CompletedNot Applicable

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

Denmark26 participantsStarted 2019-09-01

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 2 hours

Trial details

NCT IDNCT05580237

SponsorAarhus University Hospital Skejby

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-01

View on ClinicalTrials.gov More Aortic Valve Stenosis trials

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.