Exercise capacity, muscle oxygenation, and aortic stiffness after mitral valve intervention
Official title: Comparison of Exercise Capacity, Muscle Oxygenation and Aortic Stiffness in Patients With a History of Mitral Valve Intervention for Mitral Stenosis With Healthy Subjects
Run by Gazi University · NCT07394998 · Data updated 2026-11-12
This project will test whether adults who had a mitral valve intervention have lower exercise capacity, altered muscle oxygen levels, and stiffer aortas compared with healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Gazi University Academic / other |
| Locations | 1 site (Ankara, Çankaya) |
| Status | Recruiting |
| Started | January 13, 2025 |
| Main results expected | October 30, 2026 |
| Study ends | December 2026 |
| Registry record updated | August 4, 2026 |
| Trial ID | NCT07394998 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 who had mitral valve intervention for mitral stenosis at least three months ago and who can safely perform exercise testing are the ideal candidates.
✕Probably not a fit
Patients with other valve interventions (e.g., aortic valve procedures), acute infections, or orthopedic/neurologic/psychological issues that limit function, and controls with chronic disease or heavy smoking history, are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center observational comparison of adults (18–80) who underwent mitral valve intervention at least three months earlier and age-matched healthy controls. Participants will undergo cardiopulmonary exercise testing to measure exercise capacity, noninvasive measures of aortic stiffness (such as pulse wave velocity), and muscle oxygenation monitoring during activity. The study excludes patients with recent infection, other valve interventions, or conditions that limit functional capacity, and excludes controls with chronic disease or heavy smoking history. Findings will be used to characterize persistent physiologic limitations after mitral valve intervention and inform rehabilitation strategies.
Why it matters
Potential benefit: If successful, results could help customize post-intervention rehabilitation and monitoring to improve exercise tolerance and day-to-day function for patients with mitral stenosis.
How similar studies have gone: Previous work is limited and often focuses on patients after percutaneous balloon valvuloplasty, so studies specifically measuring muscle oxygenation and aortic stiffness after surgical or other mitral interventions remain sparse.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Çankaya, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Özden SEÇKİN GÖBÜT, Dr — Gazi University
- Study coordinator: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
- Email: meralbosnak@gazi.edu.tr
- Phone: +90(312)2162647
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Registry of mitral stenosis patients treated with percutaneous mitral balloon commissurotomy
See how people with mitral stenosis do after percutaneous mitral balloon commissurotomy (PMBC) and which method best determines the Inoue balloon size.
-
Surgical implantation of a polymer prosthetic mitral or aortic valve
This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.
-
Abbott Cephea registry for mitral valve disease
Collects clinical information on adults with symptomatic mitral valve disease to see how correcting the valve with the Cephea system affects outcomes for patients who might be candidates for transcatheter mitral valve replacement.
-
Using lung ultrasound to improve outcomes in cardiac surgery patients
This study is testing if using lung ultrasound can help doctors find lung problems earlier in patients after heart surgery compared to regular X-rays and CT scans.
-
MITRAL II Pivotal: Transcatheter mitral valve replacement for severe mitral annular calcification
This trial tests whether placing an Edwards SAPIEN transcatheter valve through a transseptal approach helps high-surgical-risk adults with severe mitral annular calcification and symptomatic mitral valve dysfunction.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.