Assessment of Exercise Capacity, Muscle Oxygenation and Aortic Stiffness in Patients With Mitral Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mitral Stenosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
The secondary objective of the study is to compare respiratory muscle strength and endurance, pulmonary function, and physical activity levels in patients who have undergone surgery for mitral stenosis with those in healthy individuals.
Primary outcomes are exercise capacity, muscle oxygenation, aortic stiffness, and quality of life.
Secondary outcomes are respiratory muscle strength, respiratory muscle endurance, pulmonary function and physical activity level.
Primary outcome measures
- Maximal Exercise Capacity [Time frame: Through study completion, an average of 1 year]
- Muscle Oxygenation [Time frame: Through study completion, an average of 1 year]
- Aortic Stiffness [Time frame: Through study completion, an average of 1 year]
- Quality of Life (Short Form 36) [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (8)
- Respiratory Muscle Strength [Time frame: Through study completion, an average of 1 year]
- Respiratory Muscle Endurance [Time frame: Through study completion, an average of 1 year]
- Pulmonary Function (Forced vital capacity (FVC)) [Time frame: Through study completion, an average of 1 year]
- Pulmonary Function (Forced expiratory volume in first second (FEV1)) [Time frame: Through study completion, an average of 1 year]
- Pulmonary Function (FEV1/FVC) [Time frame: Through study completion, an average of 1 year]
- Pulmonary Function (Flow rate 25-75% of forced expiratory volume (FEF25-75%)) [Time frame: Through study completion, an average of 1 year]
- Pulmonary Function (Peak flow rate (PEF)) [Time frame: Through study completion, an average of 1 year]
- Physical Activity Level [Time frame: Through study completion, an average of 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Turkey (Türkiye) · 1 center
- Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, — Ankara
Publications
- Lopaschuk GD, Jaswal JS. Hypoxia-induced adaptation to mitral regurgitation: a role for K ATP channel up-regulation? J Am Coll Cardiol. 2012 Jan 24;59(4):397-9. doi: 10.1016/j.jacc.2011.09.056. Epub 2011 Nov 30. No abstract available. PMID 22133354
- Kopp R, Dommann K, Rossaint R, Schalte G, Grottke O, Spillner J, Rex S, Marx G. Tissue oxygen saturation as an early indicator of delayed lactate clearance after cardiac surgery: a prospective observational study. BMC Anesthesiol. 2015 Oct 30;15:158. doi: 10.1186/s12871-015-0140-7. PMID 26518485
- Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circula PMID 33332149
- American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available. PMID 12186831
- Reference Values for Arterial Stiffness' Collaboration. Determinants of pulse wave velocity in healthy people and in the presence of cardiovascular risk factors: 'establishing normal and reference values'. Eur Heart J. 2010 Oct;31(19):2338-50. doi: 10.1093/eurheartj/ehq165. Epub 2010 Jun 7. PMID 20530030
- American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available. PMID 12524257
- Inci S, Nar G, Erol MK, Demirelli S, Duman H, Serdar S, Erol F. The effects of successful percutaneous mitral balloon valvuloplasty on acute and intermediate term aortic stiffness. Echocardiography. 2015 May;32(5):813-8. doi: 10.1111/echo.12799. Epub 2014 Oct 27. PMID 25345485
- Demirbag R, Sade LE, Aydin M, Bozkurt A, Acarturk E. The Turkish registry of heart valve disease. Turk Kardiyol Dern Ars. 2013 Jan;41(1):1-10. doi: 10.5543/tkda.2013.71430. PMID 23518931
Identifiers
NCT: NCT07394998 · 2024 1390