WithdrawnNot Applicable

CPX in Paradoxical Low Flow Aortic Stenosis

Stopped: Inability to execute internal logistics to begin enrollment

United States0Started 2017-09-30

Plain-language summary

Severe aortic stenosis is a condition with poor life expectancy once it becomes symptomatic. There are no prospective studies illustrating the utility of cardiopulmonary stress (CPX) testing in diagnosing and prognosticating patients with paradoxically low gradient and low flow severe aortic stenosis. We aim to prospectively investigate the utility of CPX in this patient population with the hypothesis that utilizing CPX parameters would better identify higher risk patients warranting further evaluation and possibly intervention sooner.

Who can participate

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: * Aortic valve area \<1 cm2 * Mean aortic pressure gradient \<40 mmHg, * Left ventricular ejection fraction \>50% by 2D transthoracic echocardiography Exclusion Criteria: * Ischemic heart disease * Severe mitral valve disease (regurgitation or stenosis) * Moderate or severe aortic regurgitation * Pulmonary hypertension (PA pressure \>50 mmHg) * COPD * Uncontrolled hypertension (Systolic BP or Diastolic BP greater than 150/90) * Inability or unwillingness to 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

Functional status

Timeframe: August 30 2017-April 30 2017

Trial details

NCT IDNCT05481814

SponsorHenry Ford Health System

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-04-01

View on ClinicalTrials.gov More Aortic Valve Stenosis trials

Plain-language summary

Who can participate

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.