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

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.

Study Overview

• Status: Unknown
• Conditions: 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 .

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Center
    • Contact: Abraham Lorber, MD; Phone Number: 972-4-8542275
    • Principal Investigator: Abraham Lorber, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People diagnosed with MVP and no other cardiac problems.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Estimate): July 16, 2015
• Last Update Submitted That Met QC Criteria: July 13, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Heart Valve Prolapse; Prolapse; Mitral Valve Prolapse
• Other Study ID Numbers: 0294-14-CTIL