CompletedNot Applicable

Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS

Switzerland50 participantsStarted 2018-05-31

Plain-language summary

The aim of this study is to test the diagnostic added value of Volume Challenge (VC) to low-dose dobutamine stress echocardiography (LDDSE) in patients with a low-flow, low-gradient aortic stenosis (LFLGAS). This study will assess if LDDSE plus VC allows to increase the proportion of patients in whom a true severe AS can be differentiated from a pseudo severe AS.

Who can participate

Age range

18 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: * Age \> 18 years * Written informed consent * Patients with LFLGAS (mean Gradient: \< 40 mmHg, AVA ≤ 1.0 cm2 (by continuity equation using LVOT diameter) SVI ≤ 35 ml/m2), by rest TTE Exclusion Criteria: * Hypersensitivity to dobutamine or midazolam * Lack of safe contraception defined as: Female participants of childbearing potential not using and not willing to continue contraception for study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices. * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc., * Enrolment of the investigator, his/her family members, employees and other dependent persons * Previous enrolment into the current study, ADDITIONAL SPECIFIC EXCLUSION CRITERIA REGARDING STRESS ECHOCARDIOGRAPHY: * Systolic left ventricular ejection fraction (LVEF) \< 20% * More than mild aortic regurgitation * Mitral valve disease, defined by mitral valve area \< 2.0 cm2 or more than mild mitral regurgitation * Unstable angina * Acute pulmonary oedema * Signs of relevant left ventricular heart failure defined as crackles more than one fourth of lung field on auscultation * Signs of relevant right ventricular heart failure defined as central venous pressure (CVP) \> 15 mmHg estimated with dilatation and collapsibility of vena cava inferior (VCI) * Severe pulmonary, renal or hepatic disease ADDITIONAL SPECIFIC EXCLUSION CRITERIA REGAR…

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

Diagnosis of true severe AS

Timeframe: Measures taken during echocardiograph a few minutes after administration of VC

Trial details

NCT IDNCT03617406

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Aortic Valve Stenosis trials