Exercise capacity, muscle oxygenation, and aortic stiffness after mitral valve intervention

Comparison of Exercise Capacity, Muscle Oxygenation and Aortic Stiffness in Patients With a History of Mitral Valve Intervention for Mitral Stenosis With Healthy Subjects

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
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Gazi University (Academic / other)
• Locations: 1 site (Ankara, Çankaya)
• Trial ID: NCT07394998 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Ankara, Çankaya

• 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.

Conditions Mitral Stenosis; cardiopulmonary exercise test; aortic stiffness; muscle oxygenation; physical activity; mitral stenosis