Mitral StenosisNCT07394998
Assessment of Exercise Capacity, Muscle Oxygenation and Aortic Stiffness in Patients With Mitral Stenosis
An observational study of Mitral Stenosis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mitral Stenosis
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 patients with a history of mitral valve intervention for mitral stenosis and 30 healthy individuals will be recruited.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ebrar TÜLÜMENOĞLU, Pt contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Çankaya, 06490
Meral BOŞNAK GÜÇLÜ, Prof. Dr., +90(312)2162647, meralbosnak@gazi.edu.tr
Ebrar TÜLÜMENOĞLU, Pt, +905434157799, ebrar.tulumenoglu@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Mitral Stenosis
- Keywords
- cardiopulmonary exercise test, aortic stiffness, muscle oxygenation, physical activity, mitral stenosis
- Medical subject headings
- Mitral Valve Stenosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Exercise Capacity
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.
Measured: Through study completion, an average of 1 year
Muscle Oxygenation
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.
Measured: Through study completion, an average of 1 year
Aortic Stiffness
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).
Measured: Through study completion, an average of 1 year
Quality of Life (Short Form 36)
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
Respiratory Muscle Strength
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were measured using a portable mouth pressure measuring device according to American Thoracic Society and European Respiratory Society criteria.
Measured: Through study completion, an average of 1 year
Respiratory Muscle Endurance
Respiratory muscle endurance will be assessed using the incremental threshold loading test.
Measured: Through study completion, an average of 1 year
Pulmonary Function (Forced vital capacity (FVC))
Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, forced vital capacity (FVC)was evaluated.
Measured: Through study completion, an average of 1 year
Pulmonary Function (Forced expiratory volume in first second (FEV1))
Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, forced expiratory volume in first second (FEV1) was evaluated.
Measured: Through study completion, an average of 1 year
Pulmonary Function (FEV1/FVC)
Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, FEV1/FVC was evaluated.
Measured: Through study completion, an average of 1 year
Pulmonary Function (Flow rate 25-75% of forced expiratory volume (FEF25-75%))
Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, Flow rate 25-75% of forced expiratory volume (FEF25-75%)was evaluated.
Measured: Through study completion, an average of 1 year
Pulmonary Function (Peak flow rate (PEF))
Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, peak flow rate (PEF) was evaluated.
Measured: Through study completion, an average of 1 year
Physical Activity Level
Physical activity level will be assessed using a multi-sensor activity monitor. The patient will wear the multi-sensor activity monitor continuously for 4 days using a belt at hip level on the non-dominant side.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start13 Jan 2025
- Primary completion30 Oct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Mitral StenosisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Ebrar TÜLÜMENOĞLU, Pt, Study chair, Gazi UniversityÖzden SEÇKİN GÖBÜT, Dr, Principal investigator, Gazi UniversitySerkan ÜNLÜ, Dr, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394998
- Sponsor's protocol ID
- 2024 1390
- Status last verified
- Aug 2026
- First submitted
- 31 Jan 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 22133354Kopp 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.
PubMed 26518485Otto 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. Circulation. 2021 Feb 2;143(5):e35-e71. doi: 10.1161/CIR.0000000000000932. Epub 2020 Dec 17.
PubMed 33332149American 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.
PubMed 12186831Reference 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.
PubMed 20530030American 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.
PubMed 12524257Inci 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.
PubMed 25345485Demirbag 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.
PubMed 23518931Laufer-Perl M, Gura Y, Shimiaie J, Sherez J, Pressman GS, Aviram G, Maltais S, Megidish R, Halkin A, Ingbir M, Biner S, Keren G, Topilsky Y. Mechanisms of Effort Intolerance in Patients With Rheumatic Mitral Stenosis: Combined Echocardiography and Cardiopulmonary Stress Protocol. JACC Cardiovasc Imaging. 2017 Jun;10(6):622-633. doi: 10.1016/j.jcmg.2016.07.011. Epub 2016 Nov 16.
PubMed 27865723van Laar C, TImman ST, Noyez L. Decreased physical activity is a predictor for a complicated recovery post cardiac surgery. Health Qual Life Outcomes. 2017 Jan 7;15(1):5. doi: 10.1186/s12955-016-0576-6.
PubMed 28069013
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07394998
- Acronym / sponsor ID
- 2024 1390
- Conditions
- Mitral Stenosis
- Keywords
- cardiopulmonary exercise test, aortic stiffness, muscle oxygenation, physical activity, mitral stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with a history of mitral valve intervention for mitral stenosis and 30 healthy individuals will be recruited.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Background: PubMed 22133354Lopaschuk 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.
- Background: PubMed 26518485Kopp 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.
- Background: PubMed 33332149Otto 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. Circulation. 2021 Feb 2;143(5):e35-e71. doi: 10.1161/CIR.0000000000000932. Epub 2020 Dec 17.
- Background: PubMed 12186831American 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.
- Background: PubMed 20530030Reference 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.
- Background: PubMed 12524257American 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.
- Background: PubMed 25345485Inci 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.
- Background: PubMed 23518931Demirbag 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.
- Background: PubMed 27865723Laufer-Perl M, Gura Y, Shimiaie J, Sherez J, Pressman GS, Aviram G, Maltais S, Megidish R, Halkin A, Ingbir M, Biner S, Keren G, Topilsky Y. Mechanisms of Effort Intolerance in Patients With Rheumatic Mitral Stenosis: Combined Echocardiography and Cardiopulmonary Stress Protocol. JACC Cardiovasc Imaging. 2017 Jun;10(6):622-633. doi: 10.1016/j.jcmg.2016.07.011. Epub 2016 Nov 16.
- Background: PubMed 28069013van Laar C, TImman ST, Noyez L. Decreased physical activity is a predictor for a complicated recovery post cardiac surgery. Health Qual Life Outcomes. 2017 Jan 7;15(1):5. doi: 10.1186/s12955-016-0576-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ebrar TÜLÜMENOĞLU, Pt contact
Ebrar TÜLÜMENOĞLU, Pt study chair
Gazi University
Özden SEÇKİN GÖBÜT, Dr principal investigator
Gazi University
Serkan ÜNLÜ, Dr principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Stenosis, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meral BOŞNAK GÜÇLÜ, Prof. Dr. (+90(312)2162647, meralbosnak@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Exercise Capacity (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07394998, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.