Clinical trial NCT02499419: Exercise Capacity Evaluation in Patients With Non-rheumatic Mitral Valve Prolapse (MVP)
Official title: Exercise Capacity Evaluation in Patients With Non-rheumatic Mitral Valve Prolapse (MVP)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitral Valve Prolapse
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People diagnosed with MVP and no other cardiac problems.

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* MVP diagnosis
* Signing consent form (By parents if the patient is a minor)

Exclusion Criteria:

* Other congenital or acquired cardiac problems other than MVP.
* Patients with other diseases that can affect the exercise capacity.

Primary outcomes:
measure: Exercise capacity as a measure of maximal oxygen uptake (VO2max), Anaerobic threshold and work efficiency
timeFrame: Within 30 days after the CPET test
Secondary outcomes:
measure: Exercise capacity limitation as a measure of the O2-pulse, heart rate, blood pressure, blood saturation, ECG and the ventilatory equivalents.
timeFrame: Within 30 days after the CPET test
measure: 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
timeFrame: Within 30 days after the echo test
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: RAMBAM health care center
Study officials:
References: