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Clinical Trials/NCT07394998
NCT07394998RecruitingNot Applicable

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

Gazi University1 site in 1 country40 target enrollmentStarted: January 13, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
Maximal Exercise Capacity

Study Overview

Brief 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.

Detailed Description

In mitral valve stenosis, blood flow from the left atrium to the left ventricle is mechanically restricted, resulting in increased pressure in the left atrium, pulmonary vascular bed, and right chambers of the heart. The narrowed mitral valve obstructs the flow of blood from the lungs to the heart, causing shortness of breath in patients. Increased blood volume in the left atrium may cause palpitations. Other symptoms include fatigue, exertional dyspnea, orthopnea, paroxysmal nocturnal dyspnea, chest pain, and dizziness.

Patients with mitral stenosis are expected to have decreased exercise capacity due to restrictive lung function, chronotropic insufficiency, limited stroke volume, and the effects of peripheral factors. Studies evaluating the exercise capacity of patients who have undergone surgery for mitral stenosis are limited.

After cardiac surgery, oxygen saturation decreases in the acute period, and hemodynamic and systemic oxygenation are often impaired. It has been suggested that muscle deoxygenation may also occur in patients with mitral stenosis due to these reasons. Studies investigating skeletal muscle oxygenation after mitral valve surgery are limited in the literature. While surgery for heart valve lesions improves cardiac function, changes in the thoracic compartment are major causes of mortality and morbidity. These changes reduce cardiorespiratory capacity, leading to physical inactivity, loss of muscle strength, and loss of fitness in patients.

Inspiratory muscle performance is impaired in patients who have undergone valve replacement surgery. Better inspiratory muscle performance in these patients is associated with better physical function. This relationship between respiratory muscle strength and exercise capacity demonstrates the importance of assessing respiratory muscle strength. Mitral valve stenosis is associated with impaired aortic stiffness. In patients with heart failure, aortic stiffening plays a role in hemodynamic deterioration due to its adverse effect on left ventricular function and coronary artery perfusion. In conclusion, aortic stiffness has been shown to exacerbate the disease through multiple mechanisms. Inadequate physical activity after heart valve surgery is associated with a higher mortality rate, while adequate physical activity prevents cardiovascular events and reduces mortality in the long term. Physical activity is an important prognostic factor in patients who have undergone cardiac surgery. The quality of life of patients improves after heart valve surgery. The extent of improvement may vary depending on the surgical method used.

The primary objective of the study is to compare exercise capacity, muscle oxygenation, aortic stiffness, and quality of life in patients who have undergone surgery for mitral stenosis with those in healthy individuals.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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 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

Arms & Interventions

Healthy Controls Group

Healthy controls will be evaluated for exercise capacity with the Cardiopulmonary Exercise Test (CPET), muscle oxygenation with a near-infrared spectroscopy device, respiratory functions with a spirometer, respiratory muscle strength with a mouth pressure measurement device, respiratory muscle endurance with an incremental threshold loading respiratory muscle endurance test, aortic stiffness with an arteriograph, physical activity level with a multisensor physical activity monitor, and quality of life with the SF-36 Short Form.

Patients group

This group includes patients who have undergone mitral stenosis intervention for mitral stenosis. Patients exercise capacity using Cardiopulmonary Exercise Test (CPET), muscle oxygenation with a near-infrared spectroscopy device, respiratory functions with a spirometer, respiratory muscle strength with a mouth pressure measurement device, respiratory muscle endurance with an incremental threshold loading respiratory muscle endurance test, aortic stiffness with an arteriograph, physical activity level with a multisensor physical activity monitor and quality of life with the SF-36 Short Form will be evaluated.

Outcomes

Primary Outcomes

Maximal Exercise Capacity

Time Frame: Through study completion, an average of 1 year

Maximal Exercise capacity will be evaluated with Cardiopulmonary Exercise testing. The Cardiopulmonary Exercise Testing will be applied according to American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

Muscle Oxygenation

Time Frame: Through study completion, an average of 1 year

Peripheral muscle oxygen will be measured by near-infrared spectrometry. The device probes will be placed on the trunk and lower extremities. The device allows to display of the percentage of oxygen, the concentration of oxyhemoglobin, and deoxyhemoglobin, the difference between oxyhemoglobin and deoxyhemoglobin, and the total hemoglobin. These parameters will be evaluated in our study.

Aortic Stiffness

Time Frame: Through study completion, an average of 1 year

Aortic stiffness will be assessed non-invasively using the SphygmoCor XCEL® device, whose validity and reliability have been proven. The device measures carotid-femoral pulse wave velocity (cfPWV).

Quality of Life (Short Form 36)

Time Frame: through study completion, an average of 1 year

Health-related quality of life will be assessed using the valid and reliable Short Form 36 (SF-36). The SF-36 consists of a total of 36 items across 8 health domains. The 8 health domains assessed are general health, physical functioning, social functioning, physical limitations due to health problems, emotional limitations due to health problems, pain, mental health, and energy/vitality. It assesses the individual's last month using a Likert scale. Each health domain is scored between 0 and 100. A higher score indicates better health status.

Secondary Outcomes

  • Respiratory Muscle Strength(Through study completion, an average of 1 year)
  • Respiratory Muscle Endurance(Through study completion, an average of 1 year)
  • Pulmonary Function (Forced vital capacity (FVC))(Through study completion, an average of 1 year)
  • Pulmonary Function (Forced expiratory volume in first second (FEV1))(Through study completion, an average of 1 year)
  • Pulmonary Function (FEV1/FVC)(Through study completion, an average of 1 year)
  • Pulmonary Function (Flow rate 25-75% of forced expiratory volume (FEF25-75%))(Through study completion, an average of 1 year)
  • Pulmonary Function (Peak flow rate (PEF))(Through study completion, an average of 1 year)
  • Physical Activity Level(Through study completion, an average of 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Meral Boşnak Güçlü

Prof. Dr.

Gazi University

Study Sites (1)

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