Assessment of Exercise Capacity, Muscle Oxygenation and Aortic Stiffness in Patients With Mitral … (NCT07394998) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of Exercise Capacity, Muscle Oxygenation and Aortic Stiffness in Patients With Mitral Stenosis
Turkey (Türkiye)40 participantsStarted 2025-01-13
Plain-language summary
Heart valve diseases are the most common cause of mortality and morbidity after coronary artery disease, hypertension, and heart failure. In patients with mitral stenosis, the narrowed valve restricts blood flow, causing symptoms such as shortness of breath, fatigue, exertional dyspnea, orthopnea, and paroxysmal nocturnal dyspnea. These patients may experience decreased exercise capacity and physical activity levels, deterioration in quality of life, and deterioration in respiratory function. When reviewing the literature, we see that the study groups evaluating these factors are generally not homogeneous, and most studies conducted in patients with mitral stenosis evaluate patients who have undergone percutaneous mitral balloon valvuloplasty.
Who can participate
Age range
18 Years – 80 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;
* Between the ages of 18-80
* Patients who have undergone mitral valve intervention due to mitral stenosis
* At least 3 months have passed since the intervention
Healthy controls;
* Between the ages of 18 and 80
* Agreeing to participate voluntarily in the study
Exclusion Criteria:
Patients;
* Patients who have undergone aortic valve intervention other than mitral valve intervention
* Acute infection
* Orthopedic, neurological or psychological disorders that will affect functional capacity
Healthy Controls;
* diagnosed chronic disease,
* acute infection
* A smoking history of at least 10 packs×years or more
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
Maximal Exercise Capacity
Timeframe: Through study completion, an average of 1 year
2
Muscle Oxygenation
Timeframe: Through study completion, an average of 1 year
3
Aortic Stiffness
Timeframe: Through study completion, an average of 1 year
4
Quality of Life (Short Form 36)
Timeframe: through study completion, an average of 1 year