Exercise Capacity Evaluation in Patients With Non-rheumatic Mitral Valve Prolapse (MVP)

Rambam Health Care Campus

Status: Unknown

Conditions: Mitral Valve Prolapse

Study type: Observational

Funder types: Other

Identifiers

NCT02499419

0294-14-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 6 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

80 participants in 4 patient groups

Healthy

Description:

Individuals without any known heart/ respiratory/ metabolic problems that might limit their exercise capacity

Mild MVP

Description:

0 or 1 of the following secondary risk factors: Mild MR Flail leaflet Left atrial diameter \> 40 mm Atrial fibrillation Age ≥ 50

Moderate MVP

Description:

2 or more of the above secondary risk factors.

Severe MVP

Description:

1 or more of the following primary risk factors: EF \< 50% MR ≥ moderate