Assessment of Exercise Capacity, Muscle Oxygenation and Aortic Stiffness in Patients With Mitral Stenosis

NCT07394998 | Recruiting

• 1 other identifier: 2024 1390
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  through study completion, an average of 1 year

Secondary Outcomes (8)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 patients with a history of mitral valve intervention for mitral stenosis and 30 healthy individuals will be recruited.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, Çankaya, 06490, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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. Circulation. 2021 Feb 2;143(5):e35-e71. doi: 10.1161/CIR.0000000000000932. Epub 2020 Dec 17.

  PMID: 33332149 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Laufer-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.

  PMID: 27865723 BACKGROUND

• van 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.

  PMID: 28069013 BACKGROUND

MeSH Terms

Conditions

Mitral Valve Stenosis; Motor Activity

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Ebrar TÜLÜMENOĞLU, Pt

  Gazi University

  STUDY CHAIR

• Özden SEÇKİN GÖBÜT, Dr

  Gazi University

  PRINCIPAL INVESTIGATOR

• Serkan ÜNLÜ, Dr

  Gazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

CONTACT

+90(312)2162647; meralbosnak@gazi.edu.tr

Ebrar TÜLÜMENOĞLU, Pt

CONTACT

25854401007@gazi.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 6, 2026
• Study Start: January 13, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)