Exercise Capacity Evaluation in Patients With Non-rheumat... | NCT02499419

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

NCT02499419

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Jul 16, 2015Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Mitral Valve Prolapse

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Oct 2016Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Oct 27, 2014

First Submission Date that Met QC Criteria

Jul 13, 2015

First Posted Date

Jul 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2015

Last Update Posted Date

Jul 16, 2015Estimated

Description Module

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 .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

People diagnosed with MVP and no other cardiac problems.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RAMBAM health care center		Haifa		31096	Israel

Condition Browse Module

MeSH Terms

ID	Term
D008945	Mitral Valve Prolapse

Ancestor Terms

ID	Term
D016127	Heart Valve Prolapse
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided