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

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Unknown status

CT.gov ID

NCT02499419

Collaborator

(none)

Enrollment

Location

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Prolapse

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 .

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Healthy Individuals without any known heart/ respiratory/ metabolic problems that might limit their exercise capacity
Mild MVP 0 or 1 of the following secondary risk factors: Mild MR Flail leaflet Left atrial diameter > 40 mm Atrial fibrillation Age ≥ 50
Moderate MVP 2 or more of the above secondary risk factors.
Severe MVP 1 or more of the following primary risk factors: EF < 50% MR ≥ moderate

Outcome Measures

Primary Outcome Measures

Exercise capacity as a measure of maximal oxygen uptake (VO2max), Anaerobic threshold and work efficiency [Within 30 days after the CPET test]

Secondary Outcome Measures

Exercise capacity limitation as a measure of the O2-pulse, heart rate, blood pressure, blood saturation, ECG and the ventilatory equivalents. [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 [Within 30 days after the echo test]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RAMBAM health care center	Haifa		Israel	31096

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT02499419

Other Study ID Numbers:

0294-14-CTIL

First Posted:

Jul 16, 2015

Last Update Posted:

Jul 16, 2015

Last Verified:

Jul 1, 2015

Additional relevant MeSH terms:

Mitral Valve Prolapse

Prolapse

Study Results

No Results Posted as of Jul 16, 2015