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

NCT02499419 | Unknown

• 1 other identifier: 0294-14-CTIL
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Prolapse

Outcome Measures

Primary Outcomes (1)

• Exercise capacity as a measure of maximal oxygen uptake (VO2max), Anaerobic threshold and work efficiency

  Within 30 days after the CPET test

Secondary Outcomes (2)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People diagnosed with MVP and no other cardiac problems.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

RAMBAM health care center

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Mitral Valve Prolapse

Condition Hierarchy (Ancestors)

Heart Valve Prolapse; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: July 16, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: March 1, 2017
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

IL (1)