Clinical Trial: Exercise Capacity Evaluation in Patients With Non-rheumatic Mitral Valve Prolapse (MVP)
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Exercise Capacity Evaluation in Patients With Non-rheumatic Mitral Valve Prolapse (MVP)
Brief Summary:
Mitral valve prolapse (MVP) is a relatively common cardial problem in which one or more of the leaflets of the mitral valve prolapse during systole into the left atrium.
The disease is very heterogeneous and can vary from a benign disease with almost no impact on the patient's life to a severe cardiac problem with many complications and high mortality rate.
The purpose of the study is to see if the investigators can find a relation between the severity of the MVP to the exercise capacity of the patient. The investigators also want to see if they can find a difference between the exercise capacity of mild MVP patients and healthy people.
To evaluate the exercise capacity of the subjects the investigators use Cardiopulmonary Exercise Testing (CPET). CPET is probably the best known way to get a full picture of the subject's functions during exercise. By combining gas exchange monitoring and ECG during a controlled exercise in which the subject reaches maximal effort, the test gives information about the cardiac, the pulmonary and the metabolic functions of the subject. This information can help identify if there is a problem to perform exercise properly and more specifically if the limitation is due to a cardiac, pulmonary or metabolic problem.
Detailed Summary:
Mitral valve prolapse (MVP) is a relatively common cardial problem in which one or more of the leaflets of the mitral valve prolapse during systole into the left atrium.
The disease is very heterogeneous and can vary from a benign disease with almost no impact on the patient's life to a severe cardiac problem with many complications and high mortality rate .
The purpose of the study is to see if the investigators can find a relation between the severity of the MVP to the exercise capacity of the patient. The investigators also want to see if they can find a difference between the exercise capacity of mild MVP patients and healthy people.
To evaluate the exercise capacity of the subjects the investigators use Cardiopulmonary Exercise Testing (CPET). CPET is probably the best known way to get a full picture of the subject's functions during exercise. By combining gas exchange monitoring and ECG during a controlled exercise in which the subject reaches maximal effort, the test gives information about the cardiac, the pulmonary and the metabolic functions of the subject. This information can help identify if there is a problem to perform exercise properly and more specifically if the limitation is due to a cardiac, pulmonary or metabolic problem.
Sponsor: Rambam Health Care Campus
Current Primary Outcome: Exercise capacity as a measure of maximal oxygen uptake (VO2max), Anaerobic threshold and work efficiency [ Time Frame: Within 30 days after the CPET test ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Exercise capacity limitation as a measure of the O2-pulse, heart rate, blood pressure, blood saturation, ECG and the ventilatory equivalents. [ Time Frame: Within 30 days after the CPET test ]
- The severity of the MVP as a measure of the mitral regurgitation, ejection fraction, left atrial diameter, the presence of flail leaflet, the presence of atrial fibrillations and the age of the subject [ Time Frame: Within 30 days after the echo test ]
Original Secondary Outcome: Same as current
Information By: Rambam Health Care Campus
Dates:
Date Received: October 27, 2014
Date Started: September 2015
Date Completion: March 2017
Last Updated: July 13, 2015
Last Verified: July 2015
