72-71-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No