Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve (NCT02727504) | Clinical Trial Compass
CompletedNot Applicable
Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve
France86 participantsStarted 2016-05-11
Plain-language summary
Investigators sought to demonstrate that the increase in the stroke volume during a dobutamine stress echocardiography might impact the prognosis of a patient addressed for a low flow low gradient suspected severe aortic valve stenosis.
Who can participate
Age range
45 Years – 90 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:
* Patient from 45 to 90 years old
* Patient agreeing freely to participate in the study
* Aortic surface area suspected to be \< 1 cm² or \< 0.6 cms²/m²
* Low aortic gradient defined by a mean pressure gradient \< 40 mmHg
* Aortic low flow defined by: a stroke volume indexed \< 35 ml/m2
* Any contra-indication for the realization of the MRI
Exclusion Criteria:
* Heart rhythm disorders
* Presence of comorbidity altering the 2-year prognosis of a patient (cancer, terminal renal insufficiency (GFR 30 ml / min / 1,73m2), liver cirrhosis, respiratory insufficiency (VEMS 1 L)
* Presence of a concomitant valvular heart disease with stenosis or regurgitation \> moderated
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
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
1
Number of death of all cause
Timeframe: Month 12
2
Number of emergent hospitalization for any cardiovascular reason